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Trial record 3 of 52 for:    "Acute Leukemia" | "Anti-Bacterial Agents"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Ho Joon Im, Asan Medical Center

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

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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

Resource links provided by the National Library of Medicine

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

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 ]

Information from the National Library of Medicine

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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

  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

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 identifier (NCT number): NCT01509300

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Contact: Ho Joon Im, MD & PhD 82-2-3010-3371

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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Ho Joon Im, MD & PhD    82-2-3010-3371   
Principal Investigator: Ho Joon Im, MD & PhD         
Sponsors and Collaborators
Asan Medical Center
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Principal Investigator: Ho Joon Im, MD & PhD Asan Medical Center

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ho Joon Im, Principal investigator, Asan Medical Center 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:
CD3 depletion
Children and adolescents
Haploidentical hematopoietic stem cell transplantation
Additional relevant MeSH terms:
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Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Anti-Bacterial Agents
Myelodysplastic Syndromes
Acute Disease
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes
Mycophenolic Acid
Fludarabine phosphate
Antilymphocyte Serum
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action