← Back to Search

Anti-metabolite

Navtemadlin + Chemotherapy for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Kevin R Kelly
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be considered candidates for intensive chemotherapy treatment with standard doses of cytarabine and idarubicin ("7+3 regimen").
All non-hematological adverse events of any prior chemotherapy, surgery, or radiotherapy, except alopecia, must have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade =< 2 prior to starting therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing navtemadlin in combination with standard chemotherapy drugs to treat acute myeloid leukemia. Navtemadlin works by blocking a protein called MDM2 that is needed for cell growth. Chemotherapy drugs work in different ways to stop the growth of cancer cells. Giving navtemadlin with chemotherapy drugs may stabilize cancer for longer.

Who is the study for?
This trial is for adults with newly diagnosed, untreated Acute Myeloid Leukemia (AML) that's not acute promyelocytic leukemia. They must have a specific protein (wild-type p53), be fit for intensive chemo, and have good heart function and organ health. People with HIV can join if their treatment is effective. Pregnant or breastfeeding women can't join, nor those unwilling to use contraception.Check my eligibility
What is being tested?
The trial tests Navtemadlin combined with standard chemotherapy drugs Cytarabine and Idarubicin in AML patients. It aims to find the best dose of Navtemadlin and see how well it works alongside these chemotherapies by blocking a growth-essential protein in cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system, blood disorders from chemotherapy agents like Cytarabine and Idarubicin, as well as potential risks associated with new drug Navtemadlin which may affect cell growth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for intensive chemotherapy with cytarabine and idarubicin.
Select...
All my side effects from previous treatments, except hair loss, are mild now.
Select...
My kidney function tests are within normal limits.
Select...
My heart pumps well, with an ejection fraction of 50% or higher.
Select...
I have AML, not treated before, except for certain treatments if I had MDS before it became AML.
Select...
My cancer has a normal p53 gene according to DNA tests.
Select...
I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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
Incidence of adverse events
Secondary outcome measures
Pharmacokinetic (PK) profile of navtemadlin in combination with cytarabine and idarubicin
Other outcome measures
Complete cytogenetic response to navtemadlin, cytarabine and idarubicin
Complete response rate to navtemadlin, cytarabine and idarubicin
Pharmacodynamic (PD) effects of navtemadlin, in combination with induction chemotherapy on leukemia blasts
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (navtemadlin, cytarabine, idarubicin)Experimental Treatment3 Interventions
Patients receive navtemadlin PO QD on days 1-7, cytarabine IV BID over 3 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with residual disease may receive cytarabine IV BID over 3 hours for 5 days and idarubicin IV over 10-15 minutes for 2 days starting between days 14-21 of cycle 1 or the second cycle of navtemadlin, cytarabine, and idarubicin. Patients who achieve a CR or a CRi in either cycle 1 or 2 may receive cytarabine IV BID over 3 hours on days 1, 3, and 5 for 3-4 additional 28 to 35-day cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
2016
Completed Phase 3
~3310
Idarubicin Hydrochloride
2013
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,660 Previous Clinical Trials
40,924,248 Total Patients Enrolled
Kevin R KellyPrincipal InvestigatorCity of Hope Comprehensive Cancer Center LAO
1 Previous Clinical Trials
58 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 the FDA sanctioned Navtemadlin for general use?

"Due to the paucity of clinical evidence, Navtemadlin was assigned a score of 1 for safety. This drug is currently undergoing Phase 1 trials and has yet to receive approval in terms of efficacy or safety."

Answered by AI

How many participants are included in the maximum capacity of this experiment?

"Indeed. According to the information located on clinicaltrials.gov, this experiment is currently in need of volunteers and has been since July 29th 2020. 24 participants are sought after from 5 different sites with an update taking place most recently on November 24th 2022."

Answered by AI

Are there any vacancies in this research program for participants?

"Clinicaltrials.gov reports that this research project is actively recruiting participants, with the trial being published on July 29th 2020 and last revised on November 24th 2022."

Answered by AI

What types of conditions is Navtemadlin typically employed in the treatment of?

"Navtemadlin has been used to treat leptomeningeal metastases, acute promyelocytic leukemia, and meningeal leukemia."

Answered by AI

Are there any precedents for using Navtemadlin in a clinical setting?

"At present, there are 249 clinical trials investigating Navtemadlin with 61 studies in Phase 3. Providence Rhode island is the epicentre of this research; however, 10368 sites across the world have opened their doors to participating in these trials."

Answered by AI

In what geographical areas are these experiments being conducted?

"This clinical trial is running in several sites, including USC / Norris Comprehensive Cancer Center (Los Angeles), Laura and Isaac Perlmutter Cancer Center at NYU Langone (New york City), Los Angeles County-USC Medical Center (Oklahoma City) as well as 5 additional medical centres."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia
2021. "Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04190550.
~1 spots leftby Jun 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top