Tacrolimus and Mycophenolate Mofetil in Preventing Graft-Versus-Host Disease in Patients Who Have Undergone Total-Body Irradiation With or Without Fludarabine Phosphate Followed by Donor Peripheral Blood Stem Cell Transplant for 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; Blastic Phase Chronic Myelogenous Leukemia; Childhood Acute Lymphoblastic Leukemia in Remission; Childhood Acute Myeloid Leukemia in Remission; Childhood Burkitt Lymphoma; Childhood Chronic Myelogenous Leukemia; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Myelodysplastic Syndromes; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Chronic Phase Chronic Myelogenous Leukemia; Contiguous Stage II Adult Burkitt Lymphoma; Contiguous Stage II Adult Diffuse Large Cell Lymphoma; Contiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Contiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Contiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Contiguous Stage II Adult Lymphoblastic Lymphoma; Contiguous Stage II Grade 1 Follicular Lymphoma; Contiguous Stage II Grade 2 Follicular Lymphoma; Contiguous Stage II Grade 3 Follicular Lymphoma; Contiguous Stage II Mantle Cell Lymphoma; Contiguous Stage II Marginal Zone Lymphoma; Contiguous Stage II Small Lymphocytic Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; de Novo Myelodysplastic Syndromes; Essential Thrombocythemia; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncontiguous Stage II Adult Burkitt Lymphoma; Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Mixed Cell Lymphoma; Noncontiguous Stage II Adult Diffuse Small Cleaved Cell Lymphoma; Noncontiguous Stage II Adult Immunoblastic Large Cell Lymphoma; Noncontiguous Stage II Adult Lymphoblastic Lymphoma; Noncontiguous Stage II Grade 1 Follicular Lymphoma; Noncontiguous Stage II Grade 2 Follicular Lymphoma; Noncontiguous Stage II Grade 3 Follicular Lymphoma; Noncontiguous Stage II Mantle Cell Lymphoma; Noncontiguous Stage II Marginal Zone Lymphoma; Noncontiguous Stage II Small Lymphocytic Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Polycythemia Vera; Post-transplant Lymphoproliferative Disorder; Previously Treated Myelodysplastic Syndromes; Primary Myelofibrosis; Prolymphocytic Leukemia; Recurrent Adult Acute Lymphoblastic Leukemia; Recurrent Adult Acute Myeloid Leukemia; 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 Acute Lymphoblastic Leukemia; Recurrent Childhood Acute Myeloid Leukemia; 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 Hairy Cell Leukemia; Refractory Multiple Myeloma; Relapsing Chronic Myelogenous Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Stage I Adult Burkitt Lymphoma; Stage I Adult Diffuse Large Cell Lymphoma; Stage I Adult Diffuse Mixed Cell Lymphoma; Stage I Adult Diffuse Small Cleaved Cell Lymphoma; Stage I Adult Immunoblastic Large Cell Lymphoma; Stage I Adult Lymphoblastic Lymphoma; Stage I Adult T-cell Leukemia/Lymphoma; Stage I Childhood Anaplastic Large Cell Lymphoma; Stage I Childhood Large Cell Lymphoma; Stage I Childhood Lymphoblastic Lymphoma; Stage I Childhood Small Noncleaved Cell Lymphoma; Stage I Chronic Lymphocytic Leukemia; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage I Grade 1 Follicular Lymphoma; Stage I Grade 2 Follicular Lymphoma; Stage I Grade 3 Follicular Lymphoma; Stage I Mantle Cell Lymphoma; Stage I Marginal Zone Lymphoma; Stage I Multiple Myeloma; Stage I Small Lymphocytic Lymphoma; Stage IA Mycosis Fungoides/Sezary Syndrome; Stage IB Mycosis Fungoides/Sezary Syndrome; Stage II Adult T-cell Leukemia/Lymphoma; Stage II Childhood Anaplastic Large Cell Lymphoma; Stage II Childhood Large Cell Lymphoma; Stage II Childhood Lymphoblastic Lymphoma; Stage II Childhood Small Noncleaved Cell Lymphoma; Stage II Chronic Lymphocytic Leukemia; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage II Multiple Myeloma; Stage IIA Mycosis Fungoides/Sezary Syndrome; Stage IIB Mycosis Fungoides/Sezary Syndrome; 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 Immunoblastic Large Cell Lymphoma; Stage III Adult Lymphoblastic Lymphoma; Stage III Adult T-cell Leukemia/Lymphoma; Stage III Childhood Anaplastic Large Cell Lymphoma; Stage III Childhood Large Cell Lymphoma; Stage III Childhood Lymphoblastic Lymphoma; Stage III Childhood Small Noncleaved Cell 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 Small Lymphocytic Lymphoma; Stage IIIA Mycosis Fungoides/Sezary Syndrome; Stage IIIB Mycosis Fungoides/Sezary Syndrome; 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 Immunoblastic Large Cell Lymphoma; Stage IV Adult Lymphoblastic Lymphoma; Stage IV Adult T-cell Leukemia/Lymphoma; Stage IV Childhood Anaplastic Large Cell Lymphoma; Stage IV Childhood Large Cell Lymphoma; Stage IV Childhood Lymphoblastic Lymphoma; Stage IV Childhood Small Noncleaved Cell 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 Small Lymphocytic Lymphoma; Stage IVA Mycosis Fungoides/Sezary Syndrome; Stage IVB Mycosis Fungoides/Sezary Syndrome; Testicular Lymphoma; Untreated Adult Acute Lymphoblastic Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia; Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid, Acute; Neoplasms; 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; Polycythemia Vera; Lymphoma, Large-Cell, Anaplastic; Leukemia, Hairy Cell; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Lymphomatoid Granulomatosis; Leukemia, Myeloid, Accelerated Phase; Lymphoma, Extranodal NK-T-Cell; Leukemia, Prolymphocytic; Intraocular Lymphoma; Myelodysplastic Syndromes; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential; Lymphoproliferative Disorders; Immunoblastic Lymphadenopathy; Syndrome; Recurrence
Intervention: fludarabine phosphate; total-body irradiation; mycophenolate mofetil; tacrolimus; peripheral blood stem cell transplantation; nonmyeloablative allogeneic hematopoietic stem cell transplantation; laboratory biomarker analysis
Intervention description: Given IV; Undergo radiotherapy; Given IV or PO; Given IV or PO; Undergo allogeneic peripheral blood stem cell transplant; Undergo allogeneic peripheral blood stem cell transplant; Correlative studies
Intervention MeSH terms: Mycophenolic Acid; Fludarabine; Fludarabine phosphate; Tacrolimus
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 150.0
Sex: All
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well tacrolimus and mycophenolate mofetil works in preventing
      graft-versus-host disease in patients who have undergone total-body irradiation (TBI) with or
      without fludarabine phosphate followed by donor peripheral blood stem cell transplant for
      hematologic cancer. Giving low doses of chemotherapy, such as fludarabine phosphate, and TBI
      before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells.
      It also stops the patient's immune system from rejecting the donor's stem cells. The donated
      stem cells may replace the patient's immune system 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:

