A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial

Title

A Randomized Phase II Study to Determine the Most Promising Postgrafting Immunosuppression for Prevention of Acute GVHD After Unrelated Donor G-CSF Mobilized Peripheral Blood Mononuclear Cell (G-PBMC) Transplantation Using Nonmyeloablative Conditioning for Patients With Hematologic Malignancies A Multi-Center Trial

Lead sponsor

Fred Hutchinson Cancer Center

Phase

Phase 2

Overall status

Completed

Start date

November 30, 2004

Completion date

May 8, 2015

Enrollment

210 (actual)

Sites

11

accelerated phase chronic myelogenous leukemia, bcr-abl1 positive, adult acute lymphoblastic leukemia in remission, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with inv(16)(p13.1q22); cbfb-myh11, adult acute myeloid leukemia with t(8;21)(q22;q22); runx1-runx1t1, adult acute myeloid leukemia with t(9;11)(p22;q23); mllt3-mll, adult acute promyelocytic leukemia with t(15;17)(q22;q12); pml-rara, atypical chronic myeloid leukemia, bcr-abl1 negative, blast phase chronic myelogenous leukemia, bcr-abl1 positive, childhood acute lymphoblastic leukemia in remission, childhood acute myeloid leukemia in remission, childhood burkitt lymphoma, childhood chronic myelogenous leukemia, bcr-abl1 positive, childhood diffuse large cell lymphoma, childhood immunoblastic lymphoma, childhood myelodysplastic syndrome, myelodysplastic/myeloproliferative neoplasm, unclassifiable, previously treated myelodysplastic syndrome, 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 hodgkin lymphoma, recurrent adult immunoblastic lymphoma, recurrent adult lymphoblastic lymphoma, recurrent childhood acute lymphoblastic leukemia, recurrent childhood acute myeloid leukemia, recurrent childhood anaplastic large cell lymphoma, recurrent childhood burkitt lymphoma, recurrent childhood hodgkin lymphoma, recurrent childhood large cell lymphoma, recurrent childhood lymphoblastic lymphoma, recurrent chronic myelogenous leukemia, bcr-abl1 positive, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, refractory chronic lymphocytic leukemia, refractory plasma cell myeloma, secondary myelodysplastic syndrome, stage i adult burkitt lymphoma, stage i adult diffuse large cell lymphoma, stage i adult diffuse mixed cell lymphoma, stage i adult immunoblastic lymphoma, stage i adult lymphoblastic lymphoma, stage i childhood anaplastic large cell lymphoma, stage i childhood burkitt lymphoma, stage i childhood large cell lymphoma, stage i childhood lymphoblastic 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 small lymphocytic lymphoma, stage ii adult contiguous immunoblastic lymphoma, stage ii adult non-contiguous immunoblastic lymphoma, stage ii childhood anaplastic large cell lymphoma, stage ii childhood burkitt lymphoma, stage ii childhood lymphoblastic lymphoma, stage ii contiguous adult burkitt lymphoma, stage ii contiguous adult diffuse large cell lymphoma, stage ii contiguous adult diffuse mixed cell lymphoma, stage ii contiguous adult diffuse small cleaved cell lymphoma, stage ii contiguous adult lymphoblastic lymphoma, stage ii contiguous mantle cell lymphoma, stage ii grade 1 contiguous follicular lymphoma, stage ii grade 1 non-contiguous follicular lymphoma, stage ii grade 2 contiguous follicular lymphoma, stage ii grade 2 non-contiguous follicular lymphoma, stage ii grade 3 contiguous follicular lymphoma, stage ii grade 3 non-contiguous follicular lymphoma, stage ii non-contiguous adult burkitt lymphoma, stage ii non-contiguous adult diffuse large cell lymphoma, stage ii non-contiguous adult diffuse mixed cell lymphoma, stage ii non-contiguous adult diffuse small cleaved cell lymphoma, stage ii non-contiguous adult lymphoblastic lymphoma, stage ii non-contiguous mantle cell lymphoma, stage ii small lymphocytic lymphoma, 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 lymphoma, stage iii adult lymphoblastic lymphoma, stage iii childhood anaplastic large cell lymphoma, stage iii childhood burkitt lymphoma, stage iii childhood large cell lymphoma, stage iii childhood 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 marginal zone lymphoma, stage iii small lymphocytic lymphoma, 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 lymphoma, stage iv adult lymphoblastic lymphoma, stage iv childhood anaplastic large cell lymphoma, stage iv childhood burkitt lymphoma, stage iv childhood large cell lymphoma, stage iv childhood 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 marginal zone lymphoma, stage iv small lymphocytic lymphoma, waldenstrom macroglobulinemia