Your session is about to expire
← Back to Search
Other
CTX-712 for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Phase 1 & 2
Recruiting
Led By Guillermo Garcia-Manero, MD
Research Sponsored by Chordia Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured from the date of the last administration of ctx-712 until hsct, or one year from the date of the start of administration of ctx-712.
Awards & highlights
Study Summary
This trial assesses the safety and effectiveness of CTX-712 for AML and HR-MDS. It will determine a recommended dose for further study.
Who is the study for?
Adults (18+) with relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes, who have undergone 1-4 prior treatments. Participants must have adequate organ function and blood counts, agree to contraception if of childbearing potential, and not be suffering from severe lung disease or recent major surgery.Check my eligibility
What is being tested?
The trial is testing CTX-712's safety and effectiveness in two phases. Phase 1 determines the best dose through a '3+3' method where small groups receive increasing doses. Phase 2 evaluates its therapeutic activity at this established dose in patients with specific types of leukemia.See study design
What are the potential side effects?
While specific side effects for CTX-712 are not listed, common ones for cancer drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues indicated by altered blood tests, and potential allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured from the date of the last administration of ctx-712 until hsct, or one year from the date of the start of administration of ctx-712.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured from the date of the last administration of ctx-712 until hsct, or one year from the date of the start of administration of ctx-712.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) related to CTX-712.
Phase 1: The maximum tolerated dose MTD.
Phase 2: Complete remission rate, defined as the proportion of patients who achieve complete remission.
Secondary outcome measures
Phase 1 and 2: Duration of response.
Phase 1 and 2: Objective response rate, defined as the proportion of patients achieving a response.
Phase 1 and 2: Overall survival.
+9 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Phase 2Experimental Treatment1 Intervention
CTX-712 administered at the recommended dose by the expansion cohort
Group II: Dose Expansion CohortExperimental Treatment1 Intervention
Drug: CTX-712 administered at a dose to be determined from the data of dose escalation cohort
Group III: Dose Escalation CohortExperimental Treatment1 Intervention
Drug: CTX-712 administered at 20 mg, 40 mg, 80 mg, 100 mg, 140 mg weekly
Find a Location
Who is running the clinical trial?
Chordia Therapeutics, Inc.Lead Sponsor
TheradexIndustry Sponsor
33 Previous Clinical Trials
1,422 Total Patients Enrolled
Guillermo Garcia-Manero, MDPrincipal InvestigatorM.D. Anderson Cancer Center
20 Previous Clinical Trials
1,345 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last six months.I have heart rhythm problems not managed by medicine.I have not had major surgery in the last 4 weeks.My heart's pumping ability is significantly reduced.I have been diagnosed with acute promyelocytic leukemia.My cancer has returned outside the bone marrow.I have a serious lung condition that requires me to use home oxygen.I agree to use effective contraception or practice abstinence during and for four months after the study.My kidney, liver, and blood tests are within normal ranges.I have active leukemia in my brain or spinal cord.I have had cancer before.I am not pregnant, can take a test to prove it, and will use effective birth control during and up to 4 months after the study.I had a stem cell transplant less than 6 months ago or have graft-versus-host disease grade 1 or higher.I do not have any active, uncontrolled infections and my viral load is negative.I have been diagnosed with AML, HR-MDS, or high marrow blast MDS/MPN.I have had 1 to 4 treatments for my condition before.I can take care of myself but might not be able to do heavy physical work.I have a family history of long QT syndrome.I am 18 years old or older.I have had CAR T-cell therapy or similar treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 2
- Group 2: Dose Escalation Cohort
- Group 3: Dose Expansion Cohort
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.
Are there presently any opportunities for individuals to take part in this inquiry?
"Per the information found on clinicaltrials.gov, this trial has now closed its doors to patient recruitment. Although it was initially declared open for enrollment on April 1st 2023 and last updated February 15th2023, there are 2819 other studies actively recruiting participants at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger