protocol_id stringclasses 263
values | section_number stringlengths 1 12 | title stringlengths 1 1.88k | content stringlengths 0 866k | merged_titles listlengths 0 491 |
|---|---|---|---|---|
NCT01271725 | 7.3.4.1 | Early stopping rule | 7.3.4.1 Early stopping rule An early stopping rule will be implemented in order to minimise the number of patients treated if BIBW 2992 (afatinib) were ineffective. When 20 evaluable patients (according to RECIST 1.1) have completed at least two courses of BIBW 2992 (afatinib) (or progressed during the first course), a... | [] |
NCT01271725 | 7.3.5 | Pharmacokinetic analyses | 7.3.5 Pharmacokinetic analyses Not applicable to this protocol | [] |
NCT01271725 | 7.3.6 | Pharmacodynamic analyses | 7.3.6 Pharmacodynamic analyses Not applicable to this protocol | [] |
NCT01271725 | 7.3.7 | Pharmacogenomic analyses | 7.3.7 Pharmacogenomic analyses Not applicable to this protocol | [] |
NCT01271725 | 7.4 | HANDLING OF MISSING DATA | 7.4 HANDLING OF MISSING DATA Patients will continue to be followed for progression after discontinuation of study treatment until they start new treatment. | [] |
NCT01271725 | 7.5 | RANDOMISATION | 7.5 RANDOMISATION This is an open-label non-randomised trial without a control group. No randomisation is involved in this trial. Eligible patients will be sequentially entered into the trial. | [] |
NCT01271725 | 7.6 | DETERMINATION OF SAMPLE SIZE | 7.6 DETERMINATION OF SAMPLE SIZE 40 patients would be expected to provide more than a 90% probability of observing at least 2 responders and a nearly 80% probability of observing at least 3. This is based on a binomial probability with an assumed underlying ORR of 10%. Taking into account the additional condition that ... | [] |
NCT01271725 | 8 | INFORMED CONSENT, DATA PROTECTION, TRIAL RECORDS | 8. INFORMED CONSENT, DATA PROTECTION, TRIAL RECORDS The trial will be carried out in compliance with the protocol, the principles laid down in the Declaration of Helsinki, version as of October 1996 (as long as local laws do not require to follow other versions), in accordance with the ICH Harmonised Tripartite Guideli... | [] |
NCT01271725 | 8.1 | STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED CONSENT | 8.1 STUDY APPROVAL, PATIENT INFORMATION, AND INFORMED CONSENT This trial will be initiated only after all required legal documentation has been reviewed and approved by the respective Institutional Review Board (IRB) / Independent Ethics Committee (IEC) and competent authority (CA) according to national and internation... | [] |
NCT01271725 | 8.2 | DATA QUALITY ASSURANCE | 8.2 DATA QUALITY ASSURANCE A quality assurance audit/inspection of this trial may be conducted by the sponsor or sponsor's designees or by IRBs/IECs or by regulatory authorities. The quality assurance auditor will have access to all medical records, the investigator's trial-related files and correspondence, and the inf... | [] |
NCT01271725 | 8.3 | RECORDS | 8.3 RECORDS Case Report Forms (CRFs) for individual patients will be provided by the sponsor, via remote data capture. For drug accountability, refer to [Section 4.1.8](#page-42-1). | [] |
NCT01271725 | 8.3.1 | Source documents | 8.3.1 Source documents Source documents provide evidence for the existence of the patient and substantiate the integrity of the data collected. Source documents are filed at the investigator's site. Data entered in the eCRFs that are transcribed from source documents must be consistent with the source documents or the ... | [] |
NCT01271725 | 8.3.2 | Direct access to source data and documents | 8.3.2 Direct access to source data and documents The investigator / institution will permit trial-related monitoring, audits, IRB / IEC review and regulatory inspection, providing direct access to all related source data / documents. CRFs/eCRFs and all source documents, including progress notes and copies of laboratory... | [] |
