NCT02122081 - Organ-Sparing Marrow-Targeted Irradiation Before Stem Cell Transplant in Treating Patients With High-Risk Hematologic Malignancies | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 27, 2015

Primary Completion Date

September 6, 2022

Study Completion Date

September 6, 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)de Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Interventions

RADIATION

radiation therapy

Undergo organ-sparing marrow irradiation BID on days -6 to -4

DRUG

cyclophosphamide

Given IV over 1-2 hours every 24 hours on days -3 to -2.

BIOLOGICAL

anti-thymocyte globulin

DRUG

tacrolimus

Given IV or PO

DRUG

methotrexate

Given IV

PROCEDURE

allogeneic bone marrow transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant on day 0

PROCEDURE

allogeneic hematopoietic stem cell transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant

PROCEDURE

peripheral blood stem cell transplantation

Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (1)

43210

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center, Columbus

All Listed Sponsors

lead

Sumithira Vasu

OTHER