Trial · NCT02564744
Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL
NCT02564744, Phase 2, Completed, Debiopharm International SA; results first posted 2024-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL. Trials, record NCT02564744. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02564744
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL
- NCT number
- NCT02564744
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Debiopharm International SA
- Conditions
- Diffuse Large B-Cell Lymphoma, B-cell Non-Hodgkin's Lymphoma
- Interventions
- Debio 1562, Rituximab
- First posted
- 2015-10-01
- Last updated
- 2024-06-12
- Other registries' IDs
- eudract:2015-004061-87
- Results first posted
- 2024-05-17
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Up to 30 days after end of treatment (EOT) (Up to 38 months) | An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included exacerbation of a pre-existing condition. AEs included worsening (change in nature, severity, or frequency) of conditions present at the onset of the study, intercurrent illnesses, drug interactions, events related to or possibly related to concomitant medications, abnormal laboratory values (this included significant shifts from baseline within the range of normal that the Investigator considered to be clinically important), clinically significant abnormalities in physical examination, vital signs, and weight. |
| 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) | The clinical laboratory tests included Hematology: Hematocrit (Hct), hemoglobin (Hgb), platelet count, red blood cell (RBC) count, white blood cell (WBC) count with differential; Serum Chemistry: Albumin (ALB), alkaline phosphatase (ALK-P), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), calcium (Ca), chloride (Cl), creatinine, glucose, lactate dehydrogenase (LDH), magnesium, phosphorus, potassium (K), sodium (Na), total bilirubin, total protein, uric acid, immunoglobulin levels (IgG, IgA, IgM); Urinalysis: Appearance, specific gravity and pH, evaluation of glucose, protein, bilirubin, ketones, leukocytes and blood; Coagulation: Prothrombin time (PT) or international normalized ratio (INR), activated partial thromboplastin time (aPTT). |
| Primary | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as TEAEs | Up to 30 days after EOT (Up to 38 months) | A standard 12-lead ECG was performed. |
| 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) | Vital signs included systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate. |
| 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 | ORR was defined as the percentage of participants with a Best overall response (BOR) of partial response (PR) or complete response (CR). BOR was the best response recorded from the start of the treatment until disease progression, initiation of new anti-cancer therapy, or end of the study period, whichever occurred first. CR was defined as disappearance of all target lesions, no new lesions formation. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤1.5 cm. PR was defined as ≥50% decrease in the sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation. |
| 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) | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group327
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1: Safety Run-in | 16 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1: Cohort 1 | 8 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 1: Cohort 2 | 12 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 2/3: Cohort A | 32 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Part 2/3: Cohort B | 29 | Participants | ||
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Part 1: Safety Run-in | Neutrophil Count Decreased | 6 | Participants | |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Part 1: Cohort 1 | Neutrophil Count Decreased | 1 | Participants | |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Part 1: Cohort 2 | Neutrophil Count Decreased | 2 | Participants | |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Part 2/3: Cohort A | Neutrophil Count Decreased | 2 | Participants | |
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Test Results Reported as TEAEs | Part 2/3: Cohort B | Neutrophil Count Decreased | 2 | Participants |
1 to 10 of 327Source ClinicalTrials.gov
See all 327 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Part 1: Safety Run-in | 17 | |
| Overall Study | STARTED | Part 1: Cohort 1 | 8 | |
| Overall Study | STARTED | Part 1: Cohort 2 | 12 | |
| Overall Study | STARTED | Part 2/3: Cohort A | 33 | |
| Overall Study | STARTED | Part 2/3: Cohort B | 30 | |
| Overall Study | Efficacy Evaluable (EE) Population | Part 1: Safety Run-in | 15 | |
| Overall Study | Efficacy Evaluable (EE) Population | Part 1: Cohort 1 | 8 | |
| Overall Study | Efficacy Evaluable (EE) Population | Part 1: Cohort 2 | 11 | |
| Overall Study | Efficacy Evaluable (EE) Population | Part 2/3: Cohort A | 30 | |
| Overall Study | Efficacy Evaluable (EE) Population | Part 2/3: Cohort B | 30 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events1,100
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypertension | Vascular disorders | Part 1: Safety Run-in | 0 | 17 | |
| other | Hypertension | Vascular disorders | Part 1: Cohort 1 | 0 | 8 | |
| other | Hypertension | Vascular disorders | Part 1: Cohort 2 | 0 | 12 | |
| other | Hypertension | Vascular disorders | Part 2/3: Cohort A | 3 | 33 | |
| other | Hypertension | Vascular disorders | Part 2/3: Cohort B | 2 | 30 | |
| other | Flushing | Vascular disorders | Part 1: Safety Run-in | 0 | 17 | |
| other | Flushing | Vascular disorders | Part 1: Cohort 1 | 0 | 8 | |
| other | Flushing | Vascular disorders | Part 1: Cohort 2 | 2 | 12 | |
| other | Flushing | Vascular disorders | Part 2/3: Cohort A | 1 | 33 | |
| other | Flushing | Vascular disorders | Part 2/3: Cohort B | 0 | 30 |
1 to 10 of 1,100Source ClinicalTrials.gov
See all 1,100 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Safety Run-in | 11 | 17 |
| Total, all-cause mortality | Part 1: Cohort 1 | 6 | 8 |
| Total, all-cause mortality | Part 1: Cohort 2 | 5 | 12 |
| Total, all-cause mortality | Part 2/3: Cohort A | 16 | 33 |
| Total, all-cause mortality | Part 2/3: Cohort B | 17 | 30 |
| Total, other adverse events | Part 1: Safety Run-in | 15 | 17 |
| Total, other adverse events | Part 1: Cohort 1 | 8 | 8 |
| Total, other adverse events | Part 1: Cohort 2 | 12 | 12 |
| Total, other adverse events | Part 2/3: Cohort A | 32 | 33 |
| Total, other adverse events | Part 2/3: Cohort B | 29 | 30 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02564744
GET https://conductscience.org/api/trials/v1/NCT02564744/results?page=2