Sargramostim in Reducing Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplantation for Hematologic Cancer or Aplastic Anemia
Condition: Chronic Myeloproliferative Disorders; Graft Versus Host Disease; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms
MeSH terms: Lymphoma; Leukemia; Preleukemia; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Graft vs Host Disease; Syndrome
Study type: Interventional

Summary: 
      RATIONALE: Colony-stimulating factors such as sargramostim may increase the number of immune
      cells found in bone marrow or peripheral blood and may help a person's immune system recover
      from the side effects of chemotherapy or radiation therapy. Giving sargramostim to the stem
      cell donor and the patient may reduce the chance of developing graft-versus-host disease
      following stem cell transplantation.

      PURPOSE: Clinical trial to study the effectiveness of sargramostim in decreasing
      graft-versus-host disease in patients who are undergoing donor stem cell transplantation for
      hematologic cancer or aplastic anemia.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of sargramostim (GM-CSF) to mobilize CD34+ hematopoietic stem
           cells in donors and to reduce graft-vs-host disease in patients after allogeneic stem
           cell transplantation (SCT) for hematologic malignancy or aplastic anemia.

        -  Determine the safety of GM-CSF after allogeneic SCT transplantation in these patients.

      OUTLINE: This is a pilot study.

        -  Donors: Donors receive sargramostim (GM-CSF) subcutaneously (SC) once daily on days 1-6.
           Donors undergo stem cell harvest on day 7.

      Donors may undergo up to 3 apheresis procedures to reach the target stem cell dose and may
      receive additional GM-CSF prior to each collection.

        -  Patients: Patients receive conditioning therapy as per transplantation protocol RP98-15.
           Patients undergo allogeneic stem cell transplantation on day 0. Patients then receive
           GM-CSF SC once daily beginning on day 7 and continuing until blood counts recover.

      Patients are followed weekly until day 100 and then at days 180 and 360.

      PROJECTED ACCRUAL: A total of 10 patients and 10 donors will be accrued for this study.
    

Intervention name(s): sargramostim
Intervention type(s): Biological
Intervention MeSH terms: Sargramostim
Primary purpose: Supportive Care
Keywords: graft versus host disease; accelerated phase chronic myelogenous leukemia; chronic phase chronic myelogenous leukemia; primary myelofibrosis; childhood acute myeloid leukemia/other myeloid malignancies; childhood acute promyelocytic leukemia (M3); recurrent childhood acute lymphoblastic leukemia; recurrent childhood acute myeloid leukemia; recurrent childhood large cell lymphoma; recurrent childhood lymphoblastic lymphoma; recurrent childhood small noncleaved cell lymphoma; recurrent/refractory childhood Hodgkin lymphoma; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; meningeal chronic myelogenous leukemia; 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 Burkitt 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; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Burkitt lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma; recurrent adult acute lymphoblastic leukemia; recurrent adult acute myeloid leukemia; recurrent adult Hodgkin 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; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; refractory chronic lymphocytic leukemia; 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 Burkitt lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic 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 chronic lymphocytic leukemia; 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 Burkitt lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic 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 chronic lymphocytic leukemia; untreated adult acute lymphoblastic leukemia; untreated adult acute myeloid leukemia; untreated childhood acute lymphoblastic leukemia; untreated childhood acute myeloid leukemia and other myeloid malignancies; childhood chronic myelogenous leukemia; chronic eosinophilic leukemia; chronic neutrophilic leukemia; atypical chronic myeloid leukemia, BCR-ABL1 negative; myelodysplastic/myeloproliferative neoplasm, unclassifiable; noncontiguous stage II small lymphocytic lymphoma; noncontiguous stage II marginal zone lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; stage III small lymphocytic lymphoma; stage III marginal zone lymphoma; stage IV small lymphocytic lymphoma; stage IV marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12); childhood myelodysplastic syndromes