Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT (CyFluCyATG)
Primary Purpose
Bone Marrow Failure Syndromes
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyclophosphamide-fludarabine-anti thymocyte globulin
Sponsored by
About this trial
This is an interventional treatment trial for Bone Marrow Failure Syndromes
Eligibility 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
Sites / Locations
- Asan Medical Center
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
ArmI(CyATG)
Arm Description
•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
Outcomes
Primary Outcome Measures
Occurrence of regimen related toxicities
1.1 Compare the regimen related toxicities of two different conditioning regimens, cyclophosphamide (Cy)+anti-thymocyte globulin (ATG) (Cy-ATG) vs. reduced dose of Cy+fludarabine (Flu)+ATG (Cy-Flu-ATG) after allogeneic hematopoietic cell transplantation (allo-HCT).
Secondary Outcome Measures
Secondary end point will be the occurrence of engraftment failure (primary and secondary)
Full Information
NCT ID
NCT00774527
First Posted
October 12, 2008
Last Updated
February 16, 2011
Sponsor
Cooperative Study Group A for Hematology
1. Study Identification
Unique Protocol Identification Number
NCT00774527
Brief Title
Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT
Acronym
CyFluCyATG
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cooperative Study Group A for Hematology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Marrow Failure Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ArmI(CyATG)
Arm Type
No Intervention
Arm Description
•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
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide-fludarabine-anti thymocyte globulin
Other Intervention Name(s)
CYCLOPHOSPHAMIDE,FLUDARA,ANTI-THYMOCYTE GLOBULINE
Intervention Description
Cyclophosphamide 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.
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.
Primary Outcome Measure Information:
Title
Occurrence of regimen related toxicities
Description
1.1 Compare the regimen related toxicities of two different conditioning regimens, cyclophosphamide (Cy)+anti-thymocyte globulin (ATG) (Cy-ATG) vs. reduced dose of Cy+fludarabine (Flu)+ATG (Cy-Flu-ATG) after allogeneic hematopoietic cell transplantation (allo-HCT).
Time Frame
7 years
Secondary Outcome Measure Information:
Title
Secondary end point will be the occurrence of engraftment failure (primary and secondary)
Time Frame
7years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyoo-Hyung Lee, Doctor
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
12. IPD Sharing Statement
Links:
URL
http://www.google.co.kr
Description
Cy-ATG vs Cy-Flu-ATG
Learn more about this trial
Comparison of Cy-Atg Vs Cy-Flu-Atg for the Conditioning Therapy in Allo-HCT
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