NCT01271725 | 8.3.3 | Storage of records | 8.3.3 Storage of records The sponsor must retain the essential documents according to the sponsor's SOPs. When it is no longer necessary for the trial site to retain the source documents and essential documents the sponsor must notify the head of the trial site. | [] |
NCT01271725 | 8.4 | LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE EVENTS | 8.4 LISTEDNESS AND EXPEDITED REPORTING OF ADVERSE EVENTS | [] |
NCT01271725 | 8.4.1 | Listedness | 8.4.1 Listedness To fulfil the regulatory requirements for expedited safety reporting, the sponsor evaluates whether a particular adverse event is "listed", i.e. is a known side effect of the drug or not. Therefore a unique reference document for the evaluation of listedness needs to be provided. For BIBW 2992 (afatini... | [] |
NCT01271725 | 8.4.2 | Expedited reporting to health authorities and IECs/IRBs | 8.4.2 Expedited reporting to health authorities and IECs/IRBs Expedited reporting of serious adverse events, e.g. suspected unexpected serious adverse reactions (SUSARs) to health authorities and IECs/IRBs, will be done according to local regulatory requirements. Further details regarding this reporting procedure are p... | [] |
NCT01271725 | 8.5 | STATEMENT OF CONFIDENTIALITY | 8.5 STATEMENT OF CONFIDENTIALITY Individual patient medical information obtained as a result of this trial is considered confidential and disclosure to third parties is prohibited with the exceptions noted below. Patient confidentiality will be ensured by using patient identification code numbers. Treatment data may be... | [] |
NCT01271725 | 8.6 | COMPLETION OF TRIAL | 8.6 COMPLETION OF TRIAL The trial will be considered complete when the last patient completes the last follow-up visit.For EU countries: The EC/competent authority in each participating EU member state needs to be notified about the end of the trial (last patient/patient out, unless specified differently in [Section 6.... | [] |
NCT01271725 | 9 | REFERENCES | 9. REFERENCES | [] |
NCT01271725 | 9.1 | PUBLISHED REFERENCES | 9.1 PUBLISHED REFERENCES - R01-0299 Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that over expresses HER2. N Engl J Med 2001; 344(11):783- 792. - R04-0474 Common terminology criteria for adverse events ... | [] |
NCT01271725 | 9.2 | UNPUBLISHED REFERENCES | 9.2 UNPUBLISHED REFERENCES U03-3218 Investigator's Brochure. BIBW 2992 MA2. Version 9. 1200. P1 - 1200.P5. 24 April 2009 - U09-1454-01 . Anti-tumor activity of the EGFR/HER2 inhibitor BIBW 2992 in a mouse model of human triple-negative breast cancer (cell line SUM-149). BIRCV15-09. 07 September 2009 - U09-1455-01 , Ant... | [] |
NCT01271725 | 9.3 | POSTERS/ONLINE PUBLICATIONS | 9.3 POSTERS/ONLINE PUBLICATIONS - P08-11756 Spicer JF, Harris D, Ang J, Chau M, Vizor S, Shahidi M, Uttenreuther-Fischer M, Bono JS de A phase I study of daily BIBW 2992 , an irreversible EGFR/HER2 dual kinase inhibitor, in combination with weekly paclitaxel. 33rd Ann Cong of the European Society for Medical Oncology (... | [] |
NCT01271725 | 10 | APPENDICES | 10. APPENDICES | [] |
NCT01271725 | 10.1 | APPENDIX 1 COCKCROFT-GAULT FORMULA | 10.1 APPENDIX 1 COCKCROFT-GAULT FORMULA Estimated creatinine clearance rate (eCCR) using Cockcroft-Gault formula | | (140-Age)X Mass (in kilograms) X [0.85 if Female] | |-----------|---------------------------------------------------| | eCCR= | | | | 72 X Serum Creatinine (in mg/dL) | | | | | | Or when serum creatinine... | [] |
