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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 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. The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2021-05-05
Est. Completion 2028-07-01
Phase Phase 2

Sponsor

Fred Hutchinson Cancer Center

483 total trials

What the Registry Record Tells You About NCT03980769

The ClinicalTrials.gov registry entry for NCT03980769 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 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 483 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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