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NCT04195633 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
A Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04195633: Recruiting Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, sponsored by Fred Hutchinson Cancer Center.
NCT04195633 is a Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 60 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04195633, a Phase 2 study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.
Primary Outcome
The analysis for graft failure will be conducted among all patients as well as separately among patients by Arm A versus Arm B.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL Filgrastim
- DRUG Cyclosporine
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2021-01-25 |
| Est. Completion | 2029-03-12 |
| Phase | Phase 2 |
What NCT04195633 shows while recruiting
NCT04195633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (48% lower).
The record links to 10 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04195633 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT04195633 about?
NCT04195633 is a clinical study titled "Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies". This phase II trial studies how well a donor stem cell transplant, treosulfan, fludarabine, and total-body irradiation work in treating patients with blood cancers (hematological malignancies). Giving chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth o...
What is the current status of trial NCT04195633?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2021-01-25. Estimated completion is 2029-03-12.
What conditions does trial NCT04195633 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myelomonocytic Leukemia, Hodgkin Lymphoma, Acute Leukemia.
What interventions are being tested in trial NCT04195633?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Filgrastim (BIOLOGICAL), Cyclosporine (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE).
Who is sponsoring clinical trial NCT04195633?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195633 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04195633's enrollment target sits among peer trials
60 120th of 306 higher than 180 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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