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Protein Degrader

AB8939 for Acute Myeloid Leukemia

Phase 1 & 2

Recruiting

Led By Norbert Vey, MD

Research Sponsored by AB Science

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with documented diagnosis of acute myeloid leukemia (AML) based on the last version of the World Health Organization classification and eligible to second or third line of treatment

ECOG performance status ≤ 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 56 days

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerated by people with leukemia. They will be looking for any side effects and the highest dose that does not cause too many side effects.

Who is the study for?

This trial is for adults with Acute Myeloid Leukemia or high-risk Myelodysplastic Syndromes who've had previous treatments fail. They must be in good physical condition (ECOG ≤ 1), able to consent, and follow study procedures like bone marrow biopsies. It's not for those eligible for standard care, stem cell transplant, have certain leukemia types or CNS involvement, recent transplants, or are pregnant/breastfeeding.Check my eligibility

What is being tested?

The trial tests AB8939's safety and tolerability in patients with AML by finding the highest dose they can take without serious side effects. Participants will also receive Azacitidine as part of the treatment regimen.See study design

What are the potential side effects?

Specific side effects aren't listed but generally include reactions related to drug tolerance levels such as fatigue, nausea, blood count changes, and potential organ-specific toxicity which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

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

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I have acute myeloid leukemia and need second or third line treatment.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have a high-risk myelodysplastic syndrome not responding to first treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 56 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 56 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 56 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of dose limiting toxicity (DLT)

Secondary outcome measures

Objective Response Rate

Side effects data

From 2023 Phase 1 trial • 48 Patients • NCT02038777

67%

Pyrexia

67%

Pneumonia

33%

Enteritis infectious

33%

Hyperaesthesia teeth

33%

Nausea

33%

Infective tenosynovitis

33%

Bronchitis

33%

Bacteraemia

33%

Rhinitis

33%

Blood creatine phosphokinase increased

33%

Prothrombin time prolonged

33%

Dysgeusia

33%

Muscle spasms

33%

Auricular chondritis

33%

Small intestinal haemorrhage

33%

Malaise

33%

Oedema

33%

Influenza

33%

Nasopharyngitis

33%

Phlebitis

100%

80%

60%

40%

20%

Study treatment Arm

Monotherapy Cohort: PF-04449913 25 mg

Monotherapy Cohort: PF-04449913 50 mg

Monotherapy Cohort: PF-04449913 100 mg

Combination Cohort 1 (Unfit Participants): PF-04449913 100 mg + LDAC 20 mg

Combination Cohort 2 (Fit Participants): PF-04449913 100 mg + Cytarabine + Daunorubicin

Combination Cohort 3: PF-04449913 100 mg + Azacitidine

Continuation Cohort (Monotherapy Cohort): PF-04449913 100 mg

Expansion Cohort (Unfit Participants): PF-04449913 100 mg+ LDAC 20 mg

Trial Design

2Treatment groups

Experimental Treatment

Group I: AB8939 plus azacitidineExperimental Treatment2 Interventions

AB8939 administered in combination with azacitidine

Group II: AB8939Experimental Treatment1 Intervention

AB8939 administered as a single agent

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azacitidine

2012

Completed Phase 3

~1440

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AB ScienceLead Sponsor

38 Previous Clinical Trials

15,644 Total Patients Enrolled

Norbert Vey, MDPrincipal InvestigatorInstitut Paoli Calmettes, Marseille, France

7 Previous Clinical Trials

710 Total Patients Enrolled

Nicholas Short, MDPrincipal InvestigatorMD Anderson Cancer Center, Houston, Texas

5 Previous Clinical Trials

286 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment in this trial still available?

"Affirmative. Clinicaltrials.gov data indicates that this medical investigation, which was first introduced on June 1st 2022, is actively recruiting participants. Approximately 78 subjects need to be sourced from one centre of care."

Answered by AI

What is the patient population for this clinical investigation?

"Affirmative. Per the clinicaltrials.gov website, this medical investigation is actively looking for volunteers and was first advertised on June 1st 2022 with a subsequent update on June 23rd of the same year. The study requires 78 participants to be recruited from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

2022. "AB8939 in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05211570.