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DNA Methyltransferase Inhibitor

DFP-10917 for Acute Myeloid Leukemia

Phase 3

Recruiting

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

Study 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Complete remission (CR) rate

Duration of complete remission

Secondary outcome measures

Adverse events

Duration overall response

Overall response rate (ORR)

+5 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Delta-Fly Pharma, Inc.Lead Sponsor

3 Previous Clinical Trials

122 Total Patients Enrolled

Tapan Kadia, MDPrincipal InvestigatorM.D. Anderson Cancer Center

5 Previous Clinical Trials

207 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has DFP-10917 been explored in other research?

"As of right now, 1241 clinical trials involving DFP-10917 are ongoing with 206 in Phase 3. Although a few research facilities for DFP-10917 are based in Leipzig, Sachsen, there are 34606 different locations worldwide where studies for DFP-10917 are taking place."

Answered by AI

Is this clinical trial taking place in multiple locations within the city?

"This clinical trial is being conducted at UF-Health Cancer Center Gainesville (Florida), New york Medical College (New York), University of Vermont Medical Center (Vermont), and 37 other hospitals."

Answered by AI

Are there any patients required for this clinical trial at the moment?

"That is accurate. The listing on clinicaltrials.gov says that the research team is actively looking for participants. This trial was first posted on November 22nd, 2019 and has been updated as recently as October 18th, 2020. There are 37 different enrolling sites and the goal is to have 450 patients total."

Answered by AI

How many individuals are being given the opportunity to participate in this clinical trial?

"In order to carry out this clinical trial, we require 450 individuals that fit the pre-stated inclusion criteria. These potential participants can be located at different hospitals including UF-Health Cancer Center Gainesville in Gainesville, Florida and New york Medical College in Valhalla, New York."

Answered by AI

Is DFP-10917 known to cause any negative health effects in humans?

"DFP-10917 is considered safe according to our 3-point scale at Power. This is due to the fact that it has reached Phase 3 trials, which signifies that there is evidence of its efficacy and safety from multiple rounds of testing."

Answered by AI

What are the primary purposes for which DFP-10917 is prescribed?

"DFP-10917 is often used to help patients with multiple sclerosis, but it can also serve as a tool for diagnosing other conditions like merkel cell cancer. Additionally, DFP-10917 helps doctors get clear images and accurate blood counts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage

2019. "Trial of DFP-10917 vs Non-Intensive or Intensive Reinduction for AML Patients in 2nd/3rd/4th Salvage". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03926624.