IM-TMI + Chemotherapy for AML and MDS
Trial Summary
Will I have to stop taking my current medications?
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.
What data supports the effectiveness of the treatment IM-TMI + Chemotherapy for AML and MDS?
Research shows that adding total body irradiation (TBI) to a regimen with fludarabine and busulfan significantly reduces relapse rates and improves overall survival in patients with acute myelogenous leukemia (AML). Additionally, targeted marrow irradiation (TMI) with fludarabine and busulfan has shown promising survival rates in patients with high-risk blood cancers.12345
Is the treatment of IM-TMI + Chemotherapy for AML and MDS generally safe in humans?
Research shows that using lower doses of total body irradiation (TBI) and chemotherapy can reduce toxicity and non-relapse mortality in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Substituting TBI with treosulfan in certain regimens has been found to be safer for elderly patients or those with severe health issues. Additionally, using busulfan as an alternative to TBI has been evaluated for its effectiveness and safety, showing potential as a less toxic option.13467
What makes the IM-TMI + Chemotherapy treatment unique for AML and MDS?
The IM-TMI + Chemotherapy treatment is unique because it combines intensity-modulated total marrow irradiation (TMI) with chemotherapy drugs like busulfan and fludarabine, which may allow for targeted radiation to the bone marrow while minimizing damage to other tissues. This approach aims to reduce toxicity and improve outcomes compared to traditional total body irradiation (TBI) regimens.248910
What is the purpose of this trial?
The study is a Phase II clinical trial. Patients will receive intensity modulated total marrow irradiation (TMI) at a dose of 9 Gy with standard myeloablative fludarabine/ i.v. targeted busulfan (FluBu) conditioning prior to allogeneic hematopoietic stem cell transplant (HSCT).
Research Team
Damiano Rondelli, MD
Principal Investigator
University of Illinois at Chicago
Eligibility Criteria
This trial is for adults aged 18-65 with high-risk Acute Myeloid Leukemia (AML) or Myelodysplastic Syndromes (MDS), including those with specific genetic mutations, poor response to prior treatments, or severe blood cell shortages. Participants need a compatible stem cell donor and must be in relatively good health without serious heart, liver, lung conditions, active infections like hepatitis or HIV, and not pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Conditioning
Patients receive fludarabine, busulfan, and TMI as part of the conditioning regimen before stem cell transplantation
Transplantation
Stem cell product is infused according to BMT unit policy
Post-transplant Follow-up
Participants are monitored for safety and effectiveness after transplantation with evaluations at specified intervals
Treatment Details
Interventions
- Busulfan
- Fludarabine
- Tacrolimus
- Total Marrow Irradiation
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?
University of Illinois at Chicago
Lead Sponsor