Reduced-intensity Conditioning Allogeneic Hematopoietic Cell Transplantation

NCT01252784 | Unknown

• 1 other identifier: Allo-039
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelodysplastic Syndrome

Keywords

higher risk MDS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• engraftment, donor chimerism, secondary graft failure,GVHD

  4 years

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with higher risk MDS

You may qualify if:

• Patients with higher risk MDS including chronic myelomonocytic leukemia
• RAEB-1 or RAEB-2
• IPSS Intermediate-2 or High risk category
• Chronic myelomonocytic leukemia
• Patients with appropriate hematopoietic cell donor
• HLA-matched sibling
• HLA-matched unrelated donor
• HLA-mismatched familial donor 3.16 years old or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

RECRUITING

Related Links

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

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.

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Je-Hwan Lee, Doctor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Je-Hwan Lee, Doctor

CONTACT

82-2-3010-3218; jhlee3@amc.seoul.kr

Ya-Eun Jang, Nurse

CONTACT

82-2-3010-6378; redpin75@paran.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: December 1, 2010
• First Posted: December 3, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2014
• Last Updated: December 3, 2010

Record last verified: 2010-11

Locations

KR (1)