NCT01271725 | 10.2 | APPENDIX 2 ECOG SCALE | 10.2 APPENDIX 2 ECOG SCALE | ECOG Performance Status Scale | | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Grade | Descriptions | | 0 | No... | [] |
NCT01271725 | 10.3 | APPENDIX 3 TUMOUR RESPONSE ASSESSMENT ACCORDING TO RECIST 1.1 | 10.3 APPENDIX 3 TUMOUR RESPONSE ASSESSMENT ACCORDING TO RECIST 1.1
Response criteria for target lesions | 1. Complete Response (CR): | Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have a reduction in short axisto taking as reference the baseline sum diameters | |... | [
"Response criteria for target lesions",
"Response criteria for non-target lesions",
"Time-point response"
] |
NCT01271725 | 10.4 | APPENDIX 4 LIST OF CYP3A4 SUBSTRATES, INHIBITORS, AND INDUCERS AND LIST OF POTENT INHIBITORS AND INDUCERS OF P-GLYCOPROTEIN | 10.4 APPENDIX 4 LIST OF CYP3A4 SUBSTRATES, INHIBITORS, AND INDUCERS AND LIST OF POTENT INHIBITORS AND INDUCERS OF P-GLYCOPROTEIN | [] |
NCT01271725 | 10.4.1 | List of CYP3A4 substrates, inhibitors, and inducers | 10.4.1 List of CYP3A4 substrates, inhibitors, and inducers | [] |
NCT01271725 | 10.4.2 | List of potent inhibitors and inducers of P-glycoprotein | 10.4.2. List of potent inhibitors and inducers of P-glycoprotein | Inhibitors | Inducers | |----------------|--------------------| | Amiodarone | Carbamazepine | | Azithromycin | Phenytoin | | Captopril | Rifampicin | | Carvedilol | St John's Wort | | Clarithromycin | Phenobarbital Salt | | Conivaptan | Tipranavir | | ... | [] |
NCT01271725 | 10.5 | APPENDIX 5 CLINICAL EVALUATION OF LIVER INJURY | 10.5 APPENDIX 5 CLINICAL EVALUATION OF LIVER INJURY | [] |
NCT01271725 | 10.5.1 | Introduction | 10.5.1 Introduction Alterations of liver laboratory parameters, as described in [section 5.2.2.1](#page-51-4) (Protocol-Specified Significant Events), are to be further evaluated using the following procedures. | [] |
NCT01271725 | 10.5.2 | Procedures | 10.5.2 Procedures Any elevation of ALT/AST and bilirubin qualifying as laboratory alert should be confirmed using the initial sample if possible. If the alert is confirmed on initial sample, or it is not possible to repeat testing using initial sample, the following must be completed; - 1) Evaluate the patient within 4... | [] |
NCT01271725 | 11 | SUMMARY OF CLINICAL TRIAL PROTOCOL MODIFICATIONS | 11. SUMMARY OF CLINICAL TRIAL PROTOCOL MODIFICATIONS Summary of Clinical Trial Protocol Modifications Sheet (SOMS) | Number of CTP modification | 1 | | |-------------------------------|-------------------------------------------------|--| | Date of CTP modification | 22nd December 2010 | | | EudraCT number | 2010-02194... | [
"Description of change 1. Change of Trial Clinical Monitor 2. Clarification of timing of ECG, LVEF evaluation and tumour assessments. Clarification of timing of transition from part A to part B. Clarification that CBC results required prior to chemotherapy. 3. Clarification of transition from part A to part B. Clar... |
NCT01296932 | 1 | INTRODUCTION | 1. INTRODUCTION | [] |
NCT01296932 | 1.1 | MEDICAL BACKGROUND | 1.1 MEDICAL BACKGROUND Chronic lymphocytic leukaemia (CLL) is the most common form of leukaemia in Europe and North America, accounting for approximately one third of all leukemias in these regions, with an estimated annual age-adjusted incidence of 3–5 per 100 000 persons. The disease is diagnosed most commonly in the... | [] |
NCT01296932 | 1.2 | DRUG PROFILE | 1.2 DRUG PROFILE BI 836826 is a antibody of the IgG1 isotype, directed against human CD37. CD37, a member of the tetraspanin superfamily, is a glycosylated cell surface protein which is predominantly expressed on B-cells, with highest expression levels on mature peripheral blood B-cells. The majority of malignant cells... | [] |
