search
Back to results

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
Cooperative Study Group A for Hematology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Marrow Failure Syndromes

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 12, 2008
Last Updated
February 16, 2011
Sponsor
Cooperative Study Group A for Hematology
search

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

We'll reach out to this number within 24 hrs