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

Information source: Cooperative Study Group A for Hematology
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bone Marrow Failure Syndromes

Intervention: Cyclophosphamide-fludarabine-anti thymocyte globulin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Cooperative Study Group A for Hematology

Official(s) and/or principal investigator(s):
Kyoo-Hyung Lee, Doctor, Principal Investigator, Affiliation: Asan Medical Center

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.

Clinical Details

Official title: Randomized Comparison of Cyclophosphamide Versus Cyclophosphamide Plus Fludarabine In Addition To Anti-Thymocyte Globulin for the Conditioning Therapy in Allogeneic Hematopoietic Cell Transplantation for Bone Marrow Failure Syndrome

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Occurrence of regimen related toxicities

Secondary outcome: Secondary end point will be the occurrence of engraftment failure (primary and secondary)

Detailed description: This is a prospective, randomized, non-blind study.

Conditioning therapy will start on day - 5 in patients who are randomized to receive Cy+ATG.

Hydration with 0. 45% NaCl at 6 liters/24 hours will be started on day - 5. Cy 50 mg/kg in D5W

200 ml i. v. over 1-2 hours on days - 5 to -2 by pump through a central venous catheter. Mesna

12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0. 5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL

(less than 2 mg/mL) iv daily at 8 am on days - 4 to -2. Premedication for ATG (ALG) will

include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45. 5 mg iv push. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.

Conditioning therapy will start on day - 6 in patients who are randomized to receive

Cy+fludarabine (Fludara®, Berlex Laboratories, Richmond, CA)+ATG. Fludarabine 30 mg/m2 will

be infused intravenously over 30 minutes in D5W 100 ml for 5 consecutive days (days - 6 to

- 2). Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0. 5 mg/mL) or lymphoglobuline 15

mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days - 4 to -2. Premedication

for ATG (ALG) will include methylprednisolone 2 mg/kg iv infusion, Tylenol 600 mg po, and Avil 45. 5 mg iv push. Hydration with 0. 45% NaCl at 6 liters/24 hours will be started on day

- 3. Cy 50 mg/kg in D5W 200 ml i. v. over 1-2 hours on days -3 to -2 by pump through a central

venous catheter. Mesna 12 mg/kg iv push immediately before Cy and 3, 6, 9, and 12 hours after Cy. The doses of cyclophosphamide and ATG (ALG) will be calculated using actual body weight.

Eligibility

Minimum age: 15 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

Asan Medical Center, Seoul 138-736, Korea, Republic of
Additional Information

Cy-ATG vs Cy-Flu-ATG

Starting date: March 2003
Last updated: February 16, 2011

Page last updated: August 20, 2015

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