NCT01296932 | 2 | RATIONALE, OBJECTIVES, AND BENEFIT - RISK ASSESSMENT | 2. RATIONALE, OBJECTIVES, AND BENEFIT - RISK ASSESSMENT | [] |
NCT01296932 | 2.1 | RATIONALE FOR PERFORMING THE TRIAL | 2.1 RATIONALE FOR PERFORMING THE TRIAL CD37 is predominantly expressed on B-cells, with highest expression levels on mature peripheral blood B- cells, reduced levels on plasma cells and low levels on monocytes, Tcells, macrophages, and granulocytes [\(R08-2979,](#page-67-0) [R09-4740,](#page-68-0) [R09-4739\)](#page-67... | [] |
NCT01296932 | 2.2 | TRIAL OBJECTIVES | 2.2 TRIAL OBJECTIVES The primary objective of this trial is to determine the MTD of BI 836826. As BI 836826 is a new biological entity (NBE) and the MTD may not be reached, an optimal biological dose (OBD) may be defined instead, presuming pharmacokinetic or pharmacodynamic markers or clinical response parameters will ... | [] |
NCT01296932 | 2.3 | BENEFIT - RISK ASSESSMENT | 2.3 BENEFIT - RISK ASSESSMENT Although considerable progress has been achieved in understanding the aetiology and biologic behaviour of CLL and the development of more effective treatment regimens, most patients with advanced or refractory CLL may eventually not be amenable to established forms of treatment. In particu... | [] |
NCT01296932 | 3 | DESCRIPTION OF DESIGN AND TRIAL POPULATION | 3. DESCRIPTION OF DESIGN AND TRIAL POPULATION | [] |
NCT01296932 | 3.1 | OVERALL TRIAL DESIGN AND PLAN | 3.1 OVERALL TRIAL DESIGN AND PLAN This trial will be performed in patients suffering from advanced or refractory chronic lymphocytic leukemia (CLL) who have failed two prior lines of therapy. It will be performed in an open, non-randomized, modified 3+3 design. Initially, patients will be treated at escalating dose lev... | [] |
NCT01296932 | 3.1.1 | Administrative structure of the trial | 3.1.1 Administrative structure of the trial Boehringer Ingelheim is the Sponsor of this trial. The Coordinating Investigator and participating investigators will be physicians experienced and specialized in the treatment of CLL and in the conduct of phase I trials. A Data Safety Monitoring Board (DSMB) will perform reg... | [] |
NCT01296932 | 3.2 | DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUP | 3.2 DISCUSSION OF TRIAL DESIGN, INCLUDING THE CHOICE OF CONTROL GROUP The primary objective of this trial is to determine the MTD. The most important secondary objective is to assess the safety of BI 836826. This can be achieved by an open label, single arm trial design without a control group. Adult patients with CLL ... | [] |
NCT01296932 | 3.3 | SELECTION OF TRIAL POPULATION | 3.3 SELECTION OF TRIAL POPULATION | [] |
NCT01296932 | 3.3.1 | Main diagnosis for study entry | 3.3.1 Main diagnosis for study entry Patients with chronic lymphocytic leukaemia will be eligible for this trial. | [] |
NCT01296932 | 3.3.2 | Inclusion criteria | 3.3.2 Inclusion criteria - 1. Diagnosis of relapsed or refractory chronic lymphocytic leukaemia (according to the definition of the IWCLL ([R10-4429\)](#page-68-0)) - 2. Previous therapy of CLL with at least two prior treatment regimens - 3. At least one of the following criteria for active disease as defined by the IW... | [] |
NCT01296932 | 3.3.3 | Exclusion criteria | 3.3.3 Exclusion criteria - 1. Prior treatment with anti CD 20 therapy within 4 weeks, or alemtuzumab within 8 weeks, or any cytotoxic antileukemia therapy within 2 weeks, Ibrutinib or Idelalisib within 1 week prior to the first administration of the trial drug - 2. Prior allogeneic stem cell transplantation - 3. Active... | [] |
NCT01296932 | 3.3.4 | Removal of patients from therapy or assessments | 3.3.4 Removal of patients from therapy or assessments | [] |
