Bone Marrow Transplant From Partially Matched Donors and Nonmyeloablative Conditioning for Blood Cancers (BMT CTN 0603)
Condition: Precursor B-Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Burkitt Lymphoma; Lymphoma, B-Cell; Lymphoma, Follicular; Lymphoma, Large B-Cell, Diffuse
MeSH terms: Burkitt Lymphoma; Lymphoma; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia, Myeloid; Lymphoma, B-Cell; Leukemia, Myeloid, Acute; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Follicular; Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Intervention: Haploidentical Bone Marrow Transplantation; GVHD prophylaxis
Intervention description: The transplant preparative regimen is listed below. The - sign is the number of days before the transplant.
Fludarabine: 30 mg/m2 intravenously (IV) on Days -6, -5, -4, -3, and -2
Cyclophosphamide (Cy): 14.5 mg/kg IV on Days -6 and -5
Total body irradiation (TBI): 200 centigray (cGy) on Day -1
Day 0 is the day of the infusion of non-T-cell depleted bone marrow. The bone marrow will be obtained from haploidentical related donor.; The GVHD prophylaxis regimen will consist of the following:
Cy: 50 mg/kg IV on Days 3 and 4
Tacrolimus: (IV or orally) beginning on Day 5 with dose adjusted to maintain a level of 5 to 15 mg/mL
Mycophenolate mofetil (MMF): 15 mg/kg orally three times a day (TID) beginning on Day 5; maximum dose will be 1 g orally TID
Granulocyte-colony stimulating factor (G-CSF) 5 mcg/kg/day beginning on Day 5 until absolute neutrophil count (ANC) is greater than or equal to 1,000/mm^3 for 3 consecutive days
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 1 Year
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Acute Lymphoblastic Leukemia/Lymphoma; Acute Myelogenous Leukemia; Mantel-Cell Lymphoma; Hematopoietic Transplant; Haplo-Identical Transplant; Non-Myeloablative Transplant

Summary:

      Bone marrow transplants are one treatment option for people with leukemia or lymphoma. Family
      members or unrelated donors with a similar type of bone marrow usually donate their bone
      marrow to the transplant patients. This study will evaluate the effectiveness of a new type
      of bone marrow transplant-one that uses lower doses of chemotherapy and bone marrow donated
      from family members with only partially matched bone marrow-in people with leukemia or
      lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must be 21 to 70 years old; participants 1 to 21 years old are also
             eligible if they are ineligible for BMT CTN #0501 (NCT00412360)

          -  Donor must be at least 18 years of age

          -  Human leucocyte antigen (HLA) typing will be performed at high resolution (allele
             level) for the HLA-A, -B, Cw, DRB1, and -DQB1 loci. A minimum match of 5/10 is
             required. An unrelated donor search is not required for a person to be eligible for
             this study if the clinical situation dictates an urgent transplant. Clinical urgency
             is defined as 6 to 8 weeks from referral to transplant center or low likelihood of
             finding a matched, unrelated donor. The donor and recipient must be identical, as
             determined by high resolution typing, on at least one allele of each of the following
             genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. Fulfillment of this
             criterion shall be considered sufficient evidence that the donor and recipient share
             one HLA haplotype, and typing of additional family members is not required.

          -  Must have received cytotoxic chemotherapy within 3 months of the consent date
             (measured from the start date of chemotherapy)

          -  Acute leukemias (includes T lymphoblastic lymphoma) in the second or subsequent
             complete remission (CR)

          -  Burkitt's lymphoma in the second or subsequent CR

          -  Lymphoma

          -  Patients with adequate physical function as measured by the following:

               1. Heart: left ventricular ejection fraction at rest must be greater than or equal
                  to 35%, or shortening fraction greater than 25%

               2. Liver: bilirubin less than or equal to 2.5 mg/dL and alanine aminotransferase
                  (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than five
                  times the upper limit of normal

               3. Kidney: serum creatinine within normal range for age, or if serum creatinine is
                  outside the normal range for age, then kidney function (creatinine clearance or
                  glomerular filtration rate (GFR) is greater than 40 mL/min/1.73m^2

               4. Pulmonary: forced expiratory volume in one second (FEV1), forced vital capacity
                  (FVC), and carbon monoxide diffusing capacity (DLCO) greater than 50% predicted
                  (corrected for hemoglobin). If unable to perform pulmonary function tests, then
                  oxygen (O2) saturation must be greater than 92% on room air.

               5. Performance status: Karnofsky/Lansky score greater than or equal to 60%

        Exclusion Criteria:

          -  Have an HLA-matched, related, or 7 or 8/8 allele matched (HLA-A, -B, -Cw, -DRB1)
             related donor able to donate

          -  Had an autologous hematopoietic stem cell transplant in the 3 months before study
             entry

          -  Pregnant or breastfeeding

          -  Evidence of HIV infection or known HIV positive serology

          -  Current uncontrolled bacterial, viral, or fungal infection (i.e., currently taking
             medication with evidence of progression of clinical symptoms or radiologic findings)

          -  Prior allogeneic hematopoietic stem cell transplant

          -  History of primary idiopathic myelofibrosis