Haploidentical Donor Hematopoietic Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Condition: Malignant Neoplasm
MeSH terms: Neoplasms
Intervention: Total-body irradiation; Donor lymphocytes infusion (DLI); Cyclophosphamide; Allogeneic hematopoietic stem cell transplantation (HSCT); Tacrolimus; Mycophenolate mofetil
Intervention description: Undergo TBI; Undergo DLI; Given IV; Undergo haploidentical allogeneic HSCT; Given IV; Given IV
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well haploidentical donor hematopoietic stem cell transplant
      works in treating patients with hematologic malignancies. Giving chemotherapy and total-body
      irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It may
      also stop the patient's immune system from rejecting the donor's stem cells. Giving an
      infusion of the donor's T cells (donor lymphocyte infusion) may replace the patient's immune
      cells and help destroy any remaining cancer cells. When the stem cells from a related donor,
      that closely matches the patient's blood, are infused into the patient they may help the
      patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with a hematologic or oncologic diagnosis without morphological evidence
             of disease in which allogeneic HSCT is thought to be beneficial.

          2. Patients must have a related donor who is a two or more allele mismatch at the HLA-A;
             B; C; DR loci.

          3. Patients must have adequate organ function:

               1. LVEF (Left ventricular ejection fraction) of >50%

               2. Diffusion Capacity for Carbon Monoxide (DLCO) >50% of predicted corrected for
                  hemoglobin

               3. Adequate liver function as defined by a serum bilirubin <1.8, Aspartate
                  Aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5X upper limit of
                  normal

               4. Creatinine clearance of > 60 ml/min

          4. Performance status > 80% (TJU Karnofsky)

          5. Hematopoietic Comorbidity Index (HCT-CI) Score < 5 Points

          6. Patients must be willing to use contraception if they have childbearing potential

          7. Able to give informed consent, or if decisionally impaired, have a legal next of kin
             or guardian that can give informed consent

        Exclusion Criteria:

          1. Performance status < 80 % (TJU Karnofsky)

          2. HCT-CI Score > 5 Points

          3. Combination of Performance status of < 80% (TJU Karnofsky) and an HCT-CI of 4 points
             or more.

          4. HIV positive

          5. Active involvement of the central nervous system with malignancy

          6. Psychiatric disorder that would preclude patients from signing an informed consent

          7. Pregnancy

          8. Patients with life expectancy of < 6 months for reasons other than their underlying
             hematologic/oncologic disorder

          9. Patients who have received alemtuzumab within 8 weeks of the transplant admission, or
             who have recently received horse or rabbit anti-thymocyte globulin and have an ATG
             level of > 2 ugm/ml

         10. Patients who cannot receive cyclophosphamide

         11. Patients with evidence of another malignancy, exclusive of a skin cancer that requires
             only local treatment, should not be enrolled on this protocol