Donor T Cells After Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Condition: Accelerated Phase Chronic Myelogenous Leukemia; 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 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; Cutaneous B-cell Non-Hodgkin Lymphoma; de Novo Myelodysplastic Syndromes; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Previously Treated Myelodysplastic Syndromes; 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; Relapsing Chronic Myelogenous Leukemia; Secondary Myelodysplastic Syndromes; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; T-cell Large Granular Lymphocyte Leukemia; Testicular Lymphoma; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Leukemia; Leukemia, Myeloid; 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; Hematologic Neoplasms; 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; Leukemia, Hairy Cell; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Lymphomatoid Granulomatosis; Leukemia, Myeloid, Accelerated Phase; Lymphoma, Extranodal NK-T-Cell; Intraocular Lymphoma; Leukemia, Large Granular Lymphocytic; Myelodysplastic Syndromes; Lymphoproliferative Disorders; Immunoblastic Lymphadenopathy; Syndrome; Recurrence
Intervention: therapeutic allogeneic lymphocytes; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: All
Minimum age: 14 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This pilot phase II trial studies how well giving donor T cells after donor stem cell
      transplant works in treating patients with hematologic malignancies. In a donor stem cell
      transplant, the donated stem cells may replace the patient's immune cells and help destroy
      any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T
      cells (donor lymphocyte infusion) after the transplant may help increase this effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  INCLUSION CRITERIA PRIOR TO TRANSPLANT:

          -  The clinical trial will be offered to all high risk (defined 3 below) patients with
             hematologic malignancies who require stem cell transplants as part of their standard
             of care using matched related or unrelated donors

          -  Patients with high risk myeloid or lymphoid malignancies at stem cell transplant
             following American Society for Blood and Marrow Transplantation (ASBMT) criteria,
             including but not limited to conditions listed; these criteria apply BEFORE
             cyto-reductive therapy given within 28 days of planned conditioning:

               -  Refractory acute myelogenous or lymphoid leukemia

               -  Relapsed acute myelogenous or lymphoid leukemia

               -  Myelodysplastic syndromes with 5% or more blasts

               -  Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently,
                  or second accelerated phase

               -  Recurrent or refractory malignant lymphoma or Hodgkin's disease with less than a
                  partial response at transplant

          -  High risk chronic lymphocytic leukemia defined as no response or stable disease to the
             most recent treatment regimen

          -  DONORS: Matched related or unrelated donor stem cell transplant (SCT) matched at human
             leukocyte antigen (HLA) A- B, C, and DRB1 by molecular methods; 7 of 8 matched donor
             acceptable for related donors

          -  T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least 30
             mg of alemtuzumab total in the conditioning regimen

          -  Immune suppression; planned post-transplant immune suppression should include
             tacrolimus or cyclosporin monotherapy (i.e., calcineurin inhibitor or CN) for
             alemtuzumab regimens and a second immune suppressant for ATG treated patients; other
             agents may be used if CN intolerance or toxicity occurs post-transplant

          -  Zubrod performance status (PS) 0-2 or equivalent Karnofsky PS

          -  Eligible for allogeneic transplant in the treating physicians' judgment and by
             institutional standards

          -  ELIGIBILITY TO RECEIVE DLI POST-TRANSPLANT:

          -  Donor lymphocytes available or able to be collected

          -  No evidence of disease by standard morphology; minimal residual disease or molecular
             evidence of disease will not exclude

          -  Absolute neutrophil count >= 500/μl

          -  Platelet count >= 20,000/μl without transfusion for 7 days

          -  Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
             transaminase (SGPT) =< 5 x upper limit of normal (ULN)

          -  Bilirubin =< 3 x ULN

          -  No evidence of grade II or higher acute GVHD or chronic GVHD at initiation of first
             DLI

          -  No systemic corticosteroids or immunosuppressive drugs (topical acceptable);
             replacement steroids for adrenal insufficiency are not excluded

        Exclusion Criteria:

          -  EXCLUSION CRITERIA PRIOR TO TRANSPLANT:

          -  Pregnant or lactating females

          -  Hepatitis B with positive viral load prior to transplant conditioning or hepatitis C
             virus

          -  Human immune deficiency virus

          -  Psychiatric illness that may make compliance to the clinical protocol unmanageable or
             may compromise the ability of the patient to give informed consent

          -  Creatinine >= 2.0 mg/dL

          -  SGOT and SGPT >= 5 x ULN; liver biopsy preferred for such patients

          -  Bilirubin >= 3 x ULN (unless Gilbert's syndrome)

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) < 50% corrected for
             hemoglobin

          -  Left ventricular ejection fraction or shortening fraction < 40%

          -  Unlikely to be able to procure additional donor lymphocytes