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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2012 by Asan Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Ho Joon Im, Asan Medical Center

ClinicalTrials.gov Identifier:

NCT01509300

First received: January 5, 2012

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Acute Leukemia Myelodysplastic Syndrome Solid Tumors	Biological: anti-thymocyte globulin Biological: filgrastim Radiation: Total body irradiation Drug: Fludarabine Drug: cyclophosphamide Drug: Tacrolimus Drug: Mycophenolate mofetil Drug: Rituximab	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Leukemia Myelodysplastic Syndromes

Drug Information available for: Cyclophosphamide Fludarabine Fludarabine phosphate Tacrolimus Mycophenolate mofetil Rituximab Antilymphocyte Serum

Genetic and Rare Diseases Information Center resources: Myelodysplastic Syndromes

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:

Transplantation-related mortality and overall survival of TBI, Fludarabine, Cyclophosphamide and anti-thymocyte globulin for engraftment of CD3 depleted haploidentical peripheral blood stem cells. [ Time Frame: 2 years post-transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Engraftment and graft failure rates [ Time Frame: 28 days engraftment and graft failure ] [ Designated as safety issue: Yes ]
Number of patients who failed to stable engraftment by 28 days
Incidence of acute GVHD [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: Yes ]
Number of patients with acute GVHD.
Treatment related mortality [ Time Frame: 100 days post-transplant ] [ Designated as safety issue: Yes ]
Number of death after transplantation
Relapse rate and overall survival [ Time Frame: 2 year after transplantation ] [ Designated as safety issue: No ]


Estimated Enrollment:	10
Study Start Date:	January 2012
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: HAPLO	Biological: anti-thymocyte globulin On days -10 to -9 Biological: filgrastim Beginning on day 4 and continuing until blood counts recover Radiation: Total body irradiation 2Gy D-6 to D-4 Drug: Fludarabine 30mg/M2 once daily IV on days -8 to -4 Drug: cyclophosphamide 60 mg/kg IV on day-3 and -2 Drug: Tacrolimus begin on 0 Drug: Mycophenolate mofetil begin on 0 Drug: Rituximab 375mg/m2 on day +21

Eligibility


Ages Eligible for Study:	up to 21 Years (Child, Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

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)
No HLA-identical family member or closely matched (8 or 7 of 8 HLA-locus match) unrelated marrow donor available
HLA-haploidentical related donor available

Exclusion criteria

Active fungal infections
HIV positive
Pregnant or nursing

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01509300

Contacts


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

Locations


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

Sponsors and Collaborators

Asan Medical Center

Investigators


Principal Investigator:	Ho Joon Im, MD & PhD	Asan Medical Center

More Information

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Im HJ, Koh KN, Suh JK, Lee SW, Choi ES, Jang S, Kwon SW, Park CJ, Seo JJ. Refinement of treatment strategies in ex vivo T-cell-depleted haploidentical SCT for pediatric patients. Bone Marrow Transplant. 2015 Feb;50(2):225-31. doi: 10.1038/bmt.2014.232. Epub 2014 Oct 13.


Responsible Party:	Ho Joon Im, Principal investigator, Asan Medical Center
ClinicalTrials.gov Identifier:	NCT01509300 History of Changes
Other Study ID Numbers:	AMCPHO-SCT0902
Study First Received:	January 5, 2012
Last Updated:	January 12, 2012
Health Authority:	Korea: Institutional Review Board

Keywords provided by Asan Medical Center:


TBI Fludarabine CD3 depletion Children and adolescents Haploidentical hematopoietic stem cell transplantation

Additional relevant MeSH terms:


Leukemia Syndrome Myelodysplastic Syndromes Preleukemia Acute Disease Neoplasms by Histologic Type Neoplasms Disease Pathologic Processes Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Disease Attributes Cyclophosphamide Fludarabine phosphate	Mycophenolate mofetil Tacrolimus Antilymphocyte Serum Rituximab Fludarabine Mycophenolic Acid Vidarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents

ClinicalTrials.gov processed this record on September 26, 2016

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