Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382168
Status:
RECRUITING
Last Update Posted:
2024-04-24
First Post:
2024-04-19
Brief Title:
DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
Delta-Fly Pharma Inc
Organization:
Delta-Fly Pharma Inc
Study Overview
Official Title:
Phase III Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase III trial evaluates the safety and preliminary efficacy of DFP-10917 combined with venetoclax in relapsed or refractory acute myeloid leukemia DFP-10917 is given as a 14-day continuous IV infusion every 28 days alongside a 14-day oral course of venetoclax following an initial dose ramp-up The initial phase tests a starting dose of 4 mgm²day of DFP-10917 with 400 mg daily of venetoclax The Data Monitoring Committee reviews toxicity after one treatment cycle If DLTs are minimal more patients are added to confirm safety If the lower dose level shows tolerability it proceeds to the Phase II expansion to assess the treatments effectiveness against leukemia using a Simons two-stage design targeting up to 17 participants
Detailed Description:
This study is a Phase III open-label trial exploring dosage and expansion cohorts to assess the safety and preliminary efficacy of DFP-10917 in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia AML DFP-10917 will be administered as a 14-day continuous intravenous infusion starting on Day 1 followed by a 14-day rest period during each 28-day cycle This will occur concurrently with venetoclax administered orally at a dose of 400 mg daily for 14 days following a dose ramp-up phase 100 mg and 200 mg on Day 1 and 2 respectively
In Phase I the starting dose for DFP-10917 is 4 mgm²day administered concurrently with 400 mg of venetoclax once daily for 14 days Dose Level 1 The Data Monitoring Committee DMC will assess dose-limiting toxicities DLTs after three patients are enrolled at this dose level and the last patient has completed the 4-week safety assessment period ie one cycle of the combination regimen At Dose Level 1 4 mgm²day of DFP-10917 with venetoclax 400 mg daily for 14 days if none of the three patients experience a DLT the study will enroll an additional three patients at this dose level to confirm the combinations safety and tolerability If one out of three patients experiences a DLT up to three additional patients may be enrolled If one or fewer out of six treated patients experience a DLT at Dose Level 1 this dose will be declared the recommended Phase II dose RP2D and used in the Phase II expansion cohort If two or more patients out of the total three to six patients at Dose Level 1 experience a DLT the study will continue enrollment at Dose Level 1 4 mgm²day of DFP-10917 for 14 days concurrently with venetoclax 400 mg daily for 10 days of each 28-day cycle to determine the safety and tolerability of Dose Level -1 A patient who discontinues therapy during Cycle 1 without experiencing DLTs is considered evaluable for safety purposes only if all scheduled doses of DFP-10917 and at least 80 of the venetoclax doses were administered in the first cycle Once the RP2D of DFP-10917 in combination with venetoclax is determined the expansion cohort will begin enrollment to evaluate the anti-leukemia efficacy of this combination A Simons two-stage min-max design will be employed with up to 17 patients expected to participate
In Phase I the starting dose for DFP-10917 is 4 mgm²day administered concurrently with 400 mg of venetoclax once daily for 14 days Dose Level 1 The Data Monitoring Committee DMC will assess dose-limiting toxicities DLTs after three patients are enrolled at this dose level and the last patient has completed the 4-week safety assessment period ie one cycle of the combination regimen At Dose Level 1 4 mgm²day of DFP-10917 with venetoclax 400 mg daily for 14 days if none of the three patients experience a DLT the study will enroll an additional three patients at this dose level to confirm the combinations safety and tolerability If one out of three patients experiences a DLT up to three additional patients may be enrolled If one or fewer out of six treated patients experience a DLT at Dose Level 1 this dose will be declared the recommended Phase II dose RP2D and used in the Phase II expansion cohort If two or more patients out of the total three to six patients at Dose Level 1 experience a DLT the study will continue enrollment at Dose Level 1 4 mgm²day of DFP-10917 for 14 days concurrently with venetoclax 400 mg daily for 10 days of each 28-day cycle to determine the safety and tolerability of Dose Level -1 A patient who discontinues therapy during Cycle 1 without experiencing DLTs is considered evaluable for safety purposes only if all scheduled doses of DFP-10917 and at least 80 of the venetoclax doses were administered in the first cycle Once the RP2D of DFP-10917 in combination with venetoclax is determined the expansion cohort will begin enrollment to evaluate the anti-leukemia efficacy of this combination A Simons two-stage min-max design will be employed with up to 17 patients expected to participate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None