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NCT03980769 · ClinicalTrials.gov registry record · Phase 2
Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders
A Phase 2 study of Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03980769: Recruiting Phase 2 study of Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder, sponsored by Fred Hutchinson Cancer Center.
NCT03980769 is a Phase 2 study of Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03980769, a Phase 2 study of Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II clinical trial studies how well treosulfan, thiotepa, fludarabine, and rabbit anti-thymocyte globulin (rATG) before donor stem cell transplantation works in treating patients with nonmalignant (non-cancerous) diseases. Hematopoietic cell transplantation has been shown to be curative for many patients with nonmalignant (non-cancerous) diseases such as primary immunodeficiency disorders, immune dysregulatory disorders, hemophagocytic lymphohistiocytosis, bone marrow failure syndromes, and hemoglobinopathies. Powerful chemotherapy drugs are often used to condition the patient before infusion of the new healthy donor cells. The purpose of the conditioning therapy is to destroy the patient's abnormal bone marrow which doesn't work properly in order to make way for the new healthy donor cells which functions normally. Although effective in curing the patient's disease, many hematopoietic cell transplantation regimens use intensive chemotherapy which can be quite toxic, have significant side effects, and can potentially be life-threatening. Investigators are investigating whether a new conditioning regimen that uses less intensive drugs (treosulfan, thiotepa, and fludarabine phosphate) results in new blood-forming cells (engraftment) of the new donor cells without increased toxicities in patients with nonmalignant (non-cancerous) diseases.
Primary Outcome
Will be defined as donor CD3 chimerism \< 5% at 1 year after transplant.
Conditions Studied
Interventions
- DRUG Thiotepa
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- DRUG Treosulfan
- BIOLOGICAL Rabbit Anti-Thymocyte Globulin
Study Locations (1)
Washington
- Fred Hutch/University of Washington Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2028-07-01 |
| Phase | Phase 2 |
What NCT03980769 shows while recruiting
NCT03980769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder appearing as the primary indexed condition, and to 5 interventions - of which Thiotepa is the first listed.
NCT03980769 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT03980769 about?
NCT03980769 is a clinical study titled "Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Thiotepa in Treating Patients With Non-malignant Disorders". This phase II clinical trial studies how well treosulfan, thiotepa, fludarabine, and rabbit anti-thymocyte globulin (rATG) before donor stem cell transplantation works in treating patients with nonmalignant (non-cancerous) diseases. Hematopoietic cell transplantation has been shown to be curative fo...
What is the current status of trial NCT03980769?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2021-05-05. Estimated completion is 2028-07-01.
What conditions does trial NCT03980769 study?
This clinical trial studies the following conditions: Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder.
What interventions are being tested in trial NCT03980769?
The interventions under investigation include: Thiotepa (DRUG), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Treosulfan (DRUG), Rabbit Anti-Thymocyte Globulin (BIOLOGICAL).
Who is sponsoring clinical trial NCT03980769?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03980769 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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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03980769's enrollment target sits among peer trials
40 1362nd of 2000 higher than 543 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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