          -  Patient must be not eligible for conventional allogeneic hematopoietic cell
             transplantation (HCT) and must have disease expected to be stable for at least 100
             days without chemotherapy; patients with hematologic malignancies treatable with HCT
             or with a B cell malignancy except those curable with autologous transplant will be
             included; patients not eligible for active disease specific protocols may be enrolled
             in this protocol; patients will include the following

          -  Diffuse large B cell non-Hodgkin lymphoma (NHL) and other aggressive lymphomas - not
             eligible for conventional myeloablative HCT or after autologous HCT

          -  Low grade NHL- with < 6 months duration of complete response (CR) between courses of
             conventional therapy

          -  Mantle cell NHL- may be treated in first CR

          -  Chronic lymphocytic leukemia (CLL) - must have either 1) failed to meet National
             Cancer Institute (NCI) Working Group criteria for complete or partial response after
             therapy with a regimen containing fludarabine phosphate (FLU) (or another nucleoside
             analog, e.g. 2-chlorodeoxyadenosine [2-CDA], pentostatin) or experience disease
             relapse within 12 months after completing therapy with a regimen containing FLU (or
             another nucleoside analog); 2) failed FLU-cyclophosphamide (CY)-Rituximab (FCR)
             combination chemotherapy at any time point; or 3) have "17p deletion" cytogenetic
             abnormality; patients should have received induction chemotherapy but could be
             transplanted in 1st CR; 4) patients with a diagnosis of CLL (or small lymphocytic
             lymphoma) or a diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or
             T-cell CLL or PLL

          -  Hodgkin lymphoma (HL) - must have received and failed frontline therapy; patients must
             have failed or were not eligible for autologous transplant

          -  Multiple myeloma (MM) - following a planned autologous transplant or equivalent
             high-dose therapy without a graft, or following a failed prior autograft

          -  Acute myeloid leukemia (AML) - must have < 5% marrow blasts at the time of transplant

          -  Acute lymphoblastic leukemia (ALL) - must have < 5% marrow blasts at the time of
             transplant

          -  Chronic myelogenous leukemia (CML) - patients will be accepted beyond first chronic
             phase (CP1) if they have received previous myelosuppressive chemotherapy or HCT, and
             have < 5% marrow blasts at time of transplant

          -  Myelodysplastic syndromes/myeloproliferative disorders (MDS/MPD) - must have received
             previous myelosuppressive chemotherapy or HCT, and have < 5% marrow blasts at time of
             transplant

          -  Waldenstrom's macroglobulinemia - must have failed 2 courses of therapy

          -  Myelosuppressive chemotherapy must be discontinued three weeks prior to conditioning
             with the exception of hydroxyurea or imatinib

          -  Patients < 12 years old must be approved by both the participating institutions'
             patient review committee such as the Patient Care Conference (PCC) at the Fred
             Hutchinson Cancer Research Center (FHCRC) and the FHCRC principal investigator

          -  Patient who refused to be treated on a conventional HCT protocol; for this inclusion
             criterion, transplants must be approved by both the participating institution's
             patient review committee such as the Patient Care Conference (PCC) at the FHCRC and
             the FHCRC principal investigators

          -  Patients with human leukocyte antigen (HLA)-matched related donors

          -  Patients with renal failure are eligible; however, patients with renal compromise
             (serum creatinine > 2.0) will likely have further compromise in renal function and may
             require hemodialysis (which may be permanent) due to the need to maintain adequate
             serum tacrolimus levels

          -  DONOR: Related donor who is HLA genotypically identical at least at one haplotype and
             may be phenotypically or genotypically identical at the allele level at HLA-A, -B, -C,
             -DRB1, and -DQB1

          -  DONOR: Donor must consent to filgrastim (G-CSF) administration and leukapheresis

          -  DONOR: Donor must have adequate veins for leukapheresis or agree to placement of
             central venous catheter (femoral, subclavian)

        Exclusion Criteria:

          -  Eligible for a high priority curative autologous transplant

          -  Patient with rapidly progressive, aggressive NHL unless in minimal disease state

          -  Patients with chronic myelomonocytic leukemia (CMML)

          -  Life expectancy severely limited by diseases other than malignancy

          -  Any current central nervous system (CNS) involvement with disease refractory to
             intrathecal chemotherapy

          -  Presence of circulating leukemic blasts (in the peripheral blood) detected by standard
             pathology for patients with AML, ALL or CML

          -  Fertile men or women unwilling to use contraceptives during and for up to 12 months
             post treatment

          -  Female patients who are pregnant or breastfeeding

          -  Human immunodeficiency virus (HIV)-positive patients

          -  Patients with active non-hematologic malignancies (except non-melanoma skin cancers);
             this exclusion does not apply to patients with non-hematologic malignancies that do
             not require therapy

          -  Patients with a history of non-hematologic malignancies (except non-melanoma skin
             cancers) currently in a complete remission, who are less than 5 years from the time of
             complete remission, and have a > 20% risk of disease recurrence; this exclusion does
             not apply to patients with non-hematologic malignancies that do not require therapy

          -  Fungal pneumonia with radiological progression after receipt of amphotericin
             formulation or mold-active azoles for greater than 1 month

          -  Karnofsky score < 50 for adult patients

          -  Lansky-Play performance score < 50 for pediatric patients

          -  Symptomatic coronary artery disease or ejection fraction < 35% or other cardiac
             failure requiring therapy (or, if unable to obtain ejection fraction, shortening
             fraction of < 26%); ejection fraction is required if age > 50 years or there is a
             history of anthracycline exposure or history of cardiac disease; patients with a
             shortening fraction < 26% may be enrolled if approved by a cardiologist

          -  Poorly controlled hypertension

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) < 30%, total lung capacity
             (TLC) < 30%, forced expiratory volume in one second (FEV1) < 30% and/or receiving
             supplementary continuous oxygen; the FHCRC principal investigator (PI) of the study
             must approve enrollment of all patients with pulmonary nodules

          -  Liver function abnormalities: Patients with clinical or laboratory evidence of liver
             disease would be evaluated for the cause of liver disease, its clinical severity in
             terms of liver function, and the degree of portal hypertension; patients will be
             excluded if they are found to have fulminant liver failure, cirrhosis of the liver
             with evidence of portal hypertension or bridging fibrosis, alcoholic hepatitis,
             esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy,
             uncorrectable hepatic synthetic dysfunction evinced 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, and
             symptomatic biliary disease

          -  Patients with active bacterial or fungal infections unresponsive to medical therapy

          -  DONOR: Age less than 12 years

          -  DONOR: Identical twin

          -  DONOR: Pregnancy

          -  DONOR: Infection with HIV

          -  DONOR: Known allergy to filgrastim (G-CSF)

          -  DONOR: Current serious systemic illness that would result in increased risk for G-CSF
             mobilization and harvest of peripheral blood stem cells (PBSC)