Trial · NCT02933320
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Documenting Adverse Events (AEs), Serious Adverse Events (SAEs), Dose Limiting Toxicities (DLTs) (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206. | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. | To recommend a dose for future trials with BI-1206 by finding the highest safe dose which can be given to patients. |
| Primary | Documenting AEs, SAEs (Graded According to NCI-CTCAE Version 4.02) and Laboratory Parameters and Determining Their Causality in Relation to BI-1206 and, Where Appropriate, Anti-CD20 Antibody. | Safety data were collected from the date of written informed consent and continued for 125 days after the final administration of BI-1206 or rituximab. | Establishing the MTD or maximum administered dose MAD of BI-1206 and an anti-CD20 antibody given once weekly for four weeks, via intravenous infusion in patients with relapsed or refractory B-cell malignancies. |
| Secondary | Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Maximum observed serum concentration after intravenous BI-1206 administration |
| Secondary | Measurement of PK Parameter Area Under the Serum Concentration-time Curve From Time 0 to the Last Time Point (AUClast) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Area under the serum concentration-time curve from time 0 to the last time point after intravenous BI-1206 administration. |
| Secondary | Measurement of PK Parameter Half-life (T1/2) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | BI-1206 half-life after intravenous administration |
| Secondary | Measurement of PK Parameter Total Body Clearance (CL) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Total body clearance after intravenous BI-1206 administration |
| Secondary | Measurement of PK Parameter Volume of Distribution (Vss) for BI-1206 | Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours) | Volume of distribution after administration of BI-1206 |
| Secondary | Measurement of Anti-drug Antibody (ADA) Response to BI-1206 During the BI-1206 Treatment Period Using ELISA | Pre dose at weeks 1, 5 and 8, maintenance phase and off-study visit. | Patients with true ADA response |
| Secondary | Measurement of Peripheral Blood B-lymphocyte Depletion During the BI-1206 Treatment Period Using Flow Cytometry. | During induction phase (up to 8 weeks). | Number of patients with B-lymphocyte depletion during BI-1206 treatment period. |
| Secondary | Assessment of Best Disease Response According to Criteria for Malignant Lymphoma (Cheson, 2014) Waldenström Macroglobulinaemia Assessment Criteria (Owen 2013, Kimby 2006) or NCI Chronic Lymphocytic Leukaemia (CLL) Criteria (Hallek, 2008). | Response evaluated 4 weeks after last dose in induction phase, every 16 weeks during maintenance phase and at off-study. | To look for signs of anti-tumour activity of BI-1206 alone and in combination in patients with relapsed or refractory B-cell malignancies |
| Secondary | Measure Progression Free Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | From first BI-1206 administration up to 12 months | To measure the time to disease progression and twelve month survival |
| Secondary | Measure Overall Survival at 1 Year After the First BI-1206 Administration on the Study for All Patients | From first BI-1206 administration up to 12 months. Participants whose last reported status was not death were censored. | To measure the time to disease progression and twelve month survival |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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GET https://conductscience.org/api/trials/v1/NCT02933320/registered