Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized comparison of cyclophosphamide versus reduced-dose cyclophosphamide plus fludarabine in addition to anti-thymocyte globulin for the conditioning therapy in allogeneic hematopoietic cell transplantation for bone marrow failure syndrome.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cooperative Study Group A for Hematology
• Treatments: Antilymphocyte Serum; Cyclophosphamide; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• Patients with bone marrow failure syndrome.

• Written informed consent must be obtained from the patients and donors.

• Patients should have an HLA-identical or one-locus mismatched sibling, family or unrelated donor who is 60 years or less.

• Patients should be 15 years of age or older, but younger than 60 years.

• The performance status of the patients should be 70 or over by Karnofsky performance scale (see Appendix I).

• Patients should not have major illness or organ failure.

• Patients must have adequate hepatic function (bilirubin less than 2 mg/dl, AST and ALT less than three times the upper normal limit).

• Patients must have adequate renal function (creatinine less than 2.0 mg/dl).

• Patients must have adequate cardiac function (ejection fraction > 45% on MUGA scan).

• Patients must not have a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlikely, and making informed consent impossible.

• Patients must not be in pregnancy.

Exclusion Criteria:

• Patients should have major illness or organ failure