NCT01296932 | 3.3.4.1 | Removal of individual patients | 3.3.4.1 Removal of individual patients An individual patient is to be withdrawn from the trial if: - The patient withdraws consent. Patients are free to discontinue their participation in this trial at any time without the need to justify the decision. - The patient needs concomitant drugs which may interfere with the ... | [] |
NCT01296932 | 3.3.4.2 | Discontinuation of the trial by the sponsor | 3.3.4.2 Discontinuation of the trial by the sponsor Boehringer Ingelheim reserves the right to discontinue the trial overall or at a particular trial site at any time for the following reasons: - 1. Violation of GCP, the CTP, or the contract by a trial site or investigator, disturbing the appropriate conduct of the tri... | [] |
NCT01296932 | 3.3.4.2.1 | Trial stopping rules in case of unacceptable toxicities | 3.3.4.2.1 Trial stopping rules in case of unacceptable toxicities All AEs, including SAEs and deaths will be carefully analyzed by the sponsor. Unacceptable toxicity will be defined as: - Clinically relevant adverse events that are unexpected considering the mode of action, and are not manifestations of underlying dise... | [] |
NCT01296932 | 4 | TREATMENTS | 4. TREATMENTS | [] |
NCT01296932 | 4.1 | TREATMENTS TO BE ADMINISTERED | 4.1 TREATMENTS TO BE ADMINISTERED In course 1, the total dose will be divided into two portions administered on day 1 and 2 (please refer to the [Flow Chart:](#page-5-0) Course 1, Dosing on Day 1 and Day 2). The dose on day 1 will be 10% of the total dose, but not exceed 10 mg in case the total dose is higher than 100 ... | [] |
NCT01296932 | 4.1.1 | Identity of BI investigational product and comparator product(s) | 4.1.1 Identity of BI investigational product and comparator product(s) 4.1.1.1 BI 836826 Substance (INN): BI 836826 Pharmaceutical form: Solution for infusion after dilution Source: Boehringer Ingelheim Pharma GmbH & Co. KG Unit strength: 10 mg/mL (vials with 10 mL) Daily dose: See [Section 4.1.3](#page-28-0) Duration ... | [] |
NCT01296932 | 4.1.2 | Method of assigning patients to treatment groups | 4.1.2 Method of assigning patients to treatment groups Not applicable. This is a single arm, open-label, dose escalation trial. | [] |
NCT01296932 | 4.1.3 | Selection of doses in the trial | 4.1.3 Selection of doses in the trial BI 836826 will be administered as a rate-controlled, intravenous infusion on day 1, 2 and possibly day 8 in course 1 and on day 1 in the subsequent courses. A fixed dose of 1 mg BI 836826 per patient was determined to be the safe first in human starting dose for patients with an ad... | [] |
NCT01296932 | 4.1.4 | Drug assignment and administration of doses for each patient | 4.1.4 Drug assignment and administration of doses for each patient Prior to inclusion of a new patient during the dose escalation phase the investigator has to confirm the actual dose tier of BI 836826 for the patient with the Clinical Monitor of the sponsor who oversees the dose escalation steps and the safety data of... | [] |
NCT01296932 | 4.1.5 | Blinding and procedures for unblinding | 4.1.5 Blinding and procedures for unblinding | [] |
NCT01296932 | 4.1.5.1 | Blinding | 4.1.5.1 Blinding This phase I trial will be performed according to an open, single arm design. It will recruit patients with relapsed and refractory CLL and active disease. This open-label trial will be handled in an open fashion by the sponsor throughout, i.e. also for the purpose of data cleaning and preparation of t... | [] |
NCT01296932 | 4.1.5.2 | Procedures for emergency unblinding | 4.1.5.2 Procedures for emergency unblinding Not applicable. | [] |
