Acute Myeloid Leukemia Clinical Trial
Official title:
Phase Ib/II Study of IDH2 Inhibitor Enasidenib in Combination With BCL2 Inhibitor Venetoclax in Patients With IDH2-Mutated Myeloid Malignancies (ENAVEN-AML)
Verified date | January 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 27 |
Est. completion date | October 26, 2023 |
Est. primary completion date | October 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Eastern Cooperative Oncology Group (ECOG) performance score of =2 - IDH2 (R140 or IDH R172) mutated AML disease status as determined by local laboratory - Relapsed and/or refractory acute myeloid leukemia (AML). Treatment-naïve patients who are not eligible for standard induction chemotherapy or high-risk myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN) may also be eligible. - Adequate hepatic function - Adequate renal function - Willing and able to provide informed consent - In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic and non-cytotoxic (immunotherapy) agents Exclusion Criteria: - Known allergy or hypersensitivity to enasidenib or venetoclax - Previously received either an IDH2 inhibitor or BCL2 inhibitor - With any uncontrolled clinically significant medical conditions - The use of other chemotherapeutic agents or anti-leukemic agents, radiotherapy or other investigational therapy is not permitted during study with exceptions - Receiving concomitant treatment with strong cytochrome P450 2A (CYP3A4) inhibitors within 3 days of start of study therapy - Receiving concomitant strong CYP3A inducers (avasimibe, carbamazepine, phenytoin, rifampin, rifabutin, St. John's Wort) within 3 days of start of study therapy. - Taking the following sensitive CYP substrate medications that have a narrow therapeutic range are excluded from the study unless the subject can be transferred to other medications at least 5 half-lives prior to the start of study treatment: paclitaxel and docetaxel (CYP2C8), phenytoin (CYP2C9), S-mephenytoin (CYP2C19), thioridazine (CYP2D6), theophylline, and tizanidine (CYP1A2) - Active graft-versus-host-disease (GVHD) status post stem cell transplant - Severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications - Concurrent active malignancy under treatment - Administration or consumption of any of the following within 3 days prior to first dose of study drug: grapefruit or grapefruits products, Seville oranges (including marmalade containing Seville oranges) and start fruit - Heart-rate corrected QT (QTc) interval =480 msec (Fridericia's formula) except for underlying right-bundle branch block (RBBB). - Positive for HIV - Subject has an unacceptable white blood cell count - Positive urine pregnancy test, - Participants who not willing to maintain adequate contraception |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta Hospital | Edmonton | Alberta |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | AbbVie, Celgene |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate (ORR) | 3 years | ||
Primary | Dose Limiting Toxicity | 28 days | ||
Primary | Maximum tolerated dose or Recommended Phase 2 Dose | Dose indicated by the mTPI decision | 3 years | |
Primary | Duration of Response | The time from the date of first response until progression, relapse, death, or last follow-up. | 3 years | |
Secondary | Overall Survival | The first day of treatment until death or last contact. | 3 years | |
Secondary | 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. | 3 years |
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