Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug cocktail aims to beat leukemia in patients too frail for standard chemo

NCT ID NCT07172204

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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;

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Age 60 and older are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Beijing Chao-Yang Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, China

  • Bone Marrow Transplantation Center, the First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • Shenzhen University General Hospital

    RECRUITING

    Shenzhen, Guangdong, China

  • the First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, China

  • the Second Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.