Your session is about to expire
← Back to Search
Anti-metabolites
CPX-351 + Ivosidenib for Acute Myeloid Leukemia/Myelodysplastic Syndrome
Phase 2
Recruiting
Led By Courtney DiNardo
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of =< 2
Creatinine clearance >= 30 ml/min based on the Cockcroft-Gault equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying how well CPX-351 and ivosidenib work in treating patients with leukemia or myelodysplastic syndrome that has an IDH1 mutation.
Who is the study for?
This trial is for adults with acute myeloid leukemia or high-risk myelodysplastic syndrome that have an IDH1 mutation. Participants can be new to treatment or have relapsed and must be fit enough for intensive chemotherapy (ECOG <=2). They should not have severe heart issues, a history of certain brain infections, or excessive prior anthracycline exposure. Women must avoid pregnancy and men must refrain from donating sperm during the trial.Check my eligibility
What is being tested?
The study is testing CPX-351 (a chemo drug combo) alongside Ivosidenib in patients with specific genetic changes in their cancer cells. The goal is to see if this combination helps control the growth of cancer cells better than current treatments by blocking enzymes needed for cell growth.See study design
What are the potential side effects?
Possible side effects include typical chemotherapy-related issues like fatigue, nausea, hair loss, increased risk of infection due to low blood counts, as well as potential liver problems indicated by elevated bilirubin levels. Ivosidenib may cause changes in heart rhythm or other organ-specific inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
Select...
My kidneys are functioning well enough to clear waste.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Duration of response
Event-free survival
Incidence of adverse events
+1 moreOther outcome measures
Minimal residual disease (MRD) status
Side effects data
From 2020 Phase 2 trial • 56 Patients • NCT0228672625%
Febrile Neutropenia
21%
Neutropenic Fever
17%
Lung Infection
17%
Sepsis
13%
Insomnia
8%
Infection
8%
Pericardial Effusion
8%
Hypertension
4%
Pancreatitis
4%
Intracranial Hemorrhage
4%
Cardiac Disorders
4%
Pleural Effusion
4%
Fever
4%
Joint Effusion
4%
Alanine aminotransferase Increase
4%
Anxiety
4%
Blood Bilirubin Increase
4%
Acute Coronary Syndrome
4%
Respiratory Failure
4%
Multi-Organ Failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Intermediate-dose (75 Units/m^2) CPX-351)
Arm III (Standard-dose (100 Units/m^2) CPX-351)
Arm I (Lower-dose (50 Units/m^2) CPX-351)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CPX-351, ivosidenib)Experimental Treatment2 Interventions
INDUCTION: Patients receive CPX-351 IV over 90 minutes on days 1, 3, and 5, and ivosidenib PO QD on days 1-28. Patients who do not achieve complete remission may receive a second cycle of induction therapy in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission proceed to consolidation.
CONSOLIDATION: Patients receive CPX-351 IV over 90 minutes on days 1 and 3, and ivosidenib PO QD on days 1-28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive ivosidenib PO QD for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients who are experiencing clinical benefit and who have not experienced excessive toxicity after completion of 2 years of maintenance may be eligible to continue therapy after discussion with the principal investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ivosidenib
2019
Completed Phase 1
~20
Liposome-encapsulated Daunorubicin-Cytarabine
2016
Completed Phase 2
~100
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,972 Previous Clinical Trials
1,787,291 Total Patients Enrolled
Courtney DiNardoPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
679 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I do not have severe stomach or metabolic issues affecting medication absorption.I have previously been treated with ivosidenib or CPX-351.I am not on strong CYP3A4 inducers, or I can switch to another medication before starting the study.I don't have major side effects from previous cancer treatments.I am not on chemotherapy, except for specific allowed treatments.I am not pregnant, using effective birth control, or not of childbearing potential.I have AML or high-risk MDS/MPN and haven't had, or no longer respond to, intensive chemotherapy.I agree not to have unprotected sex or donate sperm for 90 days after my last dose.I have a history of PML.I don't have active graft-versus-host disease after a stem cell transplant.My liver enzymes are within normal limits, or high due to my leukemia.I do not have any severe health issues that could make the study treatment unsafe for me.My cancer has a specific IDH1 mutation.I do not have severe heart failure, unstable chest pain, or a weak heart pump.I haven't had cancer treatment in the last 7 days.I have received a high dose of anthracycline drugs, or a lower dose if I had radiation therapy to the chest area.My kidneys are functioning well enough to clear waste.I have been diagnosed with acute promyelocytic leukemia.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CPX-351, ivosidenib)
Awards:
This trial has 1 awards, including:- 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.
How many participants are engaged in this research endeavor?
"Affirmative. Clinicaltrials.gov provides evidence that this medical experiment, which was made available to the public on December 30th 2020, is searching for participants. Approximately thirty individuals must be sourced from one clinical site."
Answered by AI
Is the enrollment period for this research still active?
"Affirmative. According to the information available on clinicaltrials.gov, this research project is currently enrolling participants - it was initially posted on December 30th 2020 and updated lastly June 15th 2022. The trial requires a total of 30 individuals from one participating medical centre."
Answered by AI
Has the FDA sanctioned Liposome-encapsulated Daunorubicin-Cytarabine for use?
"Based on our assessment, Liposome-encapsulated Daunorubicin-Cytarabine is of moderate safety as it has been tested in a Phase 2 trial. While there is evidence that the drug meets established safety guidelines, clinical efficacy remains unproven."
Answered by AI
How is Liposome-encapsulated Daunorubicin-Cytarabine typically used to treat patients?
"Liposome-encapsulated Daunorubicin-Cytarabine is a commonly used treatment for acute myelocytic leukemia. It has also been utilized to manage blast phase chronic myelocytic leukemia, lymphoma and certain cases of idh1 mutation."
Answered by AI
Have researchers previously explored the potential of Liposome-encapsulated Daunorubicin-Cytarabine?
"Currently, there are 278 studies operating in relation to Liposome-encapsulated Daunorubicin-Cytarabine with 67 of those being Phase 3 trials. While the bulk of these researches take place in New york City, this medication is trialled at 13254 various sites globally."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger