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New treatment option for Acute Myeloid Leukemia
Official title 8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT05263284
What this study is testing
What is 8-Chloroadenosine?
8-Chloroadenosine is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as 8-Chloro-adenosine, 8-Cl-adenosine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment...
- 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...
See the full eligibility 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...
- Male people 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...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only).
- 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...
- 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. people 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] \<...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.