A Study of Bone Marrow Transplantation Using Fully-Matched Relatives as Donors for Patients With Hematological Malignancies
Condition: Hematological Malignancies; Leukemia; Lymphoma; Multiple Myeloma; Hodgkin's Disease
MeSH terms: Multiple Myeloma; Neoplasms; Hematologic Neoplasms; Hodgkin Disease
Intervention: Matched Sibling Allogeneic Transplantation
Intervention description: Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myeloablative Hematopoietic Stem Cell Transplant; Cyclophosphamide tolerization; 2 Step Approach; Hematological malignancies; leukemia; lymphoma; multiple myeloma; Hodgkin's Disease

Summary:

      This research study uses a drug called cyclophosphamide to decrease the incidence of GVHD in
      matched sibling hematopoietic stem cell transplant. In doing so, the goal of the study is to
      increase overall survival.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is
             thought to be beneficial, and in whom front-line therapy has already been applied.
             Patients will be considered high-risk if they have any of the following:

               1. Age > 50 years

               2. ECOG Performance status of <2

               3. Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st CR;
                  second or greater CR, 1st relapse; any ph+ ALL

               4. CML 2nd chronic phase, accelerated phase, or blastic phase

               5. MDS with IPS of Intermediate 2 or greater

               6. Any myeloproliferative disorder

               7. Hodgkin lymphoma: relapsed, refractory, or primary induction failure

               8. Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not
                  eligible for an autologous HSCT

               9. Other conditions not listed will be assessed as high-risk by the PI

          2. Patients must have a related donor who is either HLA-identical or a one antigen
             mismatch at the HLA- A; B; C; and DR loci.

          3. Patients must adequate organ function:

               1. LVEF of >45%

               2. DLCO (adjusted for hemoglobin) >45% of predicted

               3. Adequate liver function as defined by a serum bilirubin <1.8, AST or ALT < 2.5X
                  upper limit of normal

               4. Creatinine clearance of > 60 ml/min

          4. Patients must be willing to use contraception if they have childbearing potential

          5. Able to give informed consent

        Exclusion Criteria:

          1. ECOG performance status of 3 or 4.

          2. HIV positive

          3. Active involvement of the central nervous system with malignancy

          4. Psychiatric disorder that would preclude patients from signing an informed consent

          5. Pregnancy

          6. Patients with life expectancy of < 6 months for reasons other than their underlying
             hematologic/oncologic disorder.