Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Phase 1

Completed

• Conditions: Leukemia; Myelodysplastic Syndromes

• Registration Number: NCT00112567
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets.

PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-positive-selected haploidentical allogeneic peripheral blood stem cell transplantation in young patients with life-threatening hematologic malignancies.

Secondary

* Determine the risk for severe graft-vs-host disease in patients treated with this regimen.

* Determine the kinetics of immune reconstitution in patients treated with this regimen.

* Determine the risk for life-threatening infections in patients treated with this regimen.

OUTLINE:

* Conditioning regimen: Patients 7 years of age and under undergo total body irradiation twice daily on days -9 to -7. Patients over 7 years of age undergo total body irradiation once on day -7. All patients receive fludarabine IV once daily on days -6 to -2 and thiotepa IV over 2 hours twice on day -5.

* CD34-positive (CD34+)-selected haploidentical allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and 2.

Patients with acute lymphoblastic leukemia or CNS disease also receive methotrexate intrathecally twice before transplantation and 4 times after day 35 post-transplantation. Male patients with lymphoid malignancies undergo additional radiotherapy to the testes.

After completion of study treatment, patients are followed for at least 100 days, at 1 year, and then periodically thereafter.

PROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients \> 7 years of age) will be accrued for this study within 3 years.

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2005-06-02
• Study First Submitted QC: 2005-06-02
• Study First Posted: 2005-06-03
• Study Completion: 2007-07
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-17
• Last Update Posted: 2010-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety

Secondary Outcome Measures

Name	Time	Method
Risk of severe graft-versus-host disease
Kinetics of immune reconstitution
Risk of life-threatening infections

Trial Locations

Locations (2)

Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States