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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
Sponsor:
Information provided by (Responsible Party):
Ho Joon Im, Asan Medical Center

Study Description
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Brief 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.


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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Engraftment and graft failure rates [ Time Frame: 28 days engraftment and graft failure ]
    Number of patients who failed to stable engraftment by 28 days

  2. Incidence of acute GVHD [ Time Frame: 100 days post-transplant ]
    Number of patients with acute GVHD.

  3. Treatment related mortality [ Time Frame: 100 days post-transplant ]
    Number of death after transplantation

  4. Relapse rate and overall survival [ Time Frame: 2 year after transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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