Human Leukocyte Antigen (HLA)-Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Aplastic Anemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-07-31

Brief Summary

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Rationale: Chemotherapy with 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, depletion CD3±CD19 cells 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 fludarabine, cyclophosphamide and antithymocyte globulin with CD3±CD19 depleted graft from haploidentical donors in treating patients with aplastic anemia.

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Detailed Description

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Conditions

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Aplastic Anemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HAPLO

Group Type EXPERIMENTAL

anti-thymocyte globulin

Intervention Type BIOLOGICAL

On days -3 to -1

filgrastim

Intervention Type BIOLOGICAL

Beginning on day 4 and continuing until blood counts recover

Fludarabine

Intervention Type DRUG

30mg/M2 once daily IV on days -6 to -2

Cyclophosphamide

Intervention Type DRUG

60 mg/kg IV on day-3 and -2

CD3±CD19 depleted hematopoietic stem cell transplantation

Intervention Type PROCEDURE

Immunogenetic depletion on CliniMACS

Interventions

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anti-thymocyte globulin

On days -3 to -1

Intervention Type BIOLOGICAL

filgrastim

Beginning on day 4 and continuing until blood counts recover

Intervention Type BIOLOGICAL

Fludarabine

30mg/M2 once daily IV on days -6 to -2

Intervention Type DRUG

Cyclophosphamide

60 mg/kg IV on day-3 and -2

Intervention Type DRUG

CD3±CD19 depleted hematopoietic stem cell transplantation

Immunogenetic depletion on CliniMACS

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant etiology meeting 2 of the following criteria:

* Granulocyte count \< 500/mm3,
* Corrected reticulocyte count \< 1%,
* Platelet count \< 20,000/mm3
* No HLA-identical family member or closely matched (8 of 8 HLA-locus match) unrelated marrow donor available
* HLA-haploidentical related donor available

Exclusion Criteria

* Paroxysmal nocturnal hemoglobinuria or Fanconi anemia
* Clonal cytogenetic abnormalities or myelodysplastic syndromes
* Active fungal infections
* HIV positive
* Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure
* Pregnant or nursing

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No