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Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

NCT02566304 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-24

Study results available
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Summary

This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.

Conditions

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia in Remission
  • Aplastic Anemia
  • Chronic Myelomonocytic Leukemia
  • Hodgkin Lymphoma
  • Indolent Non-Hodgkin Lymphoma
  • Malignant Neoplasm
  • Myelodysplastic Syndrome
  • Myeloproliferative Neoplasm
  • Plasma Cell Myeloma
  • Refractory Anemia
  • Refractory Anemia With Excess Blasts
  • Refractory Anemia With Ring Sideroblasts
  • Refractory Cytopenia With Multilineage Dysplasia
  • Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts

Interventions

DRUG

Fludarabine

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

BIOLOGICAL

T Cell-Depleted Donor Lymphocyte Infusion

Undergo DLI

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplant

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo PBSC transplant

DRUG

Tacrolimus

Given PO

DRUG

Mycophenolate mofetil

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Usama Gergis, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-13
Primary Completion
2024-02-13
Completion
2024-02-13

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566304 on ClinicalTrials.gov