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A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity

NCT03032783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-01-29

No results posted yet for this study

Summary

This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor 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.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

PROCEDURE

Donor Lymphocyte Infusion

Undergo Donor Lymphocyte Infusion

DRUG

Cyclophosphamide

Given IV

DRUG

Tacrolimus

Given IV

DRUG

Mycophenolate Mofetil

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo Hematopoietic Stem Cell Transplantation

RADIATION

Total-Body Irradiation

Undergo Total Body Irradiation

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Usama Gergis, MD · Sidney Kimmel Comprehensive Cancer Center at 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
2017-01-31
Primary Completion
2025-12-02
Completion
2025-12-02
FDA Device
Yes

Countries

  • United States

More Related Trials

Entities

Drugs

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 NCT03032783 on ClinicalTrials.gov