Chemoradiotherapy + Stem Cell Transplant for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a combination of chemotherapy, radiation therapy, and stem cell transplants to treat blood cancers such as AML (Acute Myeloid Leukemia) and ALL (Acute Lymphoblastic Leukemia). The goal is to halt cancer growth and prevent the immune system from rejecting new stem cells, aiding in the production of healthy blood cells. The trial involves drugs like fludarabine phosphate and melphalan, along with helical tomotherapy, a type of targeted radiation. Suitable participants have confirmed blood cancer diagnoses and can remain still for about 30 minutes during treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that each component of this treatment has been studied for safety. Fludarabine phosphate, an FDA-approved drug for certain blood cancers, can sometimes cause infections, with up to 67% of these infections resulting from unusual germs. Melphalan, another chemotherapy drug used before stem cell transplants, frequently causes low blood cell counts, a common side effect in cancer treatments.
Helical tomotherapy, a type of radiation therapy, has been found safe in other cancer studies and has shown survival benefits in some cases, such as mesothelioma, a cancer affecting the lung lining. Using a donor's stem cells, known as allogeneic hematopoietic stem cell transplantation, is generally safe but carries some risks. These include a small chance of serious complications for the donor and the possibility of cancer returning or a new cancer developing for the patient.
While each part of the treatment has known side effects, the trial aims to manage and balance these risks to effectively stop cancer.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment combination because it brings together advanced techniques in fighting blood cancers. Unlike standard treatments that typically involve chemotherapy or radiation alone, this approach integrates Fludarabine Phosphate and Melphalan with helical tomotherapy, a precise form of radiation therapy that targets tumors more accurately, minimizing damage to healthy tissues. Additionally, the inclusion of an allogeneic stem cell transplant offers the potential for a more robust immune response against cancer cells. This innovative combination aims to enhance efficacy while reducing side effects, which is a significant advancement over existing therapies.
What evidence suggests that this trial's treatments could be effective for blood cancers?
Research has shown that the combination of treatments in this trial—fludarabine phosphate, melphalan, and helical tomotherapy—offers promising results for blood cancers. Participants will receive these treatments as part of the preparative regimen. Fludarabine phosphate has been effective, with over 80% of patients achieving remission in past studies. Melphalan is known for its tumor-fighting ability and has successfully controlled the disease with manageable side effects. Helical tomotherapy has demonstrated good results in controlling the disease and improving survival, with fewer side effects compared to standard treatments. After these therapies, participants will undergo allogeneic hematopoietic stem cell transplantation, which can potentially cure blood-related cancers. Overall, these treatments have shown significant promise in fighting blood cancers, based on existing research.678910
Who Is on the Research Team?
Joseph Rosenthal, MD
Principal Investigator
City of Hope Medical Center
Are You a Good Fit for This Trial?
This trial is for patients with certain blood cancers like AML, high-risk MDS, or ALL. They must be able to lie still in a body cast for treatment sessions and have good heart, lung, liver, and kidney function. Excluded are those with specific leukemia types (AUL), prior extensive radiation therapy, HIV infection, uncontrolled infections or serious recent infections.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preparative Regimen
Participants receive fludarabine phosphate IV on days -7 to -3, melphalan IV on day -2, and undergo helical tomotherapy twice daily on days -7 to -4
Transplantation
Participants undergo allogeneic hematopoietic stem cell transplantation on day 0
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Allogeneic Hematopoietic Stem Cell Transplantation
- Fludarabine Phosphate
- Helical Tomotherapy
- Melphalan
Fludarabine Phosphate is already approved in United States, European Union, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Acute myeloid leukemia
- Chronic lymphocytic leukemia
- Non-Hodgkin's lymphoma
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator