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

This study is currently recruiting participants.

Verified January 2012 by Asan Medical Center

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

Tracking Information

First Received Date ^ICMJE

January 5, 2012

Last Updated Date

January 12, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01509300 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Leukemia
Myelodysplastic Syndrome
Solid Tumors

Intervention ^ICMJE

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

Study Arm (s)

Experimental: HAPLO

Interventions:

Biological: anti-thymocyte globulin
Biological: filgrastim
Radiation: Total body irradiation
Drug: Fludarabine
Drug: cyclophosphamide
Drug: Tacrolimus
Drug: Mycophenolate mofetil
Drug: Rituximab

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2014

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ho Joon Im, MD & PhD

82-2-3010-3371

hojim@amc.seoul.kr

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT01509300

Other Study ID Numbers ^ICMJE

AMCPHO-SCT0902

Has Data Monitoring Committee

Not Provided

Responsible Party

Ho Joon Im, Asan Medical Center

Study Sponsor ^ICMJE

Asan Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ho Joon Im, MD & PhD

Asan Medical Center

Information Provided By

Asan Medical Center

Verification Date

January 2012

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

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