NCT01296932 | 4.1.6 | Packaging, labelling, and re-supply | 4.1.6 Packaging, labelling, and re-supply For details of packaging and the description of the label, refer to the Investigator Site File (ISF). Medication will be delivered to the investigator's pharmacy where the total dose per patient will be prepared upon request from the investigator. For preparation of the BI 8368... | [] |
NCT01296932 | 4.1.7 | Storage conditions | 4.1.7 Storage conditions BI 836826 has to be stored in a limited access area at the temperature indicated on the trial drug label. If the storage conditions are found to be outside the specified range, immediately contact the local clinical monitor or the CRA as provided in the list of contacts. For more details on BI ... | [] |
NCT01296932 | 4.1.8 | Drug accountability | 4.1.8 Drug accountability Drug supplies, which will be provided by the sponsor or a CRO appointed by the sponsor, must be kept in a secure, limited access storage area under the storage conditions defined by the sponsor. A temperature log must be maintained to make certain that the drug supplies are stored at the corre... | [] |
NCT01296932 | 4.2 | CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE TREATMENT | 4.2 CONCOMITANT THERAPY, RESTRICTIONS, AND RESCUE TREATMENT | [] |
NCT01296932 | 4.2.1 | Rescue medication, emergency procedures, and additional treatments | 4.2.1 Rescue medication, emergency procedures, and additional treatments Rescue medication to reverse the action of BI 836826 is not available. Potential side effects of BI 836826 have to be treated symptomatically. Patients should receive supportive care according to local guidelines regarding treatment of infusion-re... | [] |
NCT01296932 | 4.2.2 | Restrictions | 4.2.2 Restrictions | [] |
NCT01296932 | 4.2.2.1 | Restrictions regarding concomitant treatment | 4.2.2.1 Restrictions regarding concomitant treatment Prior antileukemia therapy must have been discontinued in line with the requirement per exclusion criterion 1 and the patient must have recovered from all clinically relevant reversible toxicities. A time interval of at least 4 weeks must have elapsed from the last a... | [] |
NCT01296932 | 4.2.2.2 | Restrictions on diet and life style | 4.2.2.2 Restrictions on diet and life style No restrictions apply with regard to diet or life style. | [] |
NCT01296932 | 4.3 | TREATMENT COMPLIANCE | 4.3 TREATMENT COMPLIANCE | BI 836826 will be administered as a single intravenous infusion under supervision of the | |------------------------------------------------------------------------------------------| | investigator or dedicated clinic personnel. | | Any discrepancies will be explained in the CRF by the | | i... | [] |
NCT01296932 | 5 | VARIABLES AND THEIR ASSESSMENT | 5. VARIABLES AND THEIR ASSESSMENT | [] |
NCT01296932 | 5.1 | EFFICACY - PHARMACODYNAMICS | 5.1 EFFICACY - PHARMACODYNAMICS | [] |
NCT01296932 | 5.1.1 | Endpoints of efficacy | 5.1.1 Endpoints of efficacy The efficacy endpoints will be assessed at the time points specified in the [Flow Chart](#page-5-0). Efficacy endpoints will be secondary or further endpoints in this trial. Secondary endpoints of efficacy are: - Number of lymphocytes in the peripheral blood - Blood counts (red blood cells, ... | [] |
NCT01296932 | 5.1.2 | Assessment of efficacy | 5.1.2 Assessment of efficacy | [] |
NCT01296932 | 5.1.2.1 | Number of lymphocytes in the peripheral blood | 5.1.2.1 Number of lymphocytes in the peripheral blood In most patients with relapsed or refractory CLL, malignant B-cells represent the majority of lymphocytes in the peripheral blood. Reduction of B-cells can be assessed in the peripheral blood by blood cell counts, differential WBC analysis and flow cytometry, which ... | [] |
NCT01296932 | 5.1.2.4 | Assessment and definition of overall best response | 5.1.2.4 Assessment and definition of overall best response Response will be assessed according to the IWCLL guidelines based on laboratory data from the peripheral blood and clinical examination after each course prior to administration of the next dose of BI 836826, at the EOT-visit and at all follow-up visits. Bone m... | [] |
NCT01296932 | 5.1.2.4.1 | Complete remission (CR) | 5.1.2.4.1 Complete remission (CR) CR requires all of the following criteria for a period of at least 2 months: - A1 Peripheral blood lymphocytes (evaluated by WBC and differential count) below 4 x 109 /L. - A2 Absence of significant lymphadenopathy, i.e. no lymph nodes > 1.5 cm. - A3 No hepatomegaly. - A4 No splenomega... | [] |
NCT01296932 | 5.1.2.4.2 | Nodular partial remission (nodular PR) | 5.1.2.4.2 Nodular partial remission (nodular PR) In case lymphoid nodules are found in the bone marrow, but all other criteria for CR are met, the case should be classified as nodular PR | [] |
NCT01296932 | 5.1.2.4.3 | Partial remission (PR) | 5.1.2.4.3 Partial remission (PR) To define a PR, at least 2 criteria of category A and 1 criterion of category B have to be met for a period of at least 2 months. - A1 Decrease in the number of blood lymphocytes by 50% or more compared to the pretreatment value. - A2 Reduction in lymphadenopathy by 50% or more, defined... | [] |
NCT01296932 | 5.1.2.4.4 | Progressive disease (PD) | 5.1.2.4.4 Progressive disease (PD) At least one of the following criteria is required: - A1 An increase in the number of blood lymphocytes by 50% or more over baseline with an absolute number of B-lymphocytes of at least 5 x 109 /L. - A2 Progression of lymphadenopathy, defined as appearance of any new lymph node > 1.5 ... | [] |
NCT01296932 | 5.1.2.4.5 | Stable disease (SD) | 5.1.2.4.5 Stable disease (SD) Patients who have not achieved a CR or a PR, and who have not exhibited PD, will be considered to have stable disease. | [] |
NCT01296932 | 5.1.2.5 | Progression free survival (PFS) | 5.1.2.5 Progression free survival (PFS) PFS is defined as the time from first treatment with BI 836826 until disease progression or death. | [] |
NCT01296932 | 5.1.2.6 | Failure free survival (FFS) | 5.1.2.6 Failure free survival (FFS) Some patients will receive the next line of therapy, although no formal PD may be diagnosed at the time when the next treatment is indicated according to investigator assessment. In addition to PFS, the FFS will be calculated to assess this group of patients. FFS is defined as the ti... | [] |
NCT01296932 | 5.2 | SAFETY | 5.2 SAFETY | [] |
NCT01296932 | 5.2.1 | Endpoints of safety | 5.2.1 Endpoints of safety As this trial is the first in human use of BI 836826, the primary objective is to assess the safety of the drug in humans and to determine the MTD of BI 836826. For details on determination of MTD, please refer to [Sections 3.1](#page-21-0), [5.2.1.1](#page-38-0) and [7.3.1](#page-59-0). The s... | [] |
NCT01296932 | 5.2.1.1 | Dose limiting toxicity (DLT) | 5.2.1.1 Dose limiting toxicity (DLT) DLT is defined as any drug-related non-haematological adverse event CTCAE grade 3 or higher, except infusion related reactions associated with the administration of BI 836826. The additional following haematologic adverse events will be considered DLT: - o Grade 4 neutropenia lastin... | [] |
NCT01296932 | 5.2.2 | Assessment of adverse events | 5.2.2 Assessment of adverse events | [] |
NCT01296932 | 5.2.2.1 | Definitions of adverse events | 5.2.2.1 Definitions of adverse events
Adverse event An adverse event (AE) is defined as any untoward medical occurrence, including an exacerbation of a pre-existing condition, in a patient in a clinical investigation who received a pharmaceutical product. The event does not necessarily have to have a causal relationsh... | [
"Adverse event",
"Protocol-specified significant adverse event",
