BridgeMD
New treatment option for Acute Myeloid Leukemia
Official title Cladribine Venetoclax in Monocytic AML
ClinicalTrials.gov ID: NCT06232655
What this study is testing
What is Cladribine?
Cladribine 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 Mavenclad, Leustatin.
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
- Investigation of Relapsed or refractory AML with a monocytic phenotype after failure of hypomethylating agent+venetoclax
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- A subject will be eligible for study participation if they meet the following criteria within 28 days prior to the first day of treatment. Historical...
- Subject must have confirmation of non-acute promyelocytic leukemia (APL) Acute Myeloid Leukemia (AML) with a monocytic or monoblastic phenotype or a...
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation...
You likely can't join if
- Subject has received prior treatment with cladribine for AML.
- Subject has a white blood cell count \> 25 x 109/L. Note: hydroxyurea and/or leukapheresis are permitted to meet this criterion.
- Subject has known active central nervous system (CNS) involvement of AML.
- Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal). Uncontrolled is defined as ongoing...
- Subject has any clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this...
- New York Heart Association heart failure \> class 2
See the full eligibility criteria
- A subject will be eligible for study participation if they meet the following criteria within 28 days prior to the first day of treatment. Historical records are permitted per investigator discretion.
- Subject must have confirmation of non-acute promyelocytic leukemia (APL) Acute Myeloid Leukemia (AML) with a monocytic or monoblastic phenotype or a Ras pathway mutation. The subject's AML must be relapsed after or...
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- Adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation (2021).
- Adequate liver function, as demonstrated by:
- Aspartate aminotransferase (AST) ≤ 3.0 x ULN\
- Alanine aminotransferase (ALT) ≤ 3.0 x ULN\
- Total bilirubin ≤ 1.5 x ULN, unless considered to be due to leukemic organ involvement or Gilbert's syndrome\ \ In people with Gilbert's syndrome, bilirubin needs to be ≤ 4 x ULN
- Non-sterile male people must use contraceptive methods with partner(s) at least prior to beginning study drug administration and continuing up to 90 days after the last dose of study drug. Male people must agree to...
- Female people must be either:
- Postmenopausal: defined as age \> 60 years with no menses for 12 or more months without an alternative medical cause; OR
- Permanently surgically sterile (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy); OR
- If subject is of childbearing potential, use of contraception is required while on study treatment and for 6 months after the last dose.
- Subject must voluntarily sign an informed consent, approved by the Institutional Research Board (IRB), prior to the initiation of any research-related screening or study procedures.
- Subject has received prior treatment with cladribine for AML.
- Subject has a white blood cell count \> 25 x 109/L. Note: hydroxyurea and/or leukapheresis are permitted to meet this criterion.
- Subject has known active central nervous system (CNS) involvement of AML.
- Subject exhibits evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal). Uncontrolled is defined as ongoing signs/symptoms related to the infection without improvement despite...
- Subject has any clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study, including but not limited to:
- New York Heart Association heart failure \> class 2
- Renal, neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
- Subject has a QTc interval \> 470 msec.
- Subject has a history of other malignancies within 2 years prior to study entry, with the following exceptions:
- Adequately treated in situ carcinoma of the breast or cervix
- Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
- Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent
- Prostate cancer not requiring therapy beyond hormonal therapy
- Subject is pregnant or breastfeeding.
- Subject is known to be positive for HIV. HIV testing is not required.
- Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load. Hepatitis B or C testing is not required, and people with serologic evidence of prior...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, 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.