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

January 5, 2012
January 12, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01509300 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
HLA-haploidentical Hematopoietic Stem Cell Transplantation for Children and Adolescents With Acute Leukemia, Myelodysplastic Syndrome and Solid Tumors
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Leukemia
  • Myelodysplastic Syndrome
  • Solid Tumors
  • 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
Experimental: HAPLO
Interventions:
  • Biological: anti-thymocyte globulin
  • Biological: filgrastim
  • Radiation: Total body irradiation
  • Drug: Fludarabine
  • Drug: cyclophosphamide
  • Drug: Tacrolimus
  • Drug: Mycophenolate mofetil
  • Drug: Rituximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact: Ho Joon Im, MD & PhD 82-2-3010-3371 hojim@amc.seoul.kr
Korea, Republic of
 
NCT01509300
AMCPHO-SCT0902
Not Provided
Ho Joon Im, Asan Medical Center
Asan Medical Center
Not Provided
Principal Investigator: Ho Joon Im, MD & PhD Asan Medical Center
Asan Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP