Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Condition: Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Aplastic Anemia; Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Chronic Myelomonocytic Leukemia; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Lymphoblastic Lymphoma; Myelodysplastic Syndrome; Myeloproliferative Neoplasm; Plasma Cell Myeloma; Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma; Recurrent Hodgkin Lymphoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Therapy-Related Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Multiple Myeloma; Neoplasms, Plasma Cell; Leukemia, Myeloid, Acute; Preleukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Leukemia, Myeloid, Chronic-Phase; Blast Crisis; Myelodysplastic Syndromes; Myeloproliferative Disorders; Anemia, Aplastic; Syndrome; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot phase I trial studies the side effects of engineered donor stem cell transplant in
      treating patients with hematologic malignancies. Sometimes the transplanted cells from a
      donor can make an immune response against the body's normal cells (called graft-versus-host
      disease). Using T cells specially selected from donor blood in the laboratory for transplant
      may stop this from happening.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To assess the safety of a modified peripheral blood (PB) graft for haploidentical
      transplantation, obtained by using depletion of naive, cluster of differentiation (CD)45RA+ T
      cells.

      SECONDARY OBJECTIVES:

      I. To estimate the proportion of patients with engraftment/graft failure. II. To determine
      the day 100 and 6 month non-relapse mortality (NRM). III. To estimate the cumulative
      incidence of grade 2-4 and 3-4 acute graft versus (vs.) host disease (aGVHD).

      IV. To assess the rate of chronic GVHD within the first year post transplantation.

      V. To assess immune reconstitution and the incidence of infectious episodes. VI. To assess
      disease response, disease-free survival (DFS) and overall survival (OS) after
      transplantation.

      VII. To compare results with a retrospective cohort of patients treated with bone marrow
      graft on protocol 2009-0266.

      OUTLINE:

      Patients receive melphalan intravenously (IV) over 30 minutes on day -6 and fludarabine
      phosphate IV over 1 hour on days -6 to -3. Patients undergo total-body irradiation (TBI) on
      day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also
      receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive
      tacrolimus IV for 2 weeks and orally (PO) for at least 4 months. Beginning on day 7, patients
      receive filgrastim subcutaneously (SC) daily. Patients with CD20 positive lymphoma may
      receive rituximab IV on days -13, -6, 1, and 8.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): Cyclophosphamide; Filgrastim; Fludarabine Phosphate; Laboratory Biomarker Analysis; Melphalan; Peripheral Blood Stem Cell Transplantation; Rituximab; Tacrolimus; Total-Body Irradiation
Intervention type(s): Drug; Biological; Drug; Other; Drug; Procedure; Biological; Drug; Radiation
Intervention description(s): Given IV; Given SC; Given IV; Correlative studies; Given IV; Undergo CD45RA depleted peripheral blood stem cell transplantation; Given IV; Given IV or PO; Undergo TBI
Other intervention name(s): (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CTX; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamide Monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cyclostine; Cytophosphan; Cytophosphane; Cytoxan; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; G-CSF; Neupogen; r-metHuG-CSF; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; rG-CSF; Tevagrastim; 2-F-ara-AMP; 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-; Beneflur; Fludara; SH T 586; Alanine Nitrogen Mustard; CB-3025; L-PAM; L-Phenylalanine Mustard; L-Sarcolysin; L-Sarcolysin Phenylalanine mustard; L-Sarcolysine; Melphalanum; Phenylalanine Mustard; Phenylalanine Nitrogen Mustard; Sarcoclorin; Sarkolysin; WR-19813; PBPC transplantation; PBSCT; Peripheral Blood Progenitor Cell Transplantation; Peripheral Stem Cell Support; Peripheral Stem Cell Transplant; Peripheral Stem Cell Transplantation; ABP 798; BI 695500; C2B8 Monoclonal Antibody; Chimeric Anti-CD20 Antibody; CT-P10; IDEC-102; IDEC-C2B8; IDEC-C2B8 Monoclonal Antibody; MabThera; Monoclonal Antibody IDEC-C2B8; PF-05280586; Rituxan; Rituximab ABBS; Rituximab Biosimilar ABP 798; Rituximab Biosimilar BI 695500; Rituximab Biosimilar CT-P10; Rituximab Biosimilar GB241; Rituximab Biosimilar IBI301; Rituximab Biosimilar JHL1101; Rituximab Biosimilar PF-05280586; Rituximab Biosimilar RTXM83; Rituximab Biosimilar SAIT101; rituximab biosimilar TQB2303; rituximab-abbs; RTXM83; Truxima; FK 506; Fujimycin; Hecoria; Prograf; Protopic; TBI; Total Body Irradiation; Whole Body Irradiation; Whole-Body Irradiation
Intervention MeSH terms: Cyclophosphamide; Melphalan; Mechlorethamine; Nitrogen Mustard Compounds; Rituximab; Fludarabine; Fludarabine phosphate; Antineoplastic Agents, Immunological; Tacrolimus; Antibodies; Immunoglobulins; Antibodies, Monoclonal; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment