Rasburicase in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer or Other Disease Undergoing Donor Stem Cell Transplant
Condition: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
MeSH terms: Lymphoma; Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease; Syndrome
Intervention: busulfan; cyclophosphamide; cyclosporin-A; etoposide; methotrexate; rasburicase; sirolimus; tacrolimus; allogeneic hematopoietic stem cell transplantation; peripheral blood stem cell transplantation; total-body irradiation; fludarabine; allopurinol
Intervention description: Busulfan 3.2 mg/kg/day from day -7 to day -4 as standard of care for myeloablative (bone marrow depletion) conditioning at the investigator's discretion; Cyclophosphamide as standard of care for myeloablative conditioning at the investigator's discretion; Cyclosporin-A as standard of care for GVHD prophylaxis at the investigator's discretion; Etoposide as standard of care for myeloablative conditioning at the investigator's discretion; Methotrexate 1.5 mg/kg/day on days -3, -2, and -1 as standard of care for GVHD prophylaxis at the investigator's discretion; Rasburicase 0.20 mg/kg intravenous infusion over 30 minutes for 5 to 7 days; Sirolimus as standard of care for GVHD prophylaxis at the investigator's discretion; Tacrolimus as standard of care for GVHD prophylaxis at the investigator's discretion; Total body irradiation 13.2 Gy over 8 fractions from day -7 to day - 4 for myeloablative conditioning at the investigator's discretion; Fludarabine 40 mg/m^2/day from day -6 to day -3 as myeloablative conditioning at the investigator's discretion; Allopurinol per institutional guidelines
Intervention MeSH terms: Cyclosporine; Sirolimus; Cyclophosphamide; Busulfan; Methotrexate; Fludarabine; Etoposide; Allopurinol; Rasburicase; Tacrolimus; Cyclosporins
Phase: Phase 1
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: graft versus host disease; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; 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 Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult T-cell leukemia/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; splenic marginal zone lymphoma; Waldenström macroglobulinemia; recurrent adult acute lymphoblastic leukemia; refractory chronic lymphocytic leukemia; recurrent adult acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; 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); accelerated phase chronic myelogenous leukemia; blastic phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; previously treated myelodysplastic syndromes; primary myelofibrosis; atypical chronic myeloid leukemia, BCR-ABL1 negative; chronic eosinophilic leukemia; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; myelodysplastic/myeloproliferative neoplasm, unclassifiable; refractory hairy cell leukemia; refractory multiple myeloma; secondary acute myeloid leukemia; secondary myelodysplastic syndromes

Summary:

      RATIONALE: Rasburicase may be an effective treatment for graft-versus-host disease caused by
      a donor stem cell transplant.

      PURPOSE: This clinical trial is studying how well rasburicase works in preventing
      graft-versus-host disease in patients with hematologic cancer or other disease undergoing
      donor stem cell transplant.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Patients with hematologic malignancies for whom conventional myeloablative allogeneic
             stem cell transplantation is deemed clinically appropriate and who are eligible for
             conventional myeloablative allogeneic stem cell transplantation on treatment
             plans/protocols, including any of the following:

               -  Non-Hodgkin lymphoma or Hodgkin lymphoma (relapsed or refractory disease)

               -  Chronic lymphocytic leukemia (received more than one previous treatment regimen)

               -  Acute myelogenous or lymphoblastic leukemia (AML/ALL) (high-risk disease, in
                  first complete remission [CR1] or subsequent remission, or primary refractory
                  disease)

               -  Chronic myelogenous leukemia in tyrosine-kinase resistant chronic phase,
                  accelerated or blast phase, or primary refractory disease

               -  Myelodysplastic syndromes in International Prognostic Scoring System (IPSS)
                  high-intermediate or high-risk groups

               -  Other hematologic disorders for which allogeneic stem cell transplantation is
                  appropriate (e.g., myelofibrosis)

          -  Patients who have relapsed after standard autologous and/or allogeneic bone marrow
             transplant are eligible

          -  Must be receiving filgrastim (G-CSF)-mobilized related or unrelated donor allogeneic
             peripheral blood stem cells

               -  Patients receiving hematopoietic stem cells of any other sources such as a marrow
                  graft or umbilical cord blood will not be eligible for this study

          -  Donor must be HLA-genotypically or phenotypically 6 of 6 antigen matched (at the A, B,
             DR loci) related or unrelated

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  Patients with a "currently active" second malignancy other than non-melanoma skin
             cancers can only be registered if survival from the second malignancy is expected to
             be more than 1 year

          -  Ejection fraction ≥ 45% by either radioisotope Multiple Gated Acquisition Scan (MUGA)
             scan or Echocardiogram (ECHO)

          -  Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) ≥ 50% of predicted with no
             symptomatic pulmonary disease

          -  Mini Mental Status Exam Score ≥ 20

          -  Patients must have an expected life expectancy of at least 3 months

          -  Patients with symptomatic visceral, blood stream or nervous system opportunistic
             infection are eligible if the infection has been appropriately treated and controlled

               -  Patients with a fungal infection must have had treatment for at least one month
                  and must have proof of regression of the infection prior to enrollment

               -  Patients may be on antibiotics at the time of transplant

        Exclusion criteria:

          -  Human Immunodeficiency Virus (HIV) infection

          -  Uncontrolled diabetes mellitus

          -  Active congestive heart failure from any cause

               -  Previous history of congestive heart failure allowed

          -  Active angina pectoris

          -  Oxygen-dependent obstructive pulmonary disease

          -  Failure to demonstrate adequate compliance with medical therapy and follow-up

          -  Known history of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency or history of
             hemolysis indicative of G6PD deficiency

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics