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NCT03710772 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma
A Phase 2 study of Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT03710772: Active Phase 2 study of Mantle Cell Lymphoma, sponsored by M.D. Anderson Cancer Center.
NCT03710772 is a Phase 2 study of Mantle Cell Lymphoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 51 participants, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03710772, a Phase 2 study of Mantle Cell Lymphoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well ibrutinib and rituximab given together with venetoclax and combination chemotherapy work in treating patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Drugs used in chemotherapy such as, cyclophosphamide, vincristine, doxorubicin, and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib, rituximab, and venetoclax together with combination chemotherapy may work better in treating patients with mantle cell lymphoma.
Primary Outcome
Determined by complete response (CR). The complete response after 4 cycles of venetoclax combined with ibrutinib plus rituximab and toxicity within first cycle of venetoclax combination will be monitored simultaneously using the Bayesian stopping boundaries calculated based on beta-binomial distributions. The prior probabilities of response and toxicity are modeled by beta distributions. Complete response and its 95% confidence interval will be calculated. Logistic regression will be utilized to
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Dexamethasone
- DRUG Cytarabine
- DRUG Ibrutinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2027-03-22 |
| Phase | Phase 2 |
What the registry record for NCT03710772 still lists
NCT03710772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 104-participant average among 102 other Mantle Cell Lymphoma trials with a reported enrollment target (51% lower).
The record links to 1 condition, with Mantle Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03710772 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03710772 about?
NCT03710772 is a clinical study titled "Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma". This phase II trial studies how well ibrutinib and rituximab given together with venetoclax and combination chemotherapy work in treating patients with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Rituximab...
What is the current status of trial NCT03710772?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2019-05-01. Estimated completion is 2027-03-22.
What conditions does trial NCT03710772 study?
This clinical trial studies the following conditions: Mantle Cell Lymphoma.
What interventions are being tested in trial NCT03710772?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Dexamethasone (DRUG), Cytarabine (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03710772?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03710772 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mantle Cell Lymphoma
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 NCT03710772's enrollment target sits among peer trials
51 42nd of 102 higher than 61 of 102 other Mantle Cell Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mantle Cell Lymphoma 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
-
Nemtabrutinib With Rituximab for the Treatment of Patients With Mantle Cell Lymphoma
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Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
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Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients
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Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients
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