New drug cocktail aims to beat leukemia in patients too frail for standard chemo
NCT ID NCT07172204
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a combination of two drug regimens—VA (venetoclax and azacitidine) and low-dose CHA (cladribine, homoharringtonine, and cytarabine)—given in alternating cycles to newly diagnosed acute myeloid leukemia (AML) patients aged 60 or older who cannot tolerate intensive chemotherapy. The goal is to see if this approach can clear leukemia cells from the bone marrow (MRD negativity) and improve outcomes. The study will enroll 25 participants across multiple centers in China.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Venetoclax, azacitidine, cladribine, homoharringtonine, and cytarabine
- What this could lead to
- If successful, this could offer a more effective treatment option for older or frail AML patients who cannot tolerate standard chemotherapy, potentially leading to better disease control and longer remission.
- What could go wrong
- This is a small, early-phase (phase II) study with only 25 participants, so results may not apply to all patients. The drug combination also carries risks like infection, bleeding, and organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Understand the research and sign a written informed consent form; * Be newly diagnosed with AML according to WHO 2022 criteria without prior treatment; * or unwilling to undergo IC. Ineligibility for IC is defined as meeting any of the following criteria: * Age ≥ 60 years * Age 18-59 years but ineligible for intensive chemotherapy (IC) , meet ≥1 of the following: * Eastern Cooperative Oncology Group (ECOG) performance status ≥2 at screening; * Severe heart failure (congestive heart failure requiring treatment or myocardial infarction history with ejection fraction ≤50%); * Severe pulmonary dysfunction (DLCO ≤65%, FEV1 ≤65%, dyspnea at rest, or oxygen dependence); * Severe renal insufficiency requiring dialysis; * Child-Pugh B or C cirrhosis, or hepatic impairment with total bilirubin \>1.5×ULN; * Mental illness requiring inpatient psychiatric treatment; * Any comorbidity deemed by physician to contraindicate IC. Exclusion Criteria: * Diagnosis of: AML arising from chronic myeloid leukemia (CML); myeloid sarcoma; acute promyelocytic leukemia (APL) or presence of FLT3-ITD mutations; * Active malignancies (except adequately treated carcinoma in situ or basal cell carcinoma) within 2 years prior to Cycle 1 Day 1 (C1D1); * Major surgery or systemic anticancer therapy within 28 days before C1D1; * Known hypersensitivity to: Active pharmaceutical ingredients: cladribine, homoharringtonine, cytarabine, venetoclax, azacitidine; Any excipients in study drug formulations; * GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders; * Uncontrolled active infection; * Controlled infection permitted if: Afebrile (\<38°C) and hemodynamically stable (SBP \>90 mmHg, HR \<100 bpm) for ≥72 hours pre-C1D1; on non-interacting antimicrobial regimen; active HBV/HCV infection (Chronic carriers require PI approval with viral load monitoring); HIV-positive patients receiving HAART; * Pregnancy/lactation or refusal of contraception: Negative serum β-hCG within 24h pre-C1D1; * Psychiatric disorders or social circumstances compromising protocol compliance; * Prior AML-directed therapy except: cytoreduction for hyperleukocytosis per institutional guidelines (hydroxyurea, leukapheresis); supportive growth factors;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Chao-Yang Hospital, Capital Medical University
RECRUITINGBeijing, Beijing Municipality, China
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Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, China
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Shenzhen University General Hospital
RECRUITINGShenzhen, Guangdong, China
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the First Affiliated Hospital of Soochow University
RECRUITINGSuzhou, Jiangsu, China
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the Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, Jiangxi, China
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