Reduced Intensity Fludarabine and TBI Prior to Haplo-Identical Transplantation

Study Overview
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Brief Summary
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This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.

Official Title
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A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies

Conditions
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Hematologic Malignancy

Intervention / Treatment
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* Other: Fludarabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells KPS >/= 70% Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning. Exclusion Criteria: Poor cardiac function (LVEF <45%) Poor pulmonary function (FEV, FVC, DLCO <60%) Poor liver function (bilirubin >/= 2.5mg/dL; AST or ALT >3xULN) Poor renal function (creatinine clearance <40mL/min) HIV-positive; active HepB or HepC Uncontrolled infection Pregnant female or not able to practice adequate contraception Debilitating medical or psychiatric illness which would preclude their giving informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Fludarabine|Reduced-intensity fludarabine with intermediate-dose TBI|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection |  | 30 days after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who are still alive as assessed by survival status at certain timepoints after transplant |  | 36 months after transplant | 
| Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant |  | 36 months after transplant | 
| Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant |  | 36 months after transplant | 
| Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant |  | 1 year after transplant | 
| Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant |  | 36 months after transplant | 
| Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0 |  | 90 days after transplant |