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CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome | Clinical Trials | Clareo Health

WITHDRAWNPHASE1/PHASE2

CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome

A Phase I/II Study of CPI-613 and Hydroxychloroquine for Patients With High Risk MDS Who Have Failed Hypomethylating Therapy

NCT03929211•Wake Forest University Health Sciences

View on ClinicalTrials.gov

Summary

This is a phase 1/2 study of the combination of CPI-613 and hydroxychloroquine for the treatment of high risk myelodysplastic syndrome patients who have failed a hypomethylating agent.

Detailed Description

Primary Objective(s): * To determine the Maximum Tolerated Dose (MTD) of the combination of CPI-613 and Hydroxychloroquine therapy for patients with high risk MDS who have failed hypomethylating therapy. * To determine the overall response rate (complete remission (CR), marrow CR, partial remission (PR), Hematologic improvement (HI)) of high risk MDS patients who have failed hypomethylating agents, treated with the combination of CPI-613 and the maximally tolerated dose of hydroxychloroquine Secondary Objective(s): * To assess the safety of the combination * To assess progression-free-survival (PFS) * To assess the overall survival of MDS patients who have failed hypomethylating agents treated with the combination of CPI-613 and hydroxychloroquine defined as the time from enrolment on study to death from any cause. * To assess any changes in the frequency of blood transfusions OUTLINE: This is a phase I, dose-escalation study of hydroxychloroquine, followed by a phase II study. Patients receive hydroxychloroquine orally (PO) and 6,8-bis(benzylthio)octanoic acid intravenously (IV) over 2 hours on days 1-5. Treatments repeat every 14 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 3, patients receive hydroxychloroquine PO and 6,8-bis(benzylthio)octanoic acid IV over 2 hours on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically documented high risk MDS whose disease has failed to respond, progressed or relapsed while on a hypomethylating agent.
•IPSS-R score of Intermediate, high or very high at time of enrollment
•ECOG Performance Status of ≤3.
•Men and women 18 years of age or older.
•Expected survival \>2 months.
•Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must use accepted contraceptive methods (abstinence, intrauterine device \[IUD\], oral contraceptive or double barrier device) during the study, and must have a negative serum or urine pregnancy test within 1 week prior to treatment initiation.
•Fertile men must practice effective contraceptive methods during the study, unless documentation of infertility exists.
•Patients must have fully recovered from the acute, non-hematological, non-infectious toxicities of any prior treatment with cytotoxic drugs, radiotherapy or other anti-cancer modalities. Patients with persisting, non-hematologic, non-infectious toxicities from prior treatment ≤ Grade 2 are eligible, but must be documented as such.
•Laboratory values obtained ≤2 weeks prior to enrollment must demonstrate adequate hepatic function, renal function, and coagulation as defined below:
•Aspartate aminotransferase \[AST/SGOT\] ≤3x upper normal limit \[UNL\]
+6 more criteria

Exclusion Criteria

•Patients with the following characteristics are excluded:
•Serious medical illness, such as significant cardiac disease (e.g. symptomatic congestive heart failure, unstable angina pectoris, symptomatic coronary artery disease, myocardial infarction within the past 3 months, uncontrolled cardiac arrhythmia, pericardial disease or New York Heart Association Class III or IV), or severe debilitating pulmonary disease, that would potentially increase patients' risk for toxicity.
•Patients with active central nervous system (CNS) or epidural tumor.
•Any active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
•Any condition or abnormality which may, in the opinion of the investigator, compromise his or her safety.
•Pregnant women, or women of child-bearing potential not using reliable means of contraception.
•Fertile men unwilling to practice contraceptive methods during the study period.
•Lactating females.
•Life expectancy less than 2 months.
•Unwilling or unable to follow protocol requirements.
+5 more criteria

Locations (2)

Roswell Park Cancer Institute

Buffalo, New York, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Key Dates

Start Date

May 1, 2021

Primary Completion Date

September 1, 2022

Completion Date

July 1, 2027

Last Updated

April 14, 2021

Conditions

Myelodysplastic SyndromesProgressive Disease

Interventions

CPI-613

DRUG

Hydroxychloroquine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 14, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CPI-613 and Hydroxychloroquine for Patients With High Risk Myelodysplastic Syndrome

Inclusion Criteria

Exclusion Criteria

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