NCT05263284 8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT05263284 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | City of Hope Medical Center |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-12-15 |
| Primary Completion | 2029-01-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2022-12-15 with a primary completion date of 2029-01-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.
Eligibility Criteria
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Age: \>= 18 years. * Eastern Cooperative Oncology Group (ECOG) =\< 2. * Life expectancy \> 3 months. * Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) criteria, with relapsed/refractory disease. * Patients must have any one of the following treatment history criteria: * Relapsed AML * Failed at least 1 line of salvage therapy or * Untreated relapse and are not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT) * De novo AML * have not achieved complete response (CR) after 2 lines of therapy or * refractory to frontline therapy and not eligible for alloHCT * AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy * Patients who have relapsed after allo-HCT are eligible if they are at least 3 months after HCT, do not have active graft versus host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg/day or less). * Male subjects must agree to not donate sperm while taking protocol therapy through at least 90 days after the last dose. * White blood cell (WBC) =\< 25 x 10\^9/L prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and/or during cycle 1 may be required. * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease). * Aspartate aminotransferase (AST) =\< 2.5 x ULN. * Alanine aminotransferase (ALT) =\< 2.5 x ULN. * Creatinine clearance of \>= 50 mL/min per 24 hour urine test or the Cockcroft-Gault formula. * QTc =\< 480 ms. * Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Agreement by females and males of childbearing potential\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months (females) and 3 months (males) after the last dose of protocol therapy. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only). Exclusion Criteria: * Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment period, or within 2 weeks prior to day 1 of protocol therapy, with the following exception: * Hydroxyurea which may be continued through cycle 1. * Expected to undergo HCT within 120 days of enrollment. * Current or planned use of agents that prolong or suspected to prolong QTc. * Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy. * Received strong or moderate CYP3A inhibitors, or consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to day 1 of protocol therapy. * P-glycoprotein (P-gp) inhibitors within 7 days prior to day 1 of protocol therapy. * Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy. * Acute promyelocytic leukemia. * Active central nervous system (CNS) leukemia. * Active fungal infection or bacterial sepsis. * Class III/IV cardiovascular disability according to the New York Heart Association classification. * Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment. Subjects with controlled, asymptomatic atrial fibrillation can enroll. * History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment. * History of unexplained syncope, significant histories of CAD (requiring revascularization by percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]), cardiomyopathy (ejection fraction \[EF\] \< 50%). * Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy). * Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption). * Active peptic ulcer disease. * Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ. * Females only: Pregnant or breastfeeding. * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures. * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics).
Contact & Investigator
Vinod Pullarkat
PRINCIPAL INVESTIGATOR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT05263284 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05263284 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05263284 currently recruiting?
Yes, NCT05263284 is actively recruiting participants. Visit ClinicalTrials.gov or contact City of Hope Medical Center to inquire about joining.
Where is the NCT05263284 trial being conducted?
This trial is being conducted at Duarte, United States.
Who is sponsoring the NCT05263284 clinical trial?
NCT05263284 is sponsored by City of Hope Medical Center. The principal investigator is Vinod Pullarkat at City of Hope Medical Center. The trial plans to enroll 30 participants.
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