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NCT04169737 · ClinicalTrials.gov registry record · Phase 2
Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
- 1
- Study location
NCT04169737 is a Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 168 participants, above the 41-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (310% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04169737, a Phase 2 study of Recurrent Chronic Lymphocytic Leukemia and Refractory Chronic Lymphocytic Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Venetoclax may stop the growth cancer cells by blocking BCL-2 protein needed for cell growth. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving acalabrutinib and venetoclax together with early obinutuzumab may improve clinical outcomes and control the disease.
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Acalabrutinib
- BIOLOGICAL Obinutuzumab
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2026-07-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04169737
The ClinicalTrials.gov registry entry for NCT04169737 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 168 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 41-participant average among 20 other Recurrent Chronic Lymphocytic Leukemia trials with a reported enrollment target (310% higher). The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Recurrent Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Venetoclax is the first listed.
NCT04169737 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT04169737 about?
NCT04169737 is a clinical study titled "Acalabrutinib and Venetoclax With or Without Early Obinutuzumab for the Treatment of High Risk, Recurrent, or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase II trial studies how well acalabrutinib and venetoclax with or without early obinutuzumab work for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma that is high risk, has come back (recurrent), or does not respond to treatment (refractory). Acalabrutinib may sto...
What is the current status of trial NCT04169737?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2020-07-29. Estimated completion is 2026-07-09.
What conditions does trial NCT04169737 study?
This clinical trial studies the following conditions: Recurrent Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Recurrent Small Lymphocytic Lymphoma, Refractory Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT04169737?
The interventions under investigation include: Venetoclax (DRUG), Acalabrutinib (DRUG), Obinutuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04169737?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169737 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Recurrent Chronic Lymphocytic Leukemia
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