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COMPLETED
NCT01384513
PHASE2

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

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

View on ClinicalTrials.gov

Summary

This phase II trial studies how well reduced intensity donor stem cell transplant works in treating patients with hematologic malignancies. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving tacrolimus and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them. Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.

Official title: A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2011-08-04

Completion Date

2022-11-16

Last Updated

2026-04-15

Healthy Volunteers

No

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

Locations (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, United States