Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid L… (NCT03724084) | Clinical Trial Compass
TerminatedPhase 1/2
Pinometostat With Standard Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and MLL Gene Rearrangement
Stopped: Other - Study agent no longer available
United States6 participantsStarted 2019-04-10
Plain-language summary
This phase Ib/II trial studies the side effects and best dose of pinometostat and how well it works with standard chemotherapy in treating patients with newly diagnosed acute myeloid leukemia and a type of genetic mutation called MLL gene rearrangement. Pinometostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in standard chemotherapy, such as daunorubicin hydrochloride and cytarabine, 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 pinometostat with standard chemotherapy may work better at treating acute myeloid leukemia.
Who can participate
Age range14 Years
SexALL
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Inclusion Criteria:
* Patients must have histologically confirmed acute myeloid leukemia by World Health Organization (WHO) criteria. Patients with treatment-related acute leukemia are eligible if they do not exceed lifetime anthracycline doses
* Presence of a cytogenetic rearrangement of KMT2A (MLL) by interphase fluorescent in-situ hybridization (FISH)
* Patients must have previously untreated (with exception of hydroxyurea for count control or all-trans retinoic acid \[ATRA\] for acute promyelocytic leukemia \[APML\] that was initially suspected but later ruled out) AML by World Health Organization (WHO) criteria. Treatment with hydroxyurea for count-control of hyperproliferative disease is permitted before and during treatment with pinometostat and chemotherapy
* Age \>=14 years at time of screening, although individual sites may further restrict age eligibility in accordance with local Institutional Review Board (IRB) and hospital policy.
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
* Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), unless elevated due to Gilbert syndrome, hemolysis, or leukemia (at the time of eligibility screening)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN, unless due to leukemia in which case \< 5 x ULN (at the time of eligibility screeni…
What they're measuring
1
Dose Limiting Toxicity (Phase Ib)
Timeframe: Up to 35 days
2
Complete Response (CR) or Complete Response With Incomplete Count Recovery (CRi) Rate