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Antimetabolite
Ivosidenib + Chemotherapy for Acute Myeloid Leukemia
Phase 1
Recruiting
Led By Shira N Dinner, M.D.
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have relapsed/refractory primary (ie, de novo) or secondary (progression of myelodysplastic syndrome [MDS] or myeloproliferative neoplasms [MPN], or therapy-related) acute myeloid leukemia (AML) according to the World Health Organization (WHO) classification with >= 5% leukemic blasts in the bone marrow
Serum creatinine or creatinine clearance < 2 x ULN or >= 30 mL/min based on the Modification of Diet in Renal Disease (MDRD) glomerular filtration rate (GFR) (within 28 days prior to registration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights
Study Summary
This trial is studying the side effects and best dose of ivosidenib when given with combination chemotherapy to treat patients with 1DH1 mutant acute myeloid leukemia that has come back or does not respond to treatment.
Who is the study for?
This trial is for adults with acute myeloid leukemia (AML) that has returned or isn't responding to treatment. They must have an IDH1 mutation, functioning kidneys and liver, no severe heart issues, and not be pregnant or nursing. Participants need to agree to use effective contraception during the study and for 4 months after.Check my eligibility
What is being tested?
The trial tests ivosidenib combined with chemotherapy drugs cytarabine, filgrastim, and fludarabine in patients with AML. It aims to find the safest dose of ivosidenib when used with these chemotherapies and see if this combination is more effective than chemotherapy alone.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, nausea, diarrhea, blood count changes leading to increased infection risk or bleeding problems. Liver function may also be affected.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My AML has returned or didn't respond to treatment, with more than 5% cancer cells in my bone marrow.
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My kidney function, measured by creatinine or its clearance, is within the required range.
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My cancer has an IDH1 R132 mutation.
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I am able to care for myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of dose-limiting toxicity (DLT)
Secondary outcome measures
Incidence of adverse events
Number of patients that receive hematopoietic stem cell transplant after induction treatment
Overall survival
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy, ivosidenib)Experimental Treatment5 Interventions
INDUCTION: Patients receive filgrastim SC QD on days 0-6, fludarabine phosphate IV QD over 30 minutes on days 1-5, cytarabine IV QD over 4 hours on days 1-5, and ivosidenib PO QD on days 7-28. Treatment continues for 28 days in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients receive filgrastim SC QD on days 0-5, fludarabine phosphate IV QD over 30 minutes on days 1-4, cytarabine IV QD over 4 hours on days 1-4, and ivosidenib PO QD on days 1-28. Treatment continues for 28 days for 1 cycle in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cytarabine
FDA approved
Filgrastim
FDA approved
Fludarabine
FDA approved
Fludarabine
FDA approved
Ivosidenib
FDA approved
Find a Location
Who is running the clinical trial?
Agios PharmaceuticalsUNKNOWN
Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
916,938 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,926,048 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an ongoing serious infection that isn't getting better with treatment.My high bilirubin levels are due to a specific condition, not liver issues.I do not have conditions like short-gut syndrome that affect drug absorption.I have had previous treatments for my condition, regardless of how many.I agree to use two effective birth control methods if I can have children.My AML has returned or didn't respond to treatment, with more than 5% cancer cells in my bone marrow.My heart's electrical cycle is within a normal range, not affected by medications.I am not on sensitive medications that can't be stopped before the study starts.I have not had serious heart problems or a stroke in the last month.I do not have acute promyelocytic leukemia.I have never been treated with ivosidenib.I have been treated with IDH inhibitors before.I do not have a severe health issue that would stop me from joining a clinical trial.I have been cancer-free for over a year, except for certain skin, cervical, breast, or early prostate cancers.I am not on strong medications that affect liver enzymes, or I can switch them before the study.I am not pregnant or nursing.My kidney function, measured by creatinine or its clearance, is within the required range.I agree to use a condom during treatment and for 4 months after my last dose of ivosidenib.My cancer has an IDH1 R132 mutation.I am able to care for myself and perform daily activities.My liver tests are within normal limits or high due to leukemia.I am a woman capable of becoming pregnant and have tested negative for pregnancy.I agree to use effective birth control or abstain from sex during and 4 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (combination chemotherapy, ivosidenib)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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