Two-Step Haploidentical Transplant with Radiation for Blood Cancers
This study is testing a modified way to prepare patients for a hematopoietic stem cell transplant (HSCT), which is a treatment for blood cancers like acute myeloid leukemia and acute lymphoblastic leukemia. The goal is to see if this new approach, using drugs like Fludarabine and Cyclophosphamide along with Total-Body Irradiation (TBI), can reduce treatment-related mortality (TRM). You might be eligible if you are 18 or older and have certain blood cancers. The main way we'll know if this treatment is successful is by looking at how many participants experience TRM within two years after their transplant. The current status of this study is unclear, and it plans to enroll 63 participants.
- Study design
- This is an interventional study with an unclear phase, planning to enroll 63 participants. Participants are assigned to one of two cohorts, with one group receiving radiation-based conditioning and the other chemotherapy-based conditioning.
- What's involved
- Participants will receive Fludarabine, Total-Body Irradiation, Donor Lymphocyte Infusion, Cyclophosphamide, and Tacrolimus. They will also undergo bone marrow biopsies, imaging, and blood sample collection throughout the study.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint measures treatment-related mortality at 2 years post-HSCT, suggesting follow-up for at least this duration.
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NCT05031897
Two Step Haplo With Radiation Conditioning
Recruiting
PHASE2Ages 18+InterventionalTreatmentThomas Jefferson UniversityInvestigator-initiated
~63 participants
Updated 2025-10-30 on ClinicalTrials.gov
What's tested:FludarabineTotal-Body IrradiationDonor Lymphocyte InfusionCyclophosphamideTacrolimusMycophenolate Mofetil
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience Treatment-Related Mortality (TRM)
Measured over At 2 years post hematopoietic stem cell transplant (HSCT)
Conditions
Where it's being run
1 sites across 1 statesPennsylvania1
Study leadership
- Usama Gergis, MD · PRINCIPAL_INVESTIGATOR · Thomas Jefferson University
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Radiation-based cohort diagnoses:
Acute myeloid leukemia
Acute lymphoid leukemia in remission
Myelodysplasia (MDS)
Chronic lymphocytic leukemia (CLL) with no or 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
T cell lymphoma without significant lymph node disease burden
Any hematological malignancy or dyscrasia not cited above in which HSCT is potentially curable
Any patient who has a hematological disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history. Examples are patients with previous treatment with radiation therapy precluding total-body irradiation (TBI), or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen.
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
Chemotherapy-based cohort diagnoses:
Hodgkin or non-Hodgkin lymphoma
Small lymphocytic lymphoma/CLL
Any other diagnosis in which chemotherapy is thought to be superior to radiotherapy for treatment of the disease
Hematological malignancy in patients who cannot receive \> 2 Gy radiation
Aplastic anemia and other non-malignant hematologic dyscrasias
Patients must have a donor who is one-haplotype mismatched (number of mismatches in either direction not considered)
Human leukocyte antigen (HLA) identical cohort diagnoses:
Left ventricular ejection fraction of \>= 50%
Diffusion lung capacity of oxygen \>= 50% and forced expiratory volume at 1 second \>= 50% of predicted corrected for hemoglobin
Serum bilirubin =\< 1.8
Aspartate aminotransferase or alanine aminotransferase =\< 2.5 x upper limit of normal
Creatinine clearance of \>= 60 mL/min
Patients must have adequate Karnofsky performance status (KPS) and Hematopoietic Cell Transplantation-Comorbidity Index (HCT-CI) scores:
Patients \< age 60 years must have a KPS of \>= 60% and an HCT-CI score of 5 or less
Patients aged 60 to 65 years must have a KPS of \>= 60% and an HCT-CI score of 4 or less
Patients aged 66 to 69 years must have a KPS of 90% and an HCT-CI score of 3 or less
Patients aged 70 years or more must have a KPS of 90% and an HCT-CI score of 2 or less
(Patients with greater than the allowable HCT-CI points for age can be enrolled for trial with approval of the principal investigator (PI) and at least 1 co-investigator (CI) not on the primary care team of the patient). This is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than guideline HCT-CI points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities
Patients must be willing to use contraception if they have childbearing potential
Patient or patient's guardian is able to give informed consent
Patients should have a life expectancy of \>= 6 months for reasons other than their underlying hematologic/oncologic disorder
Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Patients should not be:
Human immunodeficiency virus positive
Have active involvement of the central nervous system with malignancy. This can be documented by a normal neurological exam, magnetic resonance imaging (MRI) of the head, and/or a negative cerebral spinal fluid analysis
Pregnant or breastfeeding
What this trial measures
- Number of Participants Who Experience Treatment-Related Mortality (TRM)At 2 years post hematopoietic stem cell transplant (HSCT)
TRM is defined as death without evidence of recurrent disease in the 2 year period post HSCT. Summarized using Kaplan-Meier curves and the respective Kaplan-Meier estimates of the 2-year event rate are reported as well as their 95% confidence intervals.