Trial Summary
What is the purpose of this trial?This trial tests the best dose of sorafenib combined with busulfan and fludarabine for patients with hard-to-treat acute myeloid leukemia. Sorafenib blocks enzymes needed for cancer growth, while busulfan and fludarabine kill or stop the spread of cancer cells. Sorafenib has shown potential in early studies for treating acute myeloid leukemia.
Eligibility Criteria
Adults aged 18-70 with recurrent or unresponsive acute myeloid leukemia, suitable for donor stem cell transplant. Must have a matched sibling or unrelated donor, normal organ function tests, and agree to contraception. Excludes those with certain heart conditions, bleeding disorders, other cancers within 3 years (except some skin/bladder cancers), major surgery within the last month, and inability to take oral medication.Inclusion Criteria
Direct bilirubin less than or equal to 1 mg/dL
Alanine transaminase (ALT) less than or equal to 3 x upper limit of normal
Serum creatinine less than or equal to 1.5 x the upper limit of normal
+11 more
Exclusion Criteria
I have no other cancers except possibly treated skin, cervical, or superficial bladder cancer, or any cancer cured over 3 years ago.
My leukemia is in its first full remission and is considered low risk.
My blood pressure is high despite taking medication.
+16 more
Participant Groups
The trial is testing the effectiveness of sorafenib combined with busulfan and fludarabine in patients undergoing stem cell transplants for acute myeloid leukemia that has returned or is treatment-resistant. It aims to find the best dose of sorafenib that can block cancer growth when used alongside chemotherapy drugs.
1Treatment groups
Experimental Treatment
Group I: Treatment (sorafenib, busulfan, fludarabine, HSCT)Experimental Treatment8 Interventions
PRE-STEM CELL INFUSION: Patients receive sorafenib orally PO QD or BID on days -24 to -5, busulfan IV over 3 hours on days -20 and -13 and -6 and -3, and fludarabine IV over 1 hour on days -6 to -3 in the absence of disease progression or unacceptable toxicity.
STEM CELL INFUSION: Patients receive allogeneic HSCT IV in the absence of disease progression or unacceptable toxicity.
POST-STEM CELL INFUSION: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4, tacrolimus PO BID beginning day 5 for about 50 days, filgrastim SC on day 7 and sorafenib PO BID beginning between days +30 and +120 for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients with matched unrelated donor receive mycophenolate mofetil PO TID or IV over 2 hours TID beginning on day 5 for up to 90 days for longer.
Busulfan is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Busulfex for:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Malignant lymphoma
- Bone marrow transplantation conditioning
🇪🇺 Approved in European Union as Busulfan for:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
🇨🇦 Approved in Canada as Busulfex for:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
🇯🇵 Approved in Japan as Busulfan for:
- Chronic myeloid leukemia
- Acute myeloid leukemia
- Bone marrow transplantation conditioning
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
National Cancer Institute (NCI)Collaborator