Haploidentical Donor Bone Marrow Transplant in Treating Patients With High-Risk Hematologic Cancer
Condition: Accelerated Phase Chronic Myelogenous Leukemia; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Myelodysplastic Syndromes; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; de Novo Myelodysplastic Syndromes; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hematopoietic/Lymphoid Cancer; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Peripheral T-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Multiple Myeloma; Relapsing Chronic Myelogenous Leukemia; Secondary Myelodysplastic Syndromes; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage II Multiple Myeloma; Stage III Adult Burkitt Lymphoma; Stage III Adult Diffuse Large Cell Lymphoma; Stage III Adult Diffuse Mixed Cell Lymphoma; Stage III Adult Diffuse Small Cleaved Cell Lymphoma; Stage III Adult Hodgkin Lymphoma; Stage III Adult Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Childhood Hodgkin Lymphoma; Stage III Chronic Lymphocytic Leukemia; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage III Grade 1 Follicular Lymphoma; Stage III Grade 2 Follicular Lymphoma; Stage III Grade 3 Follicular Lymphoma; Stage III Mantle Cell Lymphoma; Stage III Marginal Zone Lymphoma; Stage III Multiple Myeloma; Stage III Mycosis Fungoides/Sezary Syndrome; Stage III Small Lymphocytic Lymphoma; Stage IV Adult Burkitt Lymphoma; Stage IV Adult Diffuse Large Cell Lymphoma; Stage IV Adult Diffuse Mixed Cell Lymphoma; Stage IV Adult Diffuse Small Cleaved Cell Lymphoma; Stage IV Adult Hodgkin Lymphoma; Stage IV Adult Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Childhood Hodgkin Lymphoma; Stage IV Chronic Lymphocytic Leukemia; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IV Grade 1 Follicular Lymphoma; Stage IV Grade 2 Follicular Lymphoma; Stage IV Grade 3 Follicular Lymphoma; Stage IV Mantle Cell Lymphoma; Stage IV Marginal Zone Lymphoma; Stage IV Mycosis Fungoides/Sezary Syndrome; Stage IV Small Lymphocytic Lymphoma; Testicular Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid, Acute; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, B-Cell, Marginal Zone; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Lymphomatoid Granulomatosis; Leukemia, Myeloid, Accelerated Phase; Lymphoma, Extranodal NK-T-Cell; Intraocular Lymphoma; Myelodysplastic Syndromes; Lymphoproliferative Disorders; Immunoblastic Lymphadenopathy; Syndrome; Recurrence
Intervention: cyclophosphamide; fludarabine phosphate; tacrolimus; mycophenolate mofetil; polymerase chain reaction; fluorescence in situ hybridization; polymorphism analysis; gene expression analysis; total-body irradiation; allogeneic bone marrow transplantation; allogeneic hematopoietic stem cell transplantation
Intervention description: Given IV; Given IV; Given IV or orally; Given orally; Correlative studies; Correlative studies; Correlative studies; Correlative studies; Undergo total-body irradiation; Undergo haploidentical hematopoietic bone marrow transplantation; Undergo haploidentical hematopoietic bone marrow transplantation
Intervention MeSH terms: Mycophenolic Acid; Cyclophosphamide; Fludarabine; Fludarabine phosphate; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving fludarabine phosphate, cyclophosphamide,
      tacrolimus, mycophenolate mofetil and total-body irradiation together with a donor bone
      marrow transplant works in treating patients with high-risk hematologic cancer. Giving low
      doses of chemotherapy, such as fludarabine phosphate and cyclophosphamide, and total-body
      irradiation before a donor bone marrow transplant helps stop the growth of cancer cells by
      stopping them from dividing or killing them. Giving cyclophosphamide after transplant may
      also stop the patient's immune system from rejecting the donor's bone marrow stem cells. The
      donated stem cells may replace the patient's immune system cells and help destroy any
      remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a
      donor can also make an immune response against the body's normal cells. Giving tacrolimus and
      mycophenolate mofetil after the transplant may stop this from happening
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic myeloid leukemia (CML) in accelerated phase (AP)

          -  Acute myeloid leukemia (AML) with high-risk cytogenetics [del(5q)/-5, del(7q)/-7,
             abnormal 3q, 9q, 11q, 20q, 21q, 17p, t(6:9), t(9;22), complex karyotypes (>= 3
             abnormalities)] in complete remission (CR)1

          -  AML >= CR2; patients should have < 5% marrow blasts at the time of transplant

          -  High-risk ALL defined as: CR1 with high-risk cytogenetics; t(9;22), t(4;11), or
             hypodiploid (< 45 chromosomes) for pediatric patients; t(9;22), t(8;14), t(4;11),
             t(1;19) for adult patients; > 4 wk to achieve CR1; >= CR2 (patients should have < 5%
             marrow blasts at the time of transplant)

          -  Myelodysplastic syndromes (MDS) (>int-1 per IPSS) after >= 1 prior cycle of induction
             chemotherapy; should have < 5% marrow blasts at the time of transplant

          -  Multiple myeloma (MM) Stage II or III patients who have progressed after an initial
             response to chemotherapy or autologous hematopoietic stem cell transplantation (HSCT)
             or MM patients with refractory disease who may benefit from tandem
             autologous-nonmyeloablative allogeneic transplant

          -  Chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL) or Hodgkin's Disease
             (HD) who are ineligible for autologous HSCT or who have resistant/refractory disease
             and who may benefit from tandem autologous nonmyeloablative allogeneic transplant

          -  Patients who have received a prior allogeneic HSCT and who have either rejected their
             grafts or who have become tolerant of their grafts with no active graft-versus-host
             disease (GvHD) requiring immunosuppressive therapy

          -  DONOR: Related donors who are identical for one HLA haplotype and mismatched at the
             HLA-A, -B, -C or DRB1 loci of the unshared haplotype with the exception of single
             HLA-A, -B or -C allele mismatches

        Exclusion Criteria:

          -  Cross-match positive with donor

          -  Patients with suitably matched related or unrelated donors

          -  Patients with conventional transplant options (a conventional transplant should be the
             priority for eligible patients =< 50 yr of age who have a related donor mismatched for
             a single HLA-A, -B or DRB1 antigen)

          -  Central nervous system (CNS) involvement with disease refractory to intrathecal
             chemotherapy

          -  Presence of active, serious infection (e.g., mucormycosis, uncontrolled aspergillosis,
             tuberculosis)

          -  Karnofsky Performance Status < 60 for adult patients

          -  Lansky-Play Performance Score < 60 for pediatric patients

          -  Left ventricular ejection fraction < 35%

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) < 35% and/or receiving
             supplemental continuous oxygen

          -  Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of
             portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy,
             uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the
             prothrombin time, ascites related to portal hypertension, bacterial or fungal liver
             abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3
             mg/dL or symptomatic biliary disease

          -  Human immunodeficiency virus (HIV)-positive patients

          -  Women of childbearing potential who are pregnant (beta-HCG+) or breast feeding

          -  Fertile men and women unwilling to use contraceptives during and for 12 months
             post-transplant

          -  Life expectancy severely limited by diseases other than malignancy

          -  DONOR: Donor-recipient pairs in which the HLA-mismatch is only in the HVG direction

          -  DONOR: Cross-match positive with recipient