Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute … (NCT01578109) | Clinical Trial Compass
CompletedPhase 1
Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia
United States51 participantsStarted 2012-01-13
Plain-language summary
This pilot clinical trial studies the side effects of sorafenib tosylate before and after donor bone marrow transplantation in treating patients with acute myeloid leukemia. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Acute myeloid leukemia with a FLT3-internal tandem duplication (ITD) who are in a complete remission or partial remission (less than 10% blasts in marrow) as documented by bone marrow biopsy and who plan to undergo a bone marrow transplantation
* Patients who have had count recovery (absolute neutrophil count \[ANC\] \> 500,000/mm\^3; non transfused platelet count over 30,000/mm\^3) and are at least 30 days after induction and/or transplantation but no more than 120 days post transplant
* Patients may have received any prior therapy deemed necessary for induction of remission except for patients whom have progressed while on sorafenib; patients who have responded to sorafenib previously are eligible for enrollment on the protocol
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Life expectancy of greater than four months
* Total bilirubin less than 2 x upper limit of normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional upper limit of normal
* Creatinine =\< 1.5 x upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x upper limit of normal
* The effects of sorafenib on the developing human fetus are unknown; for this reason and because tyrosine kinase inhibiting agents are known to be teratogenic, women of child-be…
What they're measuring
1
Proportion of patients removed from the study in each cohort due to toxicity