Study on Total Marrow and Lymphoid Irradiation and Chemotherapy Before Donor Stem Cell Transplant for High-Risk Acute Leukemia
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT02094794
This clinical trial is testing a new treatment approach using targeted radiation and chemotherapy before a donor stem cell transplant in patients with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have not responded to previous treatments.
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of using total marrow and lymphoid irradiation (TMLI) combined with chemotherapy drugs etoposide and cyclophosphamide before a donor stem cell transplant. This approach aims to better prepare the body by targeting the bone marrow with radiation, which may help reduce side effects compared to standard radiation therapy. The treatment is designed to suppress the immune system, prevent rejection of the transplanted cells, and eliminate remaining cancer cells.
Description
The main goal of this study is to see if the combination of TMLI, etoposide, and cyclophosphamide can help patients with high-risk acute leukemia live longer without the cancer coming back. Researchers will also look at overall survival rates, the chance of cancer returning, and any side effects or complications from the treatment.
Patients will receive image-guided TMLI over several days, followed by intravenous chemotherapy with etoposide and cyclophosphamide. After this preparative treatment, patients will undergo a donor stem cell transplant.
Participants will be monitored for five years after completing the treatment to track their health and any long-term effects.
Eligibility Criteria
Inclusion Criteria
- Ability and willingness to sign informed consent (or use a legally authorized representative if needed).
- Meeting with the transplant team to discuss risks, benefits, and alternative treatments.
- Good overall health with a performance status of 70% or higher.
- Diagnosed with high-risk acute lymphocytic leukemia or acute myeloid leukemia that has not responded to initial treatments or has relapsed.
- Have a suitable donor who is a close genetic match, either a sibling or an unrelated donor with specific matching criteria.
- At least 14 days since the last chemotherapy treatment before starting the study treatment.
- Acceptable liver and kidney function based on specific blood tests.
- Women of childbearing potential must have a negative pregnancy test.
- Adequate lung and heart function as determined by specific tests.
- Agreement to use effective contraception during the study and for six months after.
- Donor eligibility will be assessed according to standard procedures.
Exclusion Criteria
- Previous stem cell transplant.
- Prior radiation therapy that prevents the use of TMLI.
- Plans to receive other investigational treatments during the trial.
- Uncontrolled illness or active infection.
- Allergic reactions to similar drugs as etoposide.
- Other active cancers, except localized ones.
- Psychological or medical conditions that make the transplant unsafe.
- Women planning to become pregnant or breastfeed during the trial.
- Inability to comply with study monitoring requirements.
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