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Flu+CPM+rATG Conditioning Regimes for Unrelated Bone Marrow Transplantation (UBMT)(or Mobilized Peripheral Blood)in Severe Aplastic Anemia (SAA)

Information source: The Korean Society of Pediatric Hematology Oncology
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anemia, Aplastic

Intervention: cyclophosphamide, fludarabine , thymoglobulin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: The Korean Society of Pediatric Hematology Oncology

Official(s) and/or principal investigator(s):
Hyo Seop Ahn, M.D, Ph.D, Principal Investigator, Affiliation: The Korean Society of Pediatric Hematology Oncology

Summary

Anti-thymocyte globulin (ATG) has been used in severe aplastic anemia as a part of the conditioning regimen. Among the many kinds of ATG preparations, thymoglobulin had been found to be more effective in preventing GVHD and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for BMT/PBSCT from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in UBMT/UPBSCT.

Clinical Details

Official title: Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic Anemia

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

To evaluate the engraftment potential, incidence and severity of acute graft versus host disease,toxicity of conditioning regimen for UBMT in SAA.

To evaluate overall and EFS follow-up of 1 year after UBMT/PBSCT.

Secondary outcome: To evaluate chronic GVHD and immunologic recovery after UBMT/PBSCT. and the efficacy of UBMT/PBSCT before immuno-suppressive therapy with anti-thymocyte globulin in severe aplastic anemia and long term toxicity of non-TBI based conditioning

Detailed description: GVHD prophylaxis recommendation tacrolimus (0. 03 mg/kg/day i. v. by continuous infusion from

day - 2 and taper with an oral form until 1 year after BMT/PBSCT) methotrexate (15 mg/m2 i. v.

on days 1 and 10 mg/m2 i. v. on days 3, 6, 11)

Eligibility

Minimum age: N/A. Maximum age: 25 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diagnosis of severe aplastic anemia defined by any two or three peripheral blood

criteria

- and either marrow criterion.

- Peripheral blood

1. Neutrophils < 0. 5 x 109/l 2. Platelets < 20 x 109/l 3. Corrected reticulocytes < 1%

- Bone marrow

1. Severe hypocellularity (< 25%) 2. Moderate hypocellularity (25-30%) with hematopoietic cells representing < 30% of residual cells

- No prior hematopoietic stem cell transplantation.

- Age: no limits.

- Performance status: ECOG 0-2.

- Patients must be free of significant functional deficits in major organs, but the

following eligibility criteria may be modified in individual cases. 1. Heart: a shortening fraction > 30%, ejection fraction > 45%. 2. Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper limit of normal. 3. Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60 ml/min/1. 73m2.

- Patients must lack any active viral infections or active fungal infection.

- Appropriate donor is available: Matched in 6/6 of A, B, DR loci.

- Patients (or one of parents if patients age < 19) should sign informed consent.

Exclusion Criteria:

- Pregnant or nursing women.

- Malignant or nonmalignant illness that is uncontrolled or whose control may be

jeopardized by complications of study therapy.

- Psychiatric disorder that would preclude compliance.

- Congenital aplastic anemia including Fanconi anemia.

- Manipulated bone marrow.

Locations and Contacts

Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: January 2006
Last updated: March 23, 2012

Page last updated: August 23, 2015

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