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NCT05453500 · ClinicalTrials.gov registry record · Phase 2
Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia
A Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, sponsored by University of Washington.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05453500 is a Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative that is actively recruiting participants, run by University of Washington. The registered enrollment target is 30 participants, below the 155-participant average among 6 other B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05453500, a Phase 2 study of B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab \[DA-EPOCH+/-R\]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphia chromosome negative (Ph-) B acute lymphoblastic leukemia (B-ALL). Chemotherapy drugs, such as those in EPOCH+/-R, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Tafasitamab is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. Adding tafasitamab to the DA-EPOCH+/-R regimen may work better than DA-EPOCH+/-R alone in treating newly diagnosed Ph- B-ALL.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Etoposide
- DRUG Prednisone
- BIOLOGICAL Rituximab
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-03-27 |
| Est. Completion | 2031-05-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05453500
The ClinicalTrials.gov registry entry for NCT05453500 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 155-participant average among 6 other B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative trials with a reported enrollment target (81% lower). The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05453500 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05453500 about?
NCT05453500 is a clinical study titled "Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia". This phase II clinical trial tests a chemotherapy regimen (dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin with or without rituximab \[DA-EPOCH+/-R\]) with the addition of targeted therapy (tafasitamab) for the treatment of patients with newly diagnosed Philadelphi...
What is the current status of trial NCT05453500?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-03-27. Estimated completion is 2031-05-01.
What conditions does trial NCT05453500 study?
This clinical trial studies the following conditions: B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative.
What interventions are being tested in trial NCT05453500?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Etoposide (DRUG), Prednisone (DRUG), Rituximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT05453500?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05453500 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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