Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation (RICandDLI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01252784
Recruitment Status : Unknown
Verified November 2010 by Cooperative Study Group A for Hematology.
Recruitment status was:  Recruiting
First Posted : December 3, 2010
Last Update Posted : December 3, 2010
Information provided by:
Cooperative Study Group A for Hematology

Brief Summary:
The purpose of this study is to evaluate the feasibility and efficacy of reduced-intensity conditioning allogeneic HCT followed by prophylactic dose-escalating DLIs in patients with higher risk MDS.

Condition or disease
Myelodysplastic Syndrome

Detailed Description:

Conditioning therapy

  • Busulfan 3.2 mg/kg/d on d-7 to -6
  • Fludarabine 30 mg/m2 on d-7 to -2
  • ATG 1.5-3.0 mg/kg/d on d-3 to -1
  • Methylpred 2 mg/kg/d on d-4 to -1

Mobilization and harvest

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

Infuse G-PBMCs on d 0 to d+1.

  • Donor G-PBMC infusion

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

Prophylactic dose-escalating DLIs

  • Begin at d+120 or at least 2 wks after IST discontinuation.
  • No evidence of recurrence or GVHD CD3+ cell dose increment q 4 wks 4Three dose levels

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome
Study Start Date : November 2010
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. relapse incidence,duration of remission [ Time Frame: 4years ]
    The efficacy of the treatment will be measured in terms of relapse incidence and duration of remission (the primary endpoints). The hematopoietic cell donors in the study will include HLA-matched sibling, HLA-matched unrelated donors, and HLA-mismatched familial donors.

Secondary Outcome Measures :
  1. engraftment, donor chimerism, secondary graft failure,GVHD [ Time Frame: 4 years ]
    •This study will evaluate engraftment, donor chimerism, secondary graft failure, acute and chronic graft-versus-host disease (GVHD), immune recovery, infections, non-relapse mortality, progression-free survival (PFS), and OS.

Biospecimen Retention:   None Retained
This clinical trial will use busulfan, fludarabine, thymoglobulin and methylprednisolone for conditioning therapy, and cyclosporine and methotrexate for prevention of GVHD. All drugs had been previously accepted for administration to human in respective indication and there is no need to further evaluate the efficacy and the safety of each drug separately. Dose-escalating DLI is also widely accepted procedure after allogeneic HCT.

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with higher risk MDS

Inclusion Criteria:

  1. Patients with higher risk MDS including chronic myelomonocytic leukemia

    • RAEB-1 or RAEB-2
    • IPSS Intermediate-2 or High risk category
    • Chronic myelomonocytic leukemia
  2. Patients with appropriate hematopoietic cell donor

    • HLA-matched sibling
    • HLA-matched unrelated donor
    • HLA-mismatched familial donor 3.16 years old or older

Exclusion Criteria:

  • • Presence of significant active infection

    • Presence of uncontrolled bleeding
    • Any coexisting major illness or organ failure
    • Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01252784

Contact: Je-Hwan Lee, Doctor 82-2-3010-3218
Contact: Ya-Eun Jang, Nurse 82-2-3010-6378

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   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Principal Investigator: Je-Hwan Lee, Doctor Asan Medical Center

Additional Information:
Responsible Party: COSAH, Cooperative Study Group A for Hematology Identifier: NCT01252784     History of Changes
Other Study ID Numbers: Allo-039
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: November 2010

Keywords provided by Cooperative Study Group A for Hematology:
higher risk MDS

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions