Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute M… (NCT03735875) | Clinical Trial Compass
TerminatedPhase 1/2
Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia
Stopped: This study was terminated early due to other competing trials, therefore did not go on to the Phase II portion of the study.
United States8 participantsStarted 2019-01-25
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of venetoclax in combination with quizartinib and how well they work in treating patients with acute myeloid leukemia that has come back or does not respond to treatment, and who are FLT3-mutation positive. Venetoclax and quizartinib 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* FLT3-ITD mutated patients with relapsed/refractory AML (up to four prior therapeutic regimens for AML i.e. up to salvage 4 AML), including patients who may have been previously exposed to prior FLT3-inhibitor/s other than quizartinib (stem cell transplant \[SCT\] or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Serum direct bilirubin =\< 1.5 x upper limit normal (ULN) (or =\< 3.0 x ULN if deemed to be elevated due to leukemia)
* Alanine aminotransferase and/or aspartate aminotransferase (aspartate transaminase) =\< 2.5 x ULN (or =\< 5.0 x ULN if deemed elevated due to leukemia)
* Subjects with documented Gilbert's Syndrome may have a total bilirubin \> 1.5 x ULN
* Potassium levels should be within institutional normal limits
* Magnesium levels should be within institutional normal limits
* Calcium (normalized for albumin) levels should be within institutional normal limits
* Adequate renal function as demonstrated by a serum creatinine =\< 1.8
* Patients must provide written informed consent
* With the exception of patients with rapidly proliferative disease, the interval from prior treatment to time of initiation of venetoclax and quizartinib administration will be at least 14 days or at least 5 half-lives (whichever is shorter) for cytotoxic/noncytotoxic agents. The half-life for the therapy …
What they're measuring
1
Maximum Tolerated Dose (MTD) as Determined by Dose Limiting Toxicity (Phase Ib)