NCT01384513 - A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 4, 2011

Primary Completion Date

November 13, 2020

Study Completion Date

November 16, 2022

Conditions

Adult Acute Lymphoblastic Leukemia in RemissionAdult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult 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 LymphomaAplastic AnemiaChildhood Acute Lymphoblastic Leukemia in RemissionChildhood Acute Myeloid Leukemia in RemissionChildhood Myelodysplastic SyndromesChronic Eosinophilic LeukemiaChronic Myelomonocytic LeukemiaChronic Neutrophilic LeukemiaEssential ThrombocythemiaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueJuvenile Myelomonocytic LeukemiaMastocytosisMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiableNodal Marginal Zone B-cell LymphomaPolycythemia VeraPreviously Treated Myelodysplastic SyndromesPrimary MyelofibrosisRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Hodgkin LymphomaRecurrent Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRecurrent Cutaneous T-cell Non-Hodgkin LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaRecurrent/Refractory Childhood Hodgkin LymphomaRefractory AnemiaRefractory Anemia With Ringed SideroblastsRefractory Hairy Cell LeukemiaRefractory Multiple MyelomaSecondary Myelodysplastic SyndromesSplenic Marginal Zone LymphomaT-cell Large Granular Lymphocyte LeukemiaWaldenström Macroglobulinemia

Interventions

DRUG

Fludarabine

Given IV

DRUG

Busulfan

Given IV

RADIATION

Total Body Irradiation (TBI)

2 Gy administered as part of the conditioning regimen

BIOLOGICAL

Donor Lymphocyte Infusion (DLI)

Undergo DLI

DRUG

Cyclophosphamide (CY)

Given IV

DRUG

Tacrolimus

Given IV or PO

DRUG

Mycophenolate mofetil

Given IV

DEVICE

Allogeneic hematopoietic stem cell transplantation

Undergo CD34+ allogeneic PBSCT

PROCEDURE

Peripheral blood stem cell transplantation (PBSCT)

Undergo CD34+ allogeneic PBSCT

Trial Locations (1)

19107

Thomas Jefferson University, Philadelphia

All Listed Sponsors

lead

Sidney Kimmel Cancer Center at Thomas Jefferson University

OTHER