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Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation (RICandDLI)

This study is currently recruiting participants.
Verified November 2010 by Cooperative Study Group A for Hematology
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01252784
First received: December 1, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Phase
Myelodysplastic Syndrome
 Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • relapse incidence,duration of remission [ Time Frame: 4years ] [ Designated as safety issue: Yes ]
    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:
  • engraftment, donor chimerism, secondary graft failure,GVHD [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    •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.


Estimated Enrollment: 20
Study Start Date: November 2010
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with higher risk MDS

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252784

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:
Reduced-intensity conditioning allogeneic hematopoietic cell transplantation followed by prophylactic dose-escalating donor lymphocyte infusions in higher risk myelodysplastic syndrome  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01252784     History of Changes
Other Study ID Numbers: Allo-039
Study First Received: December 1, 2010
Last Updated: December 1, 2010
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013