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NCT04599634 · ClinicalTrials.gov registry record · Phase 1
Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies
A Phase 1 study of Mantle Cell Lymphoma and Follicular Lymphoma, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT04599634 is a Phase 1 study of Mantle Cell Lymphoma and Follicular Lymphoma that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 11 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04599634, a Phase 1 study of Mantle Cell Lymphoma and Follicular Lymphoma, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: B-cell lymphoma is a cancer of certain white blood cells (called lymphocytes). These cells are found in lymph nodes. The cancer can cause enlargement of the lymph nodes leading to pain and discomfort. Swollen lymph nodes can also press on nearby organs such as liver and kidneys which can affect normal functioning of the organs. Researchers think that a new combination of drugs may be able to help. Objective: To find out if it is safe to give the combination of Magrolimab, Obinutuzumab and Venetoclax to people with B-cell lymphomas. Eligibility: Adults age 18 and older with an indolent B-cell lymphoma whose disease has returned or progressed after other treatment. Indolent B-cell lymphoma for this protocol is defined as having either follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma or marginal zone lymphoma. Design: Participants will be screened under a separate protocol. Participants will have 28-day 'cycles' of treatment. They will take Venetoclax by mouth daily. They will get Obinutuzumab and Magrolimab by intravenous (IV) infusion. Treatment will last for about 8 months. They may be able to have more cycles of treatment if their cancer is responding well. Participants will have physical exams, medical histories, and medicine reviews. Data about how they function in their daily activities will be obtained. They will have blood and urine tests. They may have bone marrow tests. Participants will have imaging scans. These will include computed tomography (CT) and/or magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans. Participants may give a cheek swab or saliva sample. They may give tumor tissue and bone marrow samples. These samples may be used for gene testing. Participants will have a follow-up visit about 30 days after treatment ends. Then they will have visits every 3 months for the first 2 years, every 6 months for the next 3 years, and then yearly after t
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Acetaminophen
- DRUG Diphenhydramine
- DRUG Magrolimab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-12-16 |
| Est. Completion | 2024-06-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04599634
The ClinicalTrials.gov registry entry for NCT04599634 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (89% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 5 conditions, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT04599634 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT04599634 about?
NCT04599634 is a clinical study titled "Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies". Background: B-cell lymphoma is a cancer of certain white blood cells (called lymphocytes). These cells are found in lymph nodes. The cancer can cause enlargement of the lymph nodes leading to pain and discomfort. Swollen lymph nodes can also press on nearby organs such as liver and kidneys which ca...
What is the current status of trial NCT04599634?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2021-12-16. Estimated completion is 2024-06-20.
What conditions does trial NCT04599634 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma, Chronic Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04599634?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Acetaminophen (DRUG), Diphenhydramine (DRUG), Magrolimab (DRUG).
Who is sponsoring clinical trial NCT04599634?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04599634 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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