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NCT03737981 · ClinicalTrials.gov registry record · Phase 3
Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia
A Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 3
- Development phase
- 465
- Enrollment target
- 20
- Study locations
NCT03737981: Active Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by National Cancer Institute (NCI).
NCT03737981 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 465 participants, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (160% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03737981, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 465 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocytic leukemia from returning. This trial also will investigate whether patients who receive ibrutinib plus obinutuzumab plus venetoclax and have no detectable chronic lymphocytic leukemia after 1 year of treatment, can stop taking ibrutinib. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with obinutuzumab may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ibrutinib and obinutuzumab with venetoclax may work better at treating chronic lymphocytic leukemia compared to ibrutinib and obinutuzumab.
Primary Outcome
PFS will be compared between the experimental and control treatment strategy groups using a stratified log-rank test (stratified on Rai stage, intermediate versus \[vs.\] high, and del(17p13.1) by fluorescence in situ hybridization \[FISH\], present vs. absent). The Kaplan-Meier method will be used to estimate PFS distributions. Five-year PFS estimates and corresponding hazard ratios will be provided with 95% confidence intervals for each treatment strategy.
Conditions Studied
Interventions
- DRUG Venetoclax
- BIOLOGICAL Obinutuzumab
- DRUG Ibrutinib
- OTHER Observation Activity
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
- University of Arizona Cancer Center-Orange Grove Campus - Tucson
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- John L McClellan Memorial Veterans Hospital - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2019-01-31 |
| Est. Completion | 2026-12-29 |
| Phase | Phase 3 |
What the registry record for NCT03737981 still lists
NCT03737981 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, above the 179-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (160% higher).
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Venetoclax is the first listed.
NCT03737981 names 20 study sites across 4 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT03737981 about?
NCT03737981 is a clinical study titled "Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia". This phase III trial compares adding a new anti-cancer drug (venetoclax) to the usual treatment (ibrutinib plus obinutuzumab) in older patients with chronic lymphocytic leukemia who have not received previous treatment. The addition of venetoclax to the usual treatment might prevent chronic lymphocy...
What is the current status of trial NCT03737981?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 465 participants. The study started on 2019-01-31. Estimated completion is 2026-12-29.
What conditions does trial NCT03737981 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT03737981?
The interventions under investigation include: Venetoclax (DRUG), Obinutuzumab (BIOLOGICAL), Ibrutinib (DRUG), Observation Activity (OTHER).
Who is sponsoring clinical trial NCT03737981?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03737981 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Lymphocytic Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03737981's enrollment target sits among peer trials
465 23rd of 187 higher than 165 of 187 other Chronic Lymphocytic Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Lymphocytic Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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