Cyclophosphamide, Fludarabine and Antithymocyte Globulin Conditioning in Myelodysplastic Syndrome (MDS) (CyFluATG)

This study is currently recruiting participants.
Verified December 2010 by Cooperative Study Group A for Hematology
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01255319
First received: November 30, 2010
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS).


Condition
Myelodysplastic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Conditioning With Cyclophosphamide, Fludarabine and Antithymocyte Globulin for Allogeneic Hematopoietic Cell Transplantation in Lower Risk Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • feasibility and efficacy [ Time Frame: 4years ] [ Designated as safety issue: Yes ]
    To evaluate the feasibility and efficacy of the conditioning regimen with cyclophosphamide, fludarabine and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (the primary endpoints)


Secondary Outcome Measures:
  • progression-free survival, and overall survival [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    This study will also evaluate donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, progression-free survival, and overall survival.


Estimated Enrollment: 15
Study Start Date: November 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Detailed Description:

Conditioning therapy

  • Cytoxan 50 mg/kg/d on d-3 to -2
  • Fludarabine 30 mg/m2 on d-6 to -2
  • Antithymocyte globulin (ATG; Thymoglobulin®) 1.5 mg/kg/d (for HLA-matched sibling donor HCT) or 3.0 mg/kg/d (for other alternative donor HCT)
  • Methylpd 2 mg/kg/d on d-4 to -1

Mobilization and harvest

  • G-CSF 10 mcg/kg/d s.c. on d-3 to 0
  • Harvest of PBMCs on d 0 to +1

Donor G PBMC infusion

  • Infuse G-PBMCs on d 0 to d+1.

GVHD prophylaxis

  • Cyclosporine 1.5 mg/kg i.v. q 12 hrs beginning on d-1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible. Tapered beginning between d+30 and d+60.
  • Methotrexate 15 mg/m2 i.v. on d+2, and 10 mg/m2 i.v. on d+4 and d+7

Preemptive dose-escalating DLIs

  • Begin at d+120 or at least 2 wks after IST discontinuation.
  • Failure to achieve full donor chimerism No evidence of GVHD
  • CD3+ cell dose increment q 4 wks -+ cell dose: HLA-matched donor HCT (1 x 107/kg, 5 x 107/kg, 1 x 108/kg), HLA-matched unrelated donor HCT (1 x 106/kg, 5 x 106/kg, 1 x 107/kg), HLA-matched familial donor HCT (1 x 105/kg, 5 x 105/kg, 1 x 106/kg)
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with lower risk MDS

Criteria

Inclusion Criteria:

  • Patients with lower risk MDS (bone marrow blast percentage < 5%)
  • Patients with appropriate hematopoietic cell donor
  • Adequate performance status (Karnofsky score of 70 or more; see Appendix II)
  • Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
  • Adequate cardiac function (left ventricular ejection fraction of 40% or more on heart scan or echocardiogram)
  • Signed and dated informed consent must be obtained from both recipient and donor.

Exclusion Criteria:

  • Presence of significant active infection
  • Presence of uncontrolled bleeding
  • Any coexisting major illness or organ failure
  • Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
  • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
  • Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01255319

Contacts
Contact: Je-Hwan Lee, Doctor 82-2-3010-3218 jhlee3@amc.seoul.kr
Contact: Ya-Eun Jang, Nurse 82-2-3010-6378 redpin75@paran.com

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
Contact: Yae-Eun Jang, nurse    82-2-3010-6378    redpin75@paran.com   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Je-Hwan Lee, Doctor Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01255319     History of Changes
Other Study ID Numbers: Allo-038
Study First Received: November 30, 2010
Last Updated: December 6, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:
MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Antilymphocyte Serum
Cyclophosphamide
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on April 17, 2014