RecruitingPhase 2NCT05031897

Two Step Haplo With Radiation Conditioning

A 2 Step Approach to Haploidentical Transplant Using Radiation-Based Reduced Intensity Conditioning


Sponsor

Thomas Jefferson University

Enrollment

63 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II clinical trial evaluates whether a modified modality of conditioning reduces treatment-related mortality (TRM) in patients who undergo a hematopoietic stem cell transplant (HSCT) for a hematological malignancy. HSCT is a curative therapy for many hematopoietic malignancies, however this regimen results in higher rates of TRM than other forms of treatment. In recent years, less intense conditioning regimens with radiation and chemotherapy prior to HSCT have been developed. Radiation therapy uses high energy sources to kill cancer cells and shrink tumors while chemotherapy drugs like fludarabine and cyclophosphamide work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study evaluates whether a two-step approach with lower-intensity regimens of these treatments prior to HSCT reduces the rate of TRM.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial uses a "two-step" bone marrow transplant approach — called haploidentical (half-matched donor) transplantation — as a treatment for blood cancers. The unique method separates immune cell infusion into two steps to reduce the risk of graft-versus-host disease while still fighting the cancer. It is designed for patients who need a transplant but can't find a fully matched donor. **You may be eligible if...** - You have a blood cancer such as AML, ALL, MDS, lymphoma, multiple myeloma, or a related condition - You have a family member who is a half-matched (haploidentical) donor - Your cancer is considered potentially curable with a bone marrow transplant - You may also qualify if prior radiation or past transplants prevent you from receiving a standard high-intensity regimen **You may NOT be eligible if...** - You do not have a suitable haploidentical donor - Your cancer is too advanced or your overall health is too poor for a transplant - Your disease is not on the list of eligible diagnoses Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

Given IV

RADIATIONTotal-Body Irradiation

Undergo TBI

PROCEDUREDonor Lymphocyte Infusion

Undergo DLI

DRUGCyclophosphamide

Given IV

DRUGTacrolimus

Given IV

DRUGMycophenolate Mofetil

Given IV

PROCEDUREHematopoietic Cell Transplantation

Undergo HSCT

DRUGMelphalan

Given IV

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/ biopsy

PROCEDUREDiagnostic Imaging

Undergo diagnostic imaging

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadephia, Pennsylvania, United States

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NCT05031897


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