NCT00354419

Cyclophosphamide, Antithymocyte Globulin, and Total-Body Irradiation in Treating Patients With Severe Aplastic Anemia Undergoing Umbilical Cord Blood Transplant

A Dose Finding Study of Total Body Irradiation for Conditioning Patients With Severe Aplastic Anemia Transplanted With Umbilical Cord Blood

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of abnormal cells. It also helps 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of total-body irradiation when given together with cyclophosphamide and antithymocyte globulin in treating patients with severe aplastic anemia undergoing umbilical cord blood transplant.

Detailed description

OBJECTIVES: I. The objective of this study is to determine the lowest dose of total body irradiation combined with cyclophosphamide and antithymocyte globulin that will achieve sustained engraftment in patients with severe aplastic anemia transplanted with unrelated umbilical cord blood. OUTLINE: This is a dose-escalation study of total-body irradiation (TBI). MYELOABLATIVE CONDITIONING REGIMEN: Patients receive cyclophosphamide IV on days -7 to -4, -6 to -3, or -5 to -2 and antithymocyte globulin IV on days -6 to -4, -5 to -3, or -4 to -2. TBI: Patients undergo TBI twice daily on days -3, -2, and/or -1. UMBILICAL CORD BLOOD TRANSPLANTATION (UCBT): Patients undergo UCBT on day 0. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 1 and continuing until blood counts recover. GRAFT-VS-HOST DISEASE (GVHD) PROPHYLAXIS: Patients receive cyclosporine IV or orally (twice daily for patients \>= 6 years of age or 3 times daily for patients \< 6 years of age) on days -1 to +180 and mycophenolate mofetil IV or orally (twice daily for patients \>= 50 kg or 3 times daily for patients \< 50 kg) beginning 4 hours after UCBT and continuing until approximately day +0. After completion of study therapy, patients are followed periodically.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
RADIATION	total-body irradiation	Undergo radiotherapy
DRUG	cyclophosphamide	Given IV
BIOLOGICAL	anti-thymocyte globulin	Given IV
DRUG	cyclosporine	Given IV
PROCEDURE	umbilical cord blood transplantation	Undergo transplantation
DRUG	mycophenolate mofetil	Given IV or orally
PROCEDURE	bone marrow aspiration	Correlative study
GENETIC	DNA analysis	Correlative study
BIOLOGICAL	filgrastim	Given IV or SC

Timeline

• Start date: 2006-02-01
• Primary completion: 2010-12-01
• First posted: 2006-07-20
• Last updated: 2011-01-05

Locations

1 site across 1 country: United States