Phase 2
Completed N=35
Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
Source: ClinicalTrials.gov NCT02566304 ↗Enrolled (actual)
35
Serious AEs
28.6%
Results posted
Mar 2025
Primary outcomePrimary: Overall Survival (OS) — 74 percentage of participants
Summary
This clinical trial studies the use of reduced intensity chemotherapy and radiation therapy before donor stem cell transplant in treating patients with hematologic malignancies. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine phosphate, before a donor stem cell transplant may help stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Reducing the intensity of the chemotherapy and radiation may also reduce the side effects of the donor stem cell transplant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
74 | — |
| SECONDARY Relapse Related Mortality (RRM) |
13 | — |
| SECONDARY Non-Relapse Mortality (NRM) |
16 | — |
| SECONDARY Incidence and Severity of GVHD |
27 | — |
| SECONDARY Engraftment Rates |
97 | — |
| SECONDARY Lymphoid Reconstitution |
10 | — |
Eligibility Criteria
Inclusion Criteria
- Patients treated on this study will have:
- Acute myeloid leukemia in morphologic complete remission (CR) not requiring treatment for their disease for 4 weeks
- A history of acute myeloid leukemia (AML) with = 45%
- DLCO (diffusing capacity of the lung for carbon monoxide) >= 45% of predicted corrected for hemoglobin, FEV-1 (forced expiratory volume at 1 second) >= 50% of predicted
- Serum bilirubin = = 60 mL/min
- HCT-CI/age score = = 90% patients older than 70 years, KPS >= 80% patients younger than 70 years
- Patients must be willing to use contraception if they have childbearing potential
Exclusion Criteria
- Performance status 5 points (patients with greater than 5 points will be allowed for trial with approval of the principal investigator and the co-principal investigator or his designee; this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than HCT-CI 5 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)
- A diagnosis of chronic myelomonocytic leukemia (CMML), unless in morphologic CR
- Human immunodeficiency virus (HIV) positive
- Active involvement of the central nervous system with malignancy
- Inability to obtain informed consent from patient or surrogate
- Pregnancy
- Patients with life expectancy of =< 6 months for reasons other than their underlying hematologic/oncologic disorder
- Patients who have received alemtuzumab or antithymocyte globulin within 8 weeks of the transplant admission; the absence of these therapies in the medical record will serve as documentation that they were not given
- Patients with evidence of another malignancy, exclusive of a skin cancer that requires only local treatment, should not be enrolled on this protocol
Data sourced from ClinicalTrials.gov (NCT02566304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.