Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Mye… (NCT04926285) | Clinical Trial Compass
CompletedPhase 1
Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)
United States6 participantsStarted 2022-06-21
Plain-language summary
This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an induction phase, followed by a consolidation phase if applicable.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age 18-75 years of age at time of consent.
✓. Have relapsed/refractory AML (primary or secondary) and have progressed on ≥ 1 line of therapy, at least one of which must have included a VEN-containing regimen.
✓. Eastern Cooperative Oncology Group (ECOG) Performance score 0-2
✓. Prior cancer treatment must be completed at least 21 days prior to registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or baseline.
✓. Life expectancy of 6 months or greater as determined by the treating physician.
✓. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 28 days prior to registration.
✓. Provided written informed consent and HIPAA authorization for release of personal health information, approved by an Institutional Review Board (IRB).
✓. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Exclusion criteria
✕. Patients with history of prior use of Omacetaxine.
✕. White blood cell count \> 25 × 109/L (hydroxyurea permitted to decrease WBC count).
✕. History of other malignancies within 1 year prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
What they're measuring
1
To establish the maximum tolerated dose (MTD) of Omacetaxine in combination with Venetoclax
✕. Investigational drug use within 4 weeks of study entry.
✕. History of CHF requiring treatment, left ventricular ejection fraction ≤ 40%, cardiac insufficiency grade III or IV per New York Heart Association classification (NYHA; see Appendix 2), or chronic stable angina