Total Marrow and Lymphoid Irradiation and Chemotherapy for Acute Leukemia
Trial Summary
What is the purpose of this trial?
This phase II trial studies the safety and efficacy of total marrow and lymphoid irradiation (TMLI) in combination with two chemotherapy drugs, etoposide and cyclophosphamide, as a preparative regimen before donor stem cell transplant in treating patients with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who have failed previous therapy. Intensity-modulated radiation therapy (IMRT) uses imaging to provide a three-dimensional view of the area to be irradiated. Doctors can then shape and direct the radiation beams at the area from multiple directions while avoiding, as much as possible, nearby organs. TMLI is a method of using IMRT to direct radiation to the bone marrow. Radiation therapy is given before transplant to suppress the immune system, prevent rejection of the transplanted cells, and wipe out any remaining cancer cells. TMLI may allow a greater radiation dose to be delivered to the bone marrow as a preparative regimen before transplant while causing fewer side effects than standard radiation therapy.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that chemotherapy for controlling white blood cell counts is allowed within 14 days of starting the study.
What data supports the effectiveness of this treatment for acute leukemia?
Research shows that using a combination of high-dose etoposide, cyclophosphamide, and total body irradiation before a bone marrow transplant can improve outcomes for patients with acute leukemia. In children with less advanced disease, this approach resulted in a 68% event-free survival rate over three years, indicating good effectiveness.12345
Is the combination of total body irradiation, etoposide, and cyclophosphamide safe for use in humans?
The combination of total body irradiation, etoposide, and cyclophosphamide has been reported to be generally safe for both adults and children undergoing allogeneic bone marrow transplantation, although there is a risk of severe side effects such as fever, rash, nausea, and in rare cases, severe allergic reactions.24678
How does the treatment of Total Marrow and Lymphoid Irradiation and Chemotherapy for Acute Leukemia differ from other treatments?
This treatment is unique because it combines total marrow irradiation (TMI) with chemotherapy drugs like cyclophosphamide and etoposide, specifically targeting the bone marrow and lymphoid tissues, which may reduce side effects compared to traditional total body irradiation (TBI). It aims to improve outcomes by focusing radiation on areas most affected by leukemia, potentially offering better disease control and fewer complications.49101112
Research Team
Anthony Stein, MD
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for adults with high-risk acute lymphocytic leukemia (ALL) or acute myeloid leukemia (AML) who haven't responded to previous treatments. Participants need a compatible bone marrow donor, good physical function, and normal organ function tests. They must not be pregnant, agree to use contraception, and can't have had certain prior treatments that would conflict with the trial.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants undergo image guided total marrow and lymphoid irradiation (TMLI) on days -9 to -5
Chemotherapy
Participants receive etoposide IV on day -4 and cyclophosphamide IV on day -2
Transplant
Participants undergo allogeneic peripheral blood stem cell or bone marrow transplant on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Allogeneic Bone Marrow Transplantation
- Allogeneic Hematopoietic Stem Cell Transplantation
- Cyclophosphamide
- Etoposide
- Total Marrow Irradiation
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator