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NCT03960840 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL
A Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
- 20
- Study locations
NCT03960840: Active Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, sponsored by Novartis Pharmaceuticals.
NCT03960840 is a Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 217 participants, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03960840, a Phase 1 study of Chronic Lymphocytic Leukemia and Acute Lymphoblastic Leukemia, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (3L+ DLBCL), adult acute lymphoblastic leukemia (ALL) and 1st Line High Risk Large B-Cell Lymphoma (1L HR LBCL).
Conditions Studied
Interventions
- DRUG Ibrutinib
- BIOLOGICAL Rapcabtagene autoleucel single agent
Study Locations (20)
Other
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Marseille
- Novartis Investigative Site - Paris
- Novartis Investigative Site - Pierre-Bénite
- Novartis Investigative Site - Rennes
California
- University of California LA - Los Angeles
- Stanford University Medical Center - Stanford
Tennessee
- Sarah Cannon Research Institute - Nashville
- Sarah Cannon Research Institute - Nashville
Texas
- St Davids South Austin Medical Ctr - Austin
- Uni Of TX MD Anderson Cancer Cntr - Houston
Victoria
- Novartis Investigative Site - Melbourne
- Novartis Investigative Site - Melbourne
Florida
- H Lee Moffitt Cancer Center and Research Institute - Tampa
Illinois
- Uni of Chi Medi Ctr Hema and Onco - Chicago
Kansas
- University of Kansas Cancer Center - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2019-06-26 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
What the registry record for NCT03960840 still lists
NCT03960840 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 181-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (20% higher).
The record links to 5 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Ibrutinib is the first listed.
NCT03960840 names 20 study sites across 12 states, led by Other, California, Tennessee.
Frequently Asked Questions
What is clinical trial NCT03960840 about?
NCT03960840 is a clinical study titled "Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL". This is a phase I/II study to evaluate the feasibility, safety and preliminary antitumor efficacy of rapcabtagene autoleucel (also known as YTB323). Rapcabtagene autoleucel will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and a...
What is the current status of trial NCT03960840?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2019-06-26. Estimated completion is 2028-05-31.
What conditions does trial NCT03960840 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Small Lymphocytic Lymphoma, Large B-cell Lymphoma.
What interventions are being tested in trial NCT03960840?
The interventions under investigation include: Ibrutinib (DRUG), Rapcabtagene autoleucel single agent (BIOLOGICAL).
Who is sponsoring clinical trial NCT03960840?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03960840 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03960840's enrollment target sits among peer trials
217 41st of 187 higher than 147 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.
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