A Novel TBI Free Conditioning Protocol for Haploidentical Transplant in Acquired Aplastic Anemia: (FluCAB-Prime)
Aplastic Anemia Idiopathic
About this trial
This is an interventional treatment trial for Aplastic Anemia Idiopathic focused on measuring haploidentical, Aplastic anemia, TBI
Eligibility Criteria
Inclusion Criteria:
- Age >2 years and < 60 years
- Karnofsky performance status >= 70%
Aplastic Anemia that meets the following criteria:
i. Peripheral Blood (must fulfill 2 of 3): ii. <500 neutrophils iii. <20,000 platelets iv. absolute reticulocyte count <40,000/microL
- Bone Marrow (must be ): markedly hypocellular (<25% of normal cellularity) with absence of reticulin and abnormal infiltrate
Exclusion Criteria:
- Presence of donor specific antibodies
- Fanconi anemia
- Cytogenetic abnormalities suggestive of myelodysplastic syndrome
- Prior HSCT
- Human immunodeficiency virus infection
- Active Hepatitis B virus infection
- Active /uncontrolled bacterial, viral , fungal infection or Tuberculosis
- Psychiatric illness
- Poor cardiac function (ejection fraction <40%)
- Poor pulmonary function (Forced vital capacity <50% predicted)
- Poor liver function (bilirubin >= 2mg/dL)
- Poor renal function (creatinine >= 2.0mg/dL or creatinine clearance <40)
Sites / Locations
- NIBMTRecruiting
Arms of the Study
Arm 1
Experimental
TBI free Haploidentical HSCT
Recipients will receive a reduced intensity conditioning regimen of ''Fludarabine'' 30 mg/m2 IV daily from day -7 to -3, ''Cyclophosphamide'' 14.5-30 mg/kg IV daily on day -6 and -5 , ''rabbit Antithymocyte globulin'' 5 mg /kg/day from day -6 to day-3; ''Busulphan'' IV 3.2 mg per kg/day in 02 divided doses on day -3 and day-2, ''Granulocyte Colony Stimulating factor primed Bone marrow harvest'' and/OR ''PBSC'' graft on day 0 and day +1 respectively and Graft versus host disease prophylaxis with ''post-transplant cyclophosphamide'' administered at a dose of 50mg/kg/day given daily on days +3 and +5 post-transplant and ''cyclosporine'' from day +5, ''mycophenolate mofetil'' from day+5 to day+35.