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Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation 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: Aplastic Anemia

Intervention: Cyclophosphamide, Fludarabine, Thymoglobulin (Drug)

Phase: Phase 2

Status: 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

Overall contact:
Hyoung Jin Kang, M.D, Ph.D, Phone: 82 2 2072 3304, Email: kanghj@snu.ac.kr

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 graft versus host disease (GVHD) and rejection of organ transplants. As the fludarabine based conditioning regimens without total body irradiation have been reported to be promising for transplantation from alternative donors in SAA, thymoglobulin was added to fludarabine and cyclophosphamide conditioning to reduce GVHD and to allow good engraftment in unrelated donor transplantation. Our previous phase II study of fludarabine, cyclophosphamide plus thymoglobulin conditioning resulted in good engraftment (100%) and survival rate (74%). But grade III/IV toxicities occurred in 25% of patients and all events were treatment related mortalities. As cyclophosphamide is more toxic agent than fludarabine, we plan a new phase II study re; 'reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated donor transplantation in severe aplastic anemia' by reducing dosage of cyclophosphamide and increasing dosage of fludarabine.

Clinical Details

Official title: Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate engraftment potential of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated bone marrow transplantation in severe aplastic anemia.

Secondary outcome:

To evaluate toxicities of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for UBMT/PBSCT in SAA.

To evaluate overall and EFS rate after UBMT/PBSCT.

To evaluate GVHD and immunologic recovery after UBMT/PBSCT.

Eligibility

Minimum age: 1 Year. Maximum age: 21 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. 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 2. No prior hematopoietic stem cell transplantation. 3. Age: no limits. 4. Performance status: ECOG 0-2. 5. Patients must be free of significant functional deficits in major organs, but the following eligibility criteria may be modified in individual cases:

- Heart: a shortening fraction > 30% and ejection fraction > 45%.

- Liver: total bilirubin < 2 × upper limit of normal; ALT < 3 × upper

- Kidney: creatinine <2 × normal or a creatinine clearance (GFR) > 60

ml/min/1. 73m2. 6. Patients must lack any active viral infections or active fungal infection. 7. Appropriate donor is available: Matched in 6/6 of A, B, DR loci. 8. Patients (or one of parents if patients age < 19) should sign informed consent. Exclusion Criteria: 1. Pregnant or nursing women. 2. Malignant or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy. 3. Psychiatric disorder that would preclude compliance. 4. Congenital aplastic anemia including Fanconi anemia. 5. Manipulated bone marrow.

Locations and Contacts

Hyoung Jin Kang, M.D, Ph.D, Phone: 82 2 2072 3304, Email: kanghj@snu.ac.kr

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Hyo Seop Ahn, M.D, Ph.D, Phone: 82 2 2072 3625, Email: hsahn@snu.ac.kr
Additional Information

Starting date: November 2008
Last updated: March 23, 2012

Page last updated: August 23, 2015

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