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NCT04872790 · ClinicalTrials.gov registry record · Phase 1
Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia
A Phase 1 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, sponsored by OHSU Knight Cancer Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04872790: Recruiting Phase 1 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, sponsored by OHSU Knight Cancer Institute.
NCT04872790 is a Phase 1 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia that is actively recruiting participants, run by OHSU Knight Cancer Institute. The registered enrollment target is 20 participants, below the 399-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04872790, a Phase 1 study of Mixed Phenotype Acute Leukemia and B Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by OHSU Knight Cancer Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial studies the effects of venetoclax in combination with dasatinib, prednisone, rituximab and blinatumomab in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) that is newly diagnosed or that has come back (relapsed). Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Anti-inflammatory drugs, such as prednisone lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab and blinatumomab are monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving venetoclax in combination with dasatinib, prednisone, and rituximab and blinatumomab may help treat patients with newly diagnosed or relapsed Philadelphia chromosome positive acute lymphoblastic leukemia.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications. In order to be declared a dose-limiting toxicity, an adverse experience must be determined related (definitely, probably, or possibly) to study drug. Point estimates and 95% exact confidence intervals will be reported for all patients in the safety set as well as in subgroups defined by whether or not
Conditions Studied
Interventions
- DRUG Venetoclax
- DRUG Prednisone
- BIOLOGICAL Rituximab
- DRUG Dasatinib
- DRUG Methotrexate
Study Locations (1)
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2026-12-02 |
| Phase | Phase 1 |
What NCT04872790 shows while recruiting
NCT04872790 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 399-participant average among 29 other Mixed Phenotype Acute Leukemia trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Mixed Phenotype Acute Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Venetoclax is the first listed.
NCT04872790 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04872790 about?
NCT04872790 is a clinical study titled "Venetoclax, Dasatinib, Prednisone, Rituximab and Blinatumomab for the Treatment of Newly Diagnosed or Relapsed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia or Mixed Phenotype Acute Leukemia". This phase Ib trial studies the effects of venetoclax in combination with dasatinib, prednisone, rituximab and blinatumomab in treating patients with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) that is newly diagnosed or that has come back (relapsed). Venetoclax may stop the ...
What is the current status of trial NCT04872790?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2022-09-02. Estimated completion is 2026-12-02.
What conditions does trial NCT04872790 study?
This clinical trial studies the following conditions: Mixed Phenotype Acute Leukemia, B Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia, B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1, Recurrent Mixed Phenotype Acute Leukemia.
What interventions are being tested in trial NCT04872790?
The interventions under investigation include: Venetoclax (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL), Dasatinib (DRUG), Methotrexate (DRUG).
Who is sponsoring clinical trial NCT04872790?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04872790 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04872790's enrollment target sits among peer trials
20 28th of 29 higher than 2 of 29 other Mixed Phenotype Acute Leukemia trials
participants (enrollment target), bucketed by value
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