Study of Enasidenib and Venetoclax in IDH2-Mutated Blood Cancers

  • STATUS
    Recruiting
  • End date
    Jul 6, 2023
  • participants needed
    48
  • sponsor
    University Health Network, Toronto
Updated on 6 December 2021
cancer
lymphoma
myelodysplastic syndromes
induction chemotherapy
refractory acute myeloid leukemia (aml)
venetoclax
enasidenib
IDH2

Summary

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.

Description

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).

Details
Condition acute myeloblastic leukemia, Relapsed Cancer, Recurrent Cancer, Acute myeloid leukemia, Acute Myeloid Leukemia, IDH2 Gene Mutation, anll, Refractory Cancer, Acute Myelogenous Leukemia (AML), Cancer Refractory, Recurrent Carcinoma, acute myelogenous leukemia
Treatment venetoclax, Enasidenib
Clinical Study IdentifierNCT04092179
SponsorUniversity Health Network, Toronto
Last Modified on6 December 2021

Eligibility

Yes No Not Sure

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-nave 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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