Comparison · NCT04599634-05f3433d
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)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 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, record NCT04599634-05f3433d. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04599634-05f3433d
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 1 | 0.566 | 1 | wilson | |
| Risk in group 2 | 0.833 | 0.436 | 0.97 | wilson | |
| Risk difference, group 1 minus group 2 | 0.167 | -0.289 | 0.564 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.839 | 1.72 | log | |
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to treat, for one more participant with the outcome on Arm 1, Cohort 1 Follicular Lymphoma Level 1 than on Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | 6 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Arm 1, Cohort 1 Follicular Lymphoma Level 1 | Magrolimab intravenous (IV) with a 1 mg/kg dose followed by 30mg/kg doses+obinutuzumab IV 1000mg+venetoclax 800mg by mouth combination administered to 6 patients for 6 cycles (28-days each, Cycles 1-6); further treatment with additional cycles will be response-adapted. Note: Dose-limiting toxicity (DLT) assessment of the magrolimab/obinutuzumab/venetoclax triplet will take place during Cycle 1. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 600mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the 1st day for all subsequent cycles at 1000mg for dose finding phase. | 5 | 5 | OG000 |
| Group 2 | Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1 | Magrolimab intravenous (IV) with a 1 mg/kg priming dose followed by 30mg/kg doses + obinutuzumab IV 1000mg + venetoclax ramp-up to target dose of 400mg over 5 weeks (35 days, Cycle 1) administered to 6 patients. Triplet combination of magrolimab + obinutuzumab + venetoclax (target dose, no ramp-up) will continue for five (5) additional cycles (28-days each, Cycles 2-6); further treatment with additional cycles will be response-adapted. If =2 patients experience DLT, an additional 6 patients will be enrolled at Dose level (-1) of venetoclax 200mg with magrolimab and obinutuzumab. Obinutuzumab administered IV, on Days 1, 2, 8 and 15 of Cycle 1 at doses escalating from 100mg - 1000mg then on the first day for all subsequent cycles at 1000mg for dose finding phase. | 5 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
- Description
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.
- Time frame
- From the first study intervention, Day 1 through 30 days after the last dose of study agent was administered, an average of 6 months.
- Population
Source ClinicalTrials.gov
Trial
- Title
- Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies
- NCT number
- NCT04599634
- Phases
- PHASE1
- 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
- Lead sponsor
- National Cancer Institute (NCI)
- Results first posted
- 2025-02-04
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04599634?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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