Trial · NCT02564744
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 30 days after end of treatment (EOT) (Up to 38 months) | Safety population included all participants from the screened population who received at least one dose of Debio 1562. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Up to 30 days after EOT (Up to 38 months) | Safety population includes all participants from the screened population who received at least one dose of Debio 1562. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs | Up to 30 days after EOT (Up to 38 months) | Safety population included all participants from the screened population who received at least one dose of Debio 1562. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Sign Measurements Reported as TEAEs | Up to 30 days after EOT (Up to 38 months) | Safety population included all participants from the screened population who received at least one dose of Debio 1562. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Objective Response Rate (ORR) | Up to Progressive Disease (PD) or death (up to approximately 55 months) or initiation of new anti-cancer therapy whichever occurs first | EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). | percent responders | NUMBER |
| SECONDARY | Maximum Plasma Drug Concentration (Cmax) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre and Post infusion: 5 min-Day (D) 1 of Cycles (C) 1-8 and 2 hours (h)-D1 of C1-2 (for Part 2/3), 24h-D2, 48h-D3 and D8, 15 of C1, 2; D1 of Month 37 (EOT) (rituximab only) and Month 38 (follow-up) (Cycle=21 days) | PK population included all participants who received at least one dose of Debio 1562 or rituximab and had atleast one PK concentration result available. Number analyzed signifies the number of participants with available data at the specific timepoint. | nanogram per milliliter (ng/ml) | MEAN |
| SECONDARY | Area Under the Time-concentration Curve From Time 0 to t (AUC0-t) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Terminal Half-life (t1/2) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Clearance (CL) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Volume of Distribution at Steady State (Vss) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Time to Maximum Plasma Concentration (Tmax) of Debio 1562 and Rituximab | Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up | Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab. | ||
| SECONDARY | Progression-free Survival (PFS) | Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first | EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). | months | MEDIAN |
| SECONDARY | Time to Response (TTR) | Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first | EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded. | months | MEDIAN |
| SECONDARY | Duration of Response (DOR) | Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first | EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to death or end of study (approximately 57 months) or one year from the last participant's first dose | EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). | months | MEDIAN |
| SECONDARY | Number of Participants With Anti-drug Antibodies (ADA) for Debio 1562 | Part 1: Pre-dose on Day 1 of Cycle(C)1 to 8; Part 2/3: Pre-dose on Day 1 of C1 to 6 and on Day 1 of C7 for participants who received treatment beyond C6 (each C=21 days); Parts 1, 2/3: Month 37 (EOT) and Month 38 (30-Day FU visit) (Cycle=21 days) | ADA population included all participants who received at least one dose of Debio 1562 or rituximab and had at least one ADA post exposure result available. Overall number of participants analyzed signifies number of participants with non-missing ADA value at baseline and at least one non-missing post-treatment value. | Participants | COUNT_OF_PARTICIPANTS |
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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