Two Step Haplo With Radiation Conditioning

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.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Adult T-Cell Leukemia/Lymphoma
• Aplastic Anemia
• Chronic Lymphocytic Leukemia
• Chronic Myeloid Leukemia, BCR-ABL1 Positive
• Chronic Myelomonocytic Leukemia
• Essential Thrombocythemia
• Hematopoietic and Lymphatic System Neoplasm
• Hodgkin Lymphoma
• Multiple Myeloma
• Myelodysplastic Syndrome
• Myelofibrosis
• Myeloid Neoplasm
• Non-Hodgkin Lymphoma
• Polycythemia Vera
• Small Lymphocytic Lymphoma

Interventions

DRUG

Fludarabine

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Donor Lymphocyte Infusion

Undergo DLI

DRUG

Cyclophosphamide

Given IV

DRUG

Tacrolimus

Given IV

DRUG

Mycophenolate Mofetil

Given IV

PROCEDURE

Hematopoietic Cell Transplantation

Undergo HSCT

DRUG

Melphalan

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/ biopsy

PROCEDURE

Diagnostic Imaging

Undergo diagnostic imaging

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• Thomas Jefferson University

  lead OTHER

Principal Investigators

• Usama Gergis, MD · Thomas Jefferson University

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-25

Primary Completion

2032-04-30

Completion

2032-04-30

FDA Drug

Yes

Countries

• United States