Reduced Toxicity Fludarabine (Flu) + Cyclophosphamide (CPM) + Rabbit Antithymocyte Globulin (rATG) Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia (SAA)
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ClinicalTrials.gov Identifier: NCT00882323 |
Recruitment Status : Unknown
Verified March 2012 by The Korean Society of Pediatric Hematology Oncology.
Recruitment status was: Recruiting
First Posted : April 16, 2009
Last Update Posted : March 26, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Aplastic Anemia | Drug: Cyclophosphamide, Fludarabine, Thymoglobulin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 33 participants |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Reduced Toxicity Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Donor Transplantation in Severe Aplastic Anemia |
Study Start Date : | November 2008 |
Estimated Primary Completion Date : | October 2012 |
Estimated Study Completion Date : | October 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Fludarabine |
Drug: Cyclophosphamide, Fludarabine, Thymoglobulin
cyclophosphamide (60 mg/kg once daily i.v. on days -8, -7) fludarabine (40 mg/m2 once daily i.v. on days -6, -5, -4, -3, -2) thymoglobulin (2.5 mg/kg once daily i.v. on days -4, -3, -2) |
- To evaluate engraftment potential of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for unrelated bone marrow transplantation in severe aplastic anemia. [ Time Frame: From Nov. 2008 to Oct. 2012 ]
- To evaluate toxicities of reduced toxicity fludarabine, cyclophosphamide plus thymoglobulin conditioning regimen for UBMT/PBSCT in SAA. [ Time Frame: From Nov. 2008 to Oct. 2012 ]
- To evaluate overall and EFS rate after UBMT/PBSCT. [ Time Frame: From Nov. 2008 to Oct. 2012 ]
- To evaluate GVHD and immunologic recovery after UBMT/PBSCT. [ Time Frame: From Nov. 2008 to Oct. 2012 ]

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Ages Eligible for Study: | 1 Year to 21 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Diagnosis of severe aplastic anemia defined by any two or three peripheral blood criteria and either marrow criterion.
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Peripheral blood
- Neutrophils < 0.5 x 109/l
- Platelets < 20 x 109/l
- Corrected reticulocytes < 1%
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Bone marrow
- Severe hypocellularity (< 25%)
- Moderate hypocellularity (25-30%) with hematopoietic cells representing < 30% of residual cells
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- No prior hematopoietic stem cell transplantation.
- Age: no limits.
- Performance status: ECOG 0-2.
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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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882323
Contact: Hyoung Jin Kang, M.D, Ph.D | 82 2 2072 3304 | kanghj@snu.ac.kr | |
Contact: Ji Won Lee, M.D | 82 2 2072 0177 | agnesjw@hanmil.net |
Korea, Republic of | |
Seoul National University Hospital | Recruiting |
Seoul, Korea, Republic of, 110-744 | |
Contact: Hyo Seop Ahn, M.D, Ph.D 82 2 2072 3625 hsahn@snu.ac.kr |
Principal Investigator: | Hyo seop Ahn, M.D, Ph. D | The Korean Society of Pediatric Hematology Oncology |
Responsible Party: | The Korean Society of Hematology, The Korean Society of Pediatric of Hematology Oncology |
ClinicalTrials.gov Identifier: | NCT00882323 |
Other Study ID Numbers: |
KSPHO-SCT 0802 |
First Posted: | April 16, 2009 Key Record Dates |
Last Update Posted: | March 26, 2012 |
Last Verified: | March 2012 |
Anemia Anemia, Aplastic Hematologic Diseases Bone Marrow Failure Disorders Bone Marrow Diseases Cyclophosphamide Fludarabine Thymoglobulin Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |