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RECRUITING Phase 2

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

NCT04195633 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2021-01-25
Est. Completion 2029-03-12
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

319 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04195633

The ClinicalTrials.gov registry entry for NCT04195633 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04195633 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04195633?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial