A Phase 1/2 interventional study of Enasidenib and Venetoclax in Acute Myeloid Leukemia, Relapsed Cancer and Refractory Cancer, sponsored by University Health Network, Toronto. Terminated at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by University Health Network, Toronto · Phase 1/2, Interventional, and Treatment
The purpose of this research study is to see how safe and tolerable, and to find the highest or best dose, of an investigational combination of drugs called enasidenib and venetoclax, in patients with relapsed (the cancer has come back) or refractory (the cancer does not respond or have stopped responding to treatment) acute myeloid leukemia (AML, a type of blood cancer). This study will also see how useful the combination of enasidenib and venetoclax is in the treatment of patients with relapsed or refractory AML.
This study will have two parts: Phase 1b and Phase 2. The part that patients may participate in will depend on when they join the study.
In the phase 1b portion of the study, small groups participants will receive increasing doses of venetoclax in combination with a flat dose of enadisenib until the highest dose or best dose of venetoclax that is safe and tolerable in combination with enadisenib is found.
In the phase 2 portion of the study, an additional group of participants will receive the highest or best dose of venetoclax found in the Phase 1b portion of the study with a flat dose of enadisenib to see how useful the combination is in treating relapsed or refractory acute myeloid leukemia (AML).
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Enasidenib and venetoclax will be taken by mouth (orally), once a day, every day, continuously. Every 28-day period will be called a cycle. Participants will start venetoclax alone on Cycle 1 Day 1 and continue the study drug alone until Day 15. On Day 15, participants will take enasidenib and venetoclax together and will continue to take the combination of study drugs until intolerable side effects or disease worsening.
Drug: Enasidenib · Drug: Venetoclax
Enasidenib is a drug that blocks a protein called isocitrate dehydrogenase (IDH) 2 from working. The family of IDH proteins have been indicated in the development of leukemia. By blocking IDH2, enasidenib may help stop cancer cells from growing. It is believed that the drug may be more useful in patients with a change (mutation) in their IDH 2 protein. The IDH2 gene (substances in the body that contain instructions for the proper development and function of cells) makes IDH2 proteins. As such, only patients with IDH 2 mutated gene are eligible for this study. Enasidenib is currently approved for the treatment of IDH2 mutated AML.
Also known as: IDHIFA
Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells. Venetoclax is currently approved for the treatment of type of blood cancer called chronic lymphocytic leukemia (CLL) who have received prior treatment.
Also known as: VENCLEXTA
Overall response rate (ORR)
Time frame: 3 years
Dose Limiting Toxicity
Time frame: 28 days
Maximum tolerated dose or Recommended Phase 2 Dose
Dose indicated by the mTPI decision
Time frame: 3 years
Duration of Response
The time from the date of first response until progression, relapse, death, or last follow-up.
Time frame: 3 years
Overall Survival
The first day of treatment until death or last contact.
Time frame: 3 years
Event Free Survival
The number of days from the first day of treatment to the date of earliest evidence of relapse or progression, subsequent treatment other than stem cell transplant while in response, or death, or date of last disease assessment.
Time frame: 3 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto