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Anti-tumor antibiotic

Dose Level 1 for Acute Myeloid Leukemia

Q: At how many distinct locations is this clinical trial currently being conducted?

<p>Enrollment for this research is ongoing at 5 centers, including Winston-Salem, Dallas, and Burlington among others. It is advisable to choose the facility closest to you to reduce travel obligations in case of participation.</p>

Q: Is the current clinical trial open for patient enrollment at this time?

<p>As per information available on clinicaltrials.gov, the current trial is not actively seeking subjects. The study was initially shared on 5/31/2024 and last revised on 4/19/2024. Although this specific trial is no longer enrolling participants, there are currently 1498 other studies that are open for recruitment.</p>

Phase 1 & 2

Waitlist Available

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

Eastern Cooperative Oncology Group performance status of 0, 1, or 2

Histologically or pathologically confirmed diagnosis of acute myeloid leukemia based on World Health Organization classification that has relapsed after, or is refractory to, up to 2 prior induction regimens that may have included intensive chemotherapy, epigenetic therapy, or targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months.

Awards & highlights

Study Summary

"This trial is testing a new drug, DFP-10917, in combination with venetoclax for patients with relapsed or refractory acute myeloid leukemia. The trial involves giving D

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia that has come back or didn't respond to previous treatments. Participants must be able to handle continuous IV infusions and oral medications, and have acceptable organ function.Check my eligibility

What is being tested?

The study tests DFP-10917 given as a continuous IV infusion over 14 days combined with an oral course of venetoclax in patients. The safety and initial effectiveness are evaluated, starting at specific doses which may increase if safe.See study design

What are the potential side effects?

Possible side effects include reactions related to the IV infusion, gastrointestinal issues from the oral medication, potential impact on blood cell counts leading to increased infection risk, fatigue, and liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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My acute myeloid leukemia has returned or didn't respond after up to 2 treatments.

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My organ functions are within normal ranges according to recent tests.

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I am not pregnant and agree to use birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of the study treatment to death from any cause, whichever occurs first, assessed for up to 100 months. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of patients with dose-limiting toxicities assessed by CTCAE v5.0.

Number of patients with treatment-related adverse events assessed by CTCAE v5.0.

Recommended Phase 2 dose of DFP-10917 in combination with venetoclax (the dose at which <2 out of 6 patients experience a dose-limiting toxicity during the safety assessment period).

Secondary outcome measures

Area under the curve of DFP-10917.

Maximum concentration of DFP-10917.

Overall survival.

+4 more

Other outcome measures

Area under the curve of venetoclax.

Clearance of DFP-10917.

Elimination half-life of venetoclax.

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose Level 1Experimental Treatment2 Interventions

DFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 14 days

Group II: Dose Level -1Experimental Treatment2 Interventions

DFP-10917 4 mg/m^2/day with venetoclax 400 mg once daily for 10 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Venetoclax

2019

Completed Phase 3

~1990

DFP-10917

2012

Completed Phase 2

~70

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Delta-Fly Pharma, Inc.Lead Sponsor

4 Previous Clinical Trials

572 Total Patients Enrolled

Frequently Asked Questions

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

At how many distinct locations is this clinical trial currently being conducted?

"Enrollment for this research is ongoing at 5 centers, including Winston-Salem, Dallas, and Burlington among others. It is advisable to choose the facility closest to you to reduce travel obligations in case of participation."

Answered by AI

Is the current clinical trial open for patient enrollment at this time?

"As per information available on clinicaltrials.gov, the current trial is not actively seeking subjects. The study was initially shared on 5/31/2024 and last revised on 4/19/2024. Although this specific trial is no longer enrolling participants, there are currently 1498 other studies that are open for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia

2024. "Phase I/II Study of DFP-10917 in Combination With Venetoclax in Relapsed or Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382168.

All > Acute Myeloid Leukemia > Aml