Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation (RICandDLI)

Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation Followed by Prophylactic Dose-escalating Donor Lymphocyte Infusions in Higher Risk Myelodysplastic Syndrome

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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Korea, Republic of
  • Asanbyeongwon-gil, songpa-gu
    • Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
      • Recruiting
      • Asan Medical Center
      • Contact: Yae-Eun Jang, nurse; Phone Number: 82-2-3010-6378; Email: redpin75@paran.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with higher risk MDS

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
relapse incidence,duration of remission	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.	4years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
engraftment, donor chimerism, secondary graft failure,GVHD	•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.	4 years

Collaborators and Investigators

• Sponsor: Cooperative Study Group A for Hematology
• Investigators: Principal Investigator: Je-Hwan Lee, Doctor, Asan Medical Center

Publications and helpful links

Helpful Links

• Reduced-intensity conditioning allogeneic hematopoietic cell transplantation followed by prophylactic dose-escalating donor lymphocyte infusions in higher risk myelodysplastic syndrome

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): October 1, 2014

Study Registration Dates

• First Submitted: December 1, 2010
• First Submitted That Met QC Criteria: December 1, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Estimate): December 3, 2010
• Last Update Submitted That Met QC Criteria: December 1, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: higher risk MDS
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia
• Other Study ID Numbers: Allo-039