Chemotherapy + Stem Cell Transplant for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the side effect of busulfan, fludarabine phosphate, and post-transplant cyclophosphamide in treating patients with blood cancer undergoing donor stem cell transplant. Drugs used in chemotherapy, such as busulfan, fludarabine phosphate and cyclophosphamide work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy such as busulfan and fludarabine phosphate before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Giving cyclophosphamide after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the chemotherapy and stem cell transplant treatment with Busulfan and Fludarabine differ from other treatments for blood cancers?
What data supports the effectiveness of the treatment involving Busulfan, Cyclophosphamide, and Fludarabine Phosphate for blood cancers?
Research shows that using Busulfan with Fludarabine or Cyclophosphamide in stem cell transplants can be effective for blood cancers like leukemia, with studies indicating good survival rates and manageable side effects. For example, one study found that a combination of Fludarabine and Busulfan resulted in a 71% overall survival rate in leukemia patients.12567
Who Is on the Research Team?
Uday R. Popat
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with high-risk blood cancers like various leukemias, lymphomas, and myeloma. They should have a poor prognosis without transplant therapy and can be in remission or relapsed. Participants need functioning major organs, no active hepatitis B/C or HIV, not pregnant nor breastfeeding, willing to use contraception if applicable, and must have a suitable donor for stem cell transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Chemotherapy and Transplantation
Patients receive busulfan, fludarabine phosphate, and cyclophosphamide, followed by stem cell transplantation
Post-Transplantation Treatment
Patients receive cyclophosphamide and immunosuppressive therapy with tacrolimus and mycophenolate mofetil
Follow-up
Participants are monitored for safety, effectiveness, and incidence of graft versus host disease
What Are the Treatments Tested in This Trial?
Interventions
- Busulfan
- Cyclophosphamide
- Fludarabine Phosphate
Busulfan is already approved in United States, European Union, Canada, Japan for the following indications:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Malignant lymphoma
- Bone marrow transplantation conditioning
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator