Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03834688 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age
A Phase 2 study, sponsored by PrECOG.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT03834688: Completed Phase 2 study, sponsored by PrECOG.
NCT03834688 is a Phase 2 study that has completed, run by PrECOG. The registered enrollment target is 33 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03834688, a Phase 2 study, has completed, sponsored by PrECOG.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with mantle cell lymphoma. Venetoclax may make the cancer cells sensitive to chemotherapy. This may help to slow down the growth of cancer or may cause cancer cells to die. The purpose of this study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination.
Primary Outcome
Complete Response (CR) was assessed in accordance with the Lugano Classification Criteria using PET/CT scans (at baseline) and PET/CT or CT scans (during follow-up). Based on this criteria, a Deauville score ≤ 3 corresponds to a CR, a score of 4 or 5 and ≥ 50% decrease in the sum of lesion measurements corresponds to a Partial Response (PR), a score of 4 or 5 and \<50% decrease in sum of lesion measurements corresponds to a Stable Disease (SD), a score of 4 or 5 and \>1.5cm increase in a single
Interventions
- DRUG Venetoclax
- DRUG Rituximab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2020-01-13 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 2 |
What the finished NCT03834688 record still lists
NCT03834688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Venetoclax is the first listed.
NCT03834688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03834688 about?
NCT03834688 is a clinical study titled "Phase II Study of Bendamustine and Rituximab Plus Venetoclax in Untreated Mantle Cell Lymphoma Over 60 Years of Age". Eligible untreated patients will receive single arm venetoclax, bendamustine and rituximab as induction therapy. After 6 cycles, maintenance rituximab may be administered per physician discretion. Venetoclax is an oral Bcl-2 family protein inhibitor. It targets the B-cell lymphoma 2 (BCL-2) protein...
What is the current status of trial NCT03834688?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2020-01-13. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT03834688?
The interventions under investigation include: Venetoclax (DRUG), Rituximab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT03834688?
This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03834688's enrollment target sits among peer trials
33 1553rd of 2000 higher than 438 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02861898 · 33 participants · Phase 1
Super-selective Intra-arterial Repeated Infusion of Cetuximab for the Treatment of Newly Diagnosed Glioblastoma
- NCT04871607 · 33 participants · Phase 2
Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma
- NCT05071937 · 33 participants · Phase 2
ZEN003694 Combined With Talazoparib in Patients With Recurrent Ovarian Cancer
- NCT05168618 · 33 participants · Phase 2
Cabozantinib and Atezolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer, The AtezoCab Trial
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI