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2-Step Approach to Stem Cell Transplant in Treating Participants With Hematological Malignancies

NCT03712878 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-08-22

No results posted yet for this study

Summary

This phase II trial studies how well a 2-step approach to stem cell transplant works in treating patients with blood cancers. Giving chemotherapy and total body irradiation before a lymphocyte (white blood cell) and stem cell transplant helps stop the growth of cells in the bone marrow including normal blood-forming cells (stem cells) and cancer cells. By giving the donor cells in two steps, the dose of lymphocytes given can be tightly controlled and they can be made more tolerant to the body. When the healthy lymphocytes and 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. 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 may stop this from happening.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm

Interventions

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Donor Lymphocyte Infusion

Given IV

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo HSCT

DRUG

Tacrolimus

Given IV

DRUG

Mycophenolate Mofetil

Given IV

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • USAMA GERGIS, MD · Sidney Kimmel 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
2018-09-19
Primary Completion
2025-03-19
Completion
2025-03-19
FDA Device
Yes

Countries

  • United States

Study Locations

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 NCT03712878 on ClinicalTrials.gov