Trial · NCT04599634
Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies
NCT04599634, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2025-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies. Trials, record NCT04599634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04599634
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies
- NCT number
- NCT04599634
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 11 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Follicular Lymphoma, Marginal Zone Lymphoma, Mantle Cell Lymphoma, Chronic Lymphocytic Lymphoma, B-Cell Lymphoma
- Interventions
Obinutuzumab, Venetoclax, Magrolimab, Acetaminophen, Diphenhydramine, Prednisone/prednisolone, Methylprednisolone, CT Scan chest/abdomen/pelvis, MRI, 18-FDG-PET, Bone Marrow Biopsy, Bone Marrow Aspiration
- First posted
- 2020-10-23
- Last updated
- 2025-02-04
- Results first posted
- 2025-02-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | 4 weeks for Arm 1 and 5 weeks for Arm 2 | Incidence of dose limiting toxicities (i.e., grade and frequency) to determine safety and tolerability were measured by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade is 3 is severe. Grade 4 is life threatening, and Grade 5 is death related to adverse event. A DLT is defined as any grade 3 or higher adverse event that is clinically relevant and deemed probably or definitely related to any of the study drugs or to the combination therapy and occurs during the venetoclax dose-finding period. Exceptions are non-hematologic grade 3 nausea, vomiting or diarrhea. Grade 3 fatigue, electrolyte disturbances, magrolimab or obinutuzumab infusion reactions, and/or grade 3 laboratory abnormalities. Hematologic grade 3 neutropenia, thrombocytopenia, anemia and hemolytic anemia. And/or grade 3 or 4 lymphopenia. |
| Secondary | Overall Response Rate (ORR) (Complete Response + Partial Response) | From the start of the treatment until disease progression/recurrence, median follow-up of 17.4 months | ORR was determined and reported from individual cohorts and histological diagnosis. ORR was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Complete response is complete resolution of the lesion on imaging. Partial response is 50% or greater reduction in the maximum diameter of the lesion from its original tumor size on imaging. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm. |
| Secondary | Duration of Response (DOR) | From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 10.9 months. | DOR was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. DOR was measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, death, or, in the absence of progressive disease (PD), date of last assessment. DOR was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Complete response is complete resolution of the lesion on imaging. Partial response is 50% or greater reduction in the maximum diameter of the lesion from its original tumor size on imaging. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm. |
| Secondary | Event-free Survival (EFS) | From the start of the treatment until time of disease relapse, disease progression, alternative anti-lymphoma therapy including radiation, or death, whichever occurs first, up to 20 months | EFS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative anti-lymphoma therapy including radiation, or death, whichever occurs first, measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm. |
| Secondary | Progression-free Survival | From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 13.9 months. | PFS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. PFS was measured by the Lugano response criteria for Follicular Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma; and the International Workshop on Chronic Lymphocytic Leukemia criteria for Chronic Lymphocytic Leukemia. Disease progression is an increase of 50% or more in size of a previously involved site measuring ≥1.5 cm. |
| Secondary | Overall Survival (OS) | From the start of the treatment until death from any cause, an average of 15.6 months. | OS was estimated using Kaplan-Meier curves and reported along with a 95% confidence interval. OS is defined as the time from study enrollment until death from any cause. |
| Secondary | Percentage of Participants With Chronic Lymphocytic Leukemia (CLL) With Complete Molecular Remission (MRD Negativity) | From the start of the treatment until disease progression/recurrence, an average of 3.3 months. | The percentage of participants who are MRD negative was determined by circulating tumor deoxyribonucleic acid (ctDNA) assay after therapy. Negative is undetectable CLL cells on peripheral blood flow cytometry after end of treatment. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | From the first study intervention, Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | 4 weeks for Arm 1 and 5 weeks for Arm 2 | Adverse events | NUMBER | |
| SECONDARY | Overall Response Rate (ORR) (Complete Response + Partial Response) | From the start of the treatment until disease progression/recurrence, median follow-up of 17.4 months | Percentage of participants | NUMBER | |
| SECONDARY | Duration of Response (DOR) | From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 10.9 months. | Months | MEDIAN | |
| SECONDARY | Event-free Survival (EFS) | From the start of the treatment until time of disease relapse, disease progression, alternative anti-lymphoma therapy including radiation, or death, whichever occurs first, up to 20 months | Months | MEDIAN | |
