Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05564650 | Navitoclax in Relapsed or Refractory High-Risk Myelodysplastic Syndrome | PHASE1 | COMPLETED | 6 | — | — | Jan 12, 2023 | May 8, 2026 | May 19, 2026 | 1 | United States |
The Bayesian optimal interval (BOIN) design will be employed to find the MTD. The BOIN design is implemented in a simple way. It is more flexible and possesses superior operating characteristics that are comparable to those of the more complex model based designs.
A 90% confidence interval will be computed for the CR rate by cycle 4.
| Arm | Type | Description |
|---|---|---|
| Treatment (navitoclax, decitabine, venetoclax) | EXPERIMENTAL | This is a single-center trial of navitoclax, venetoclax and decitabine in adult patients with R/R HR-MDS who have previously failed HMA therapy. This trial was intended to be a Phase 1/2 trial but the trial never moved forward to Phase 2. In the phase I dose escalation portion, patients will receive navitoclax in combination with standard dosing of venetoclax and decitabine. The maximally tolerated dose (MTD) will be the recommended phase II dose (RP2D). Previously, navitoclax in combination with venetoclax and chemotherapy in ALL found the MTD to 50mg of nativoclax po. In the phase II dose expansion portion, patients will receive navitoclax at the RP2D in combination with standard dose venetoclax and decitabine. Patients will continue on treatment with navitoclax, venetoclax and decitabine until relapse, dose-limiting toxicity, availability of alternate therapy or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| Navitoclax | BIOLOGICAL | Given PO |
| Venetoclax | DRUG | Given PO |
| Decitabine | DRUG | Given IV |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy |
| Biospecimen Collection | PROCEDURE | Undergo collection of blood |
| Laboratory Biomarker Analysis | OTHER | Correlative studies |
| Quality-of-Life Assessment | OTHER | Ancillary studies |
Inclusion Criteria: * Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female, aged 18 years or older * Must have myelodysplastic syndrome with Revised International Prognostic Score (IPSS-R) of at ...