"Serious adverse event",
"Intensity of adverse event",
"Causal relationship of adverse event",
"Worsening of underlying disease or other pre-existing conditions",
"Changes in vital signs, ECG, physical examination, and laboratory test resu... |
NCT01296932 | 5.2.2.2 | Adverse event and serious adverse event reporting | 5.2.2.2 Adverse event and serious adverse event reporting Upon inclusion into a trial, the patient's condition is assessed (e.g. documentation of medical history/concomitant diagnoses and diseases), and relevant changes from baseline are noted subsequently. All adverse events, serious and non-serious, occurring during ... | [
"Pregnancy"
] |
NCT01296932 | 5.2.3 | Assessment of safety laboratory parameters | 5.2.3 Assessment of safety laboratory parameters | [] |
NCT01296932 | 5.2.3.1 | General safety laboratory parameters | 5.2.3.1 General safety laboratory parameters Blood samples and urine have to be collected at the time points specified in the [Flow Chart](#page-5-0). Blood samples should be collected more frequently in case of relevant toxicities; e.g. in case of grade 4 neutropenia or thrombocytopenia, to document as accurately as p... | [] |
NCT01296932 | 5.2.3.2 | Screening for laboratory evidence of tumour lysis syndrome | 5.2.3.2 Screening for laboratory evidence of tumour lysis syndrome Tumor lysis syndrome (TLS) is characterized by a group of metabolic derangements caused by the massive and abrupt release of cellular components into the blood after rapid lysis of malignant cells. The release of intracellular metabolites, including nuc... | [] |
NCT01296932 | 5.2.3.3 | Virology | 5.2.3.3 Virology | [] |
NCT01296932 | 5.2.3.3.1 | Screening for hepatitis B, hepatitis C, cytomegalovirus and human immunodeficiency virus | 5.2.3.3.1 Screening for hepatitis B, hepatitis C, cytomegalovirus and human immunodeficiency virus Patients with active hepatitis B (HBV), hepatitis C (HCV) or laboratory evidence of a chronic infection have to be excluded from the trial. The same applies to patients with a human immunodeficiency virus (HIV) infection.... | [] |
NCT01296932 | 5.2.3.3.2 | CMV monitoring | 5.2.3.3.2 CMV monitoring Monitoring of CMV has to be performed at the time points indicated in the [Flow Chart](#page-5-0) according to local standards. Quantitative PCR assays to detect CMV DNA and quantitative assays of the pp65 antigen are considered acceptable for the purpose of this trial. The same method should b... | [] |
NCT01296932 | 5.2.4 | Electrocardiogram | 5.2.4 Electrocardiogram A 12-lead resting ECG will be performed in all patients at the screening visit and at the EOT visit. The ECG will be assessed for pathological results (to be recorded as either concomitant disease or AE) by the investigator. Additional examinations should be done whenever the investigator deems ... | [] |
NCT01296932 | 5.2.5 | Assessment of other safety parameters | 5.2.5 Assessment of other safety parameters | [] |
NCT01296932 | 5.2.5.1 | Vital signs | 5.2.5.1 Vital signs Vital signs (blood pressure, pulse rate and body temperature) will be recorded at every visit during screening, treatment and follow-up. Additional time points for blood pressure and heart rate at the day of administration of BI 836826 are: prior to the start of premedication and infusion, then ever... | [] |
NCT01296932 | 5.2.5.2 | Physical examination | 5.2.5.2 Physical examination A physical examination including weight and ECOG performance score will be performed at screening and at the time points specified in the [Flow Chart.](#page-5-0) During the physical examination, the patient should be assessed for possible adverse events.  ![](page47... | [] |
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