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

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ClinicalTrials.gov Identifier: NCT00737685
Recruitment Status : Unknown
Verified March 2012 by The Korean Society of Pediatric Hematology Oncology.
Recruitment status was:  Active, not recruiting
First Posted : August 19, 2008
Last Update Posted : March 26, 2012
Sponsor:
Information provided by:
The Korean Society of Pediatric Hematology Oncology

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Anemia, Aplastic Drug: cyclophosphamide, fludarabine , thymoglobulin Phase 2

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)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fludarabine, Cyclophosphamide Plus Thymoglobulin Conditioning Regimen for Unrelated Bone Marrow (or Mobilized Peripheral Blood) Transplantation in Severe Aplastic Anemia
Study Start Date : January 2006
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Fludarabine Drug: cyclophosphamide, fludarabine , thymoglobulin
cyclophosphamide (50 mg/kg once daily i.v. on days -9, -8, -7 & -6) fludarabine (30 mg/m2 once daily i.v. on days -5, -4, -3 & -2) thymoglobulin (2.5 mg/kg once daily i.v. on days -3, -2 & -1)


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the engraftment potential, incidence and severity of acute graft versus host disease,toxicity of conditioning regimen for UBMT in SAA. [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years. ]
  2. To evaluate overall and EFS follow-up of 1 year after UBMT/PBSCT. [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: From Jan. 1. 2006 to Dec. 31. 2008. For 3 years. ]

Eligibility Criteria
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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00737685


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
The Korean Society of Pediatric Hematology Oncology
Investigators
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Principal Investigator: Hyo Seop Ahn, M.D, Ph.D The Korean Society of Pediatric Hematology Oncology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hyo Seop Ahn, Seoul Natioanl University Hospital
ClinicalTrials.gov Identifier: NCT00737685    
Other Study ID Numbers: KSPHO-SCT0401
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: March 26, 2012
Last Verified: March 2012
Keywords provided by The Korean Society of Pediatric Hematology Oncology:
Pediatric
UBMT
Severe
Additional relevant MeSH terms:
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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