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NCT03121534 · ClinicalTrials.gov registry record · Phase 2
Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03121534: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT03121534 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03121534, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if blinatumomab can help to control Richter Transformation (RT, a type of blood cancer). The safety of this drug will also be studied. This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of acute lymphoblastic leukemia (ALL). It is investigational to use blinatumomab to treat patients with RT. The study doctor can explain how the study drug is designed to work. Up to 21 participants will be enrolled in this study. All will take part at MD Anderson.
Primary Outcome
Response is defined as complete remission (CR) plus partial remission (PR). Complete Remission (CR) is Lymph nodes None \>/= 1.5 cm, Spleen size \< 13 cm; normal liver size, the absence of constitutional symptoms, normal circulating lymphocyte count, platelets \>/= 100 x 10\^9/L, Hemoglobin \>/= 11.0 g/dL (absence of transfusion and without erythropoietin) and marrow normocellular, no CLL cells and no B-lymphoid nodules. Partial Remission (PR) is any two of the following must decrease \>/= 50% f
Interventions
- DRUG Nivolumab
- DRUG Dexamethasone
- DRUG Blinatumomab
- DRUG Ibrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-06-22 |
| Est. Completion | 2022-02-11 |
| Phase | Phase 2 |
Why NCT03121534 stopped before completion
NCT03121534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT03121534 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03121534 about?
NCT03121534 is a clinical study titled "Ibrutinib, Nivolumab and Blinatumomab in Richter Transformation". The goal of this clinical research study is to learn if blinatumomab can help to control Richter Transformation (RT, a type of blood cancer). The safety of this drug will also be studied. This is an investigational study. Blinatumomab is FDA approved and commercially available for the treatment of ...
What is the current status of trial NCT03121534?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-06-22. Estimated completion is 2022-02-11.
What interventions are being tested in trial NCT03121534?
The interventions under investigation include: Nivolumab (DRUG), Dexamethasone (DRUG), Blinatumomab (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT03121534?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03121534's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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
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