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HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Leukemia; Myelodysplastic Syndrome; Solid Tumors

Intervention: anti-thymocyte globulin (Biological); filgrastim (Biological); Total body irradiation (Radiation); Fludarabine (Drug); cyclophosphamide (Drug); Tacrolimus (Drug); Mycophenolate mofetil (Drug); Rituximab (Drug)

Phase: Phase 1/Phase 2

Status: Recruiting

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Ho Joon Im, MD & PhD, Principal Investigator, Affiliation: Asan Medical Center

Overall contact:
Ho Joon Im, MD & PhD, Phone: 82-2-3010-3371, Email: hojim@amc.seoul.kr

Summary

RATIONALE: Conditioning with total body irradiation (TBI) and fludarabine, cyclophosphamide and anti-thymocyte globulin may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, T-cell depletion may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation. PURPOSE: This phase I/II trial is to evaluate the safety and efficacy of TBI, fludarabine, cyclophosphamide and antithymocyte globulin with T-cell depleted graft from haploidentical donors in treating patients with acute leukemia and myelodysplastic syndrome.

Clinical Details

Official title: HLA-haploidentical Allogeneic Hematopoietic Cell Transplantation Using CD3 Depletion for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors After Conditioning of TBI, Fludarabine, Cyclophosphamide and Antithymocyte Globulin

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells.

Secondary outcome:

Engraftment and graft failure rates

Incidence of acute GVHD

Treatment related mortality

Relapse rate and overall survival

Eligibility

Minimum age: N/A. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria 1. Disease characteristics

- Acute lymphoblastic leukemia (first remission, high risk; beyond first

remission; refractory)

- Acute myeloblastic leukemia (first remission, high risk; beyond first remission;

refractory)

- Myelodysplastic syndrome

- Solid tumors (Refractory/relapse)

2. No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available 3. HLA-haploidentical related donor available Exclusion criteria 1. Active fungal infections 2. HIV positive 3. Pregnant or nursing

Locations and Contacts

Ho Joon Im, MD & PhD, Phone: 82-2-3010-3371, Email: hojim@amc.seoul.kr

Asan Medical Center, Seoul 138-736, Korea, Republic of; Recruiting
Ho Joon Im, MD & PhD, Phone: 82-2-3010-3371, Email: hojim@amc.seoul.kr
Ho Joon Im, MD & PhD, Principal Investigator
Additional Information

Related publications:

Koh KN, Im HJ, Kim BE, Choi ES, Jang S, Kwon SW, Park CJ, Seo JJ. Haploidentical haematopoietic stem cell transplantation using CD3 or CD3/CD19 depletion and conditioning with fludarabine, cyclophosphamide and antithymocyte globulin for acquired severe aplastic anaemia. Br J Haematol. 2012 Apr;157(1):139-42. doi: 10.1111/j.1365-2141.2011.08924.x. Epub 2011 Nov 5.

Lang P, Handgretinger R. Haploidentical SCT in children: an update and future perspectives. Bone Marrow Transplant. 2008 Oct;42 Suppl 2:S54-9. doi: 10.1038/bmt.2008.285. Review.

Starting date: January 2012
Last updated: January 12, 2012

Page last updated: August 20, 2015

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