Actively Recruiting
Two Step Haplo With Radiation Conditioning
Led by Thomas Jefferson University · Updated on 2025-10-30
63
Participants Needed
1
Research Sites
544 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Two Step Haplo With Radiation Conditioning
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with hematologic malignancy or dyscrasia such as acute myeloid leukemia, acute lymphoid leukemia in remission, myelodysplasia, chronic lymphocytic leukemia with minimal lymph node involvement, multiple myeloma, chronic myeloid leukemia, myelofibrosis, myeloid malignancy not otherwise specified, chronic myelomonocytic leukemia, essential thrombocytopenia or polycythemia vera, T cell leukemia or lymphoma without significant lymph node burden, or other potentially curable hematological diseases
- Have a donor who is one-haplotype mismatched (radiation-based or chemotherapy-based cohorts) or HLA identical related donor (for HLA identical cohort)
- Left ventricular ejection fraction of 50% or higher
- Lung function with diffusion capacity of oxygen and forced expiratory volume at 1 second of 50% or higher of predicted values
- Serum bilirubin of 1.8 or less
- Aspartate aminotransferase or alanine aminotransferase less than or equal to 2.5 times the upper limit of normal
- Creatinine clearance of 60 mL/min or higher
- Adequate Karnofsky performance status and Hematopoietic Cell Transplantation-Comorbidity Index scores based on age group
- Willingness to use contraception if of childbearing potential
- Able to provide informed consent
- Life expectancy of 6 months or more for reasons other than underlying hematologic/oncologic disorder
You will not qualify if you...
- Evidence of another malignancy requiring more than local treatment for skin cancer
- Human immunodeficiency virus (HIV) positive
- Active central nervous system involvement with malignancy, confirmed by neurological exam, MRI, or cerebrospinal fluid analysis
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadephia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
U
Usama Gergis, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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