HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors
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ClinicalTrials.gov Identifier: NCT01509300 |
Recruitment Status
: Unknown
Verified January 2012 by Ho Joon Im, Asan Medical Center.
Recruitment status was: Recruiting
First Posted
: January 13, 2012
Last Update Posted
: January 13, 2012
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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 or disease | Intervention/treatment | 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 (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
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
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- 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 ]
- Engraftment and graft failure rates [ Time Frame: 28 days engraftment and graft failure ]Number of patients who failed to stable engraftment by 28 days
- Incidence of acute GVHD [ Time Frame: 100 days post-transplant ]Number of patients with acute GVHD.
- Treatment related mortality [ Time Frame: 100 days post-transplant ]Number of death after transplantation
- Relapse rate and overall survival [ Time Frame: 2 year after transplantation ]

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Ages Eligible for Study: | up to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01509300
Contact: Ho Joon Im, MD & PhD | 82-2-3010-3371 | hojim@amc.seoul.kr |
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 |
Principal Investigator: | Ho Joon Im, MD & PhD | Asan Medical Center |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Ho Joon Im, Principal investigator, Asan Medical Center |
ClinicalTrials.gov Identifier: | NCT01509300 History of Changes |
Other Study ID Numbers: |
AMCPHO-SCT0902 |
First Posted: | January 13, 2012 Key Record Dates |
Last Update Posted: | January 13, 2012 |
Last Verified: | January 2012 |
Keywords provided by Ho Joon Im, Asan Medical Center:
TBI Fludarabine CD3 depletion Children and adolescents Haploidentical hematopoietic stem cell transplantation |
Additional relevant MeSH terms:
Syndrome Leukemia Myelodysplastic Syndromes Preleukemia Acute Disease Disease Pathologic Processes Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Disease Attributes Cyclophosphamide Tacrolimus |
Fludarabine phosphate 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 Myeloablative Agonists |