| SECONDARY | Progression-free Survival | From the start of the treatment until time of disease relapse, disease progression, or death, whichever occurs first, an average of 13.9 months. | Months | MEDIAN | |
| SECONDARY | Overall Survival (OS) | From the start of the treatment until death from any cause, an average of 15.6 months. | Months | MEDIAN | |
| SECONDARY | Percentage of Participants With Chronic Lymphocytic Leukemia (CLL) With Complete Molecular Remission (MRD Negativity) | From the start of the treatment until disease progression/recurrence, an average of 3.3 months. | This outcome measure is applicable to participants with CLL only. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | From the first study intervention, Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | Grade 4 Thrombocytopenia Definitely Related | 0 | Adverse events | |
| Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | Grade 4 Thrombocytopenia Definitely Related | 2 | Adverse events | |
| Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | Grade 3 and 5 Probably and/or Definitely Related Toxicity | 0 | Adverse events | |
| Number of Grades 3, 4, and/or 5 Dose-limiting Toxicities (DLT) Probably and/or Definitely Related to Triplet Combination Therapy | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | Grade 3 and 5 Probably and/or Definitely Related Toxicity | 0 | Adverse events | |
| Overall Response Rate (ORR) (Complete Response + Partial Response) | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | Complete Response | 40 | 95% Confidence Interval 7.1 to 76.9 | Percentage of participants |
| Overall Response Rate (ORR) (Complete Response + Partial Response) | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | Complete Response | 66.7 | 95% Confidence Interval 30.0 to 94.1 | Percentage of participants |
| Overall Response Rate (ORR) (Complete Response + Partial Response) | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | Partial Response | 40 | 95% Confidence Interval 7.1 to 76.9 | Percentage of participants |
| Overall Response Rate (ORR) (Complete Response + Partial Response) | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | Partial Response | 16.7 | 95% Confidence Interval 0.9 to 56.4 | Percentage of participants |
| Duration of Response (DOR) | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 17.5 | 95% Confidence Interval 2.8 to NA | Months | |
| Duration of Response (DOR) | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | NA | 95% Confidence Interval NA to NA | Months |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental Treatment: Follicular Lymphoma Dose Expansion | 0 | |
| Overall Study | STARTED | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 5 | |
| Overall Study | STARTED | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 6 | |
| Overall Study | STARTED | Experimental Treatment: Chronic Lymphocytic Leukemia Dose Expansion | 0 | |
| Overall Study | Off Study- Study is Cancelled | Experimental Treatment: Follicular Lymphoma Dose Expansion | 0 | |
| Overall Study | Off Study- Study is Cancelled | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 5 | |
| Overall Study | Off Study- Study is Cancelled | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 6 | |
| Overall Study | Off Study- Study is Cancelled | Experimental Treatment: Chronic Lymphocytic Leukemia Dose Expansion | 0 | |
| Overall Study | COMPLETED | Experimental Treatment: Follicular Lymphoma Dose Expansion | 0 | |
| Overall Study | COMPLETED | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 5 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events58
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 | Back pain | Musculoskeletal and connective tissue disorders | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 0 | 5 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 1 | 6 | 1 |
| other | Bruising | Injury, poisoning and procedural complications | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 1 | 5 | 1 |
| other | Bruising | Injury, poisoning and procedural complications | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 0 | 6 | 0 |
| other | Chills | General disorders | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 1 | 5 | 1 |
| other | Chills | General disorders | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 0 | 6 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 1 | 5 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 0 | 6 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 2 | 5 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 3 | 6 | 3 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 0 | 5 |
| Total, all-cause mortality | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 0 | 6 |
| Total, other adverse events | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 5 | 5 |
| Total, other adverse events | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 5 | 6 |
| Total, serious adverse events | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | 1 | 5 |
| Total, serious adverse events | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 1 | 6 |
Source ClinicalTrials.gov
Papers0
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Arm 1, Cohort 1 Follicular Lymphoma Level 1 vs Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Arm 1, Cohort 1 Follicular Lymphoma Level 1 vs Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1: deaths from any cause | Trial comparisons |
| Arm 1, Cohort 1 Follicular Lymphoma Level 1 vs Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1: serious adverse events | Trial comparisons |
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/NCT04599634
GET https://conductscience.org/api/trials/v1/NCT04599634/events?page=2