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DNA Methyltransferase Inhibitor
Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage
Phase 3
Waitlist Available
Led By Tapan Kadia, MD
Research Sponsored by Delta-Fly Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing an experimental treatment called DFP-10917 against standard treatments for relapsed or refractory acute myeloid leukemia (AML). Patients in the experimental arm will receive DFP-10917 by continuous intravenous infusion for 14 days, followed by a 14-day resting period, for up to 6 cycles. Patients in the control arm will receive standard treatments, which may include non-intensive reinduction or intensive reinduction, depending on the patient's prior induction treatment.
Eligible Conditions
- Acute Myeloid Leukemia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete remission (CR) rate
Duration of complete remission
Secondary study objectives
Adverse events
Duration overall response
Overall response rate (ORR)
+5 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment1 Intervention
DFP-10917 Dose: 6 mg/m²/day administered by continuous infusion for 14 days followed by a 14-day resting period per 28-day treatment cycle. If a patient experiences a significant treatment-related AE, the patient may undergo one dose reduction of DFP-10917 to 4 mg/m²/day x 14 days for subsequent treatment cycles
Group II: ControlActive Control9 Interventions
Non-Intensive:
* LoDAC: 20 mg SC BID 10 days
* Azacitidine: 75 mg/m²/day SC 7 days(or 5+2)
* Decitabine: CIV 20 mg/m²x5 days
* Venetoclax + LoDAC/Azacitidine/Decitabine:LoDAC-Venetoclax ramp-up to 600 mgxday. Cytarabine SC 20 mg/m²xday D1-10. Azacitidine or Decitabine-Venetoclax ramp-up to 400 mgxday. Azacitidine IV or SC 75 mg/m² D1-7. Decitabine IV 20 mg/m² on D1-5 or 1-10.
Intensive:
* High DAC: cytarabine 1-2 g/m² up to 5 days, max total dose 10 g/m²
* FLAG: D1-5: fludarabine 30 mg/m² IV for 30min, D1-5: cytarabine 1-2 g/m² for 4hr daily x 5 \& G-CSF 5 mcg/kg or 300 mcg/m² until PMN recovery, with or without idarubicin D1-3 8 mg/m² IV dailyx3 (FLAG-Ida)
* MEC: D1-6: mitoxantrone 6 mg/m² IV bolus, etoposide 80 mg/m² IV 1hr \& cytarabine 1g/m² IV 6hr.
* CLAG/M or Ida = cladribine 5 mg/m² D1-5, cytarabine 2 g/m² D1-5, G-CSF 300 μg D0-5, mitoxantrone 10 mg/m² D1-3 or Idarubicin 10 mg/m² D1-3.
* Intermediate DAC: cytarabine 20 mg/m² IV dailyx5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DFP-10917
2012
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Delta-Fly Pharma, Inc.Lead Sponsor
4 Previous Clinical Trials
161 Total Patients Enrolled
Tapan Kadia, MDPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
207 Total Patients Enrolled