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New treatment option for Intensive Chemotherapy Unfit
Official title Alternating Regimen of VA and Low-dose CHA in the Treatment of Unfit Newly Diagnosed AML
ClinicalTrials.gov ID: NCT07172204
What this study is testing
What is Alternately treated with VA/low CHA regimen?
Alternately treated with VA/low CHA regimen is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for intensive chemotherapy unfit.
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 II trial tests how well VA alternating with low-dose CHA works in treating unfit patients with newly diagnosed acute myeloid leukemia (AML). This is a prospective, multi-centers, single arm phase II study aimed to overcome VEN resistance and achieve greater MRD negative rate, providing better control of treatment for unfit AML.
- 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 and older
You may be able to join if
- 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:
You likely can't join if
- 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...
- GI conditions impairing oral drug absorption: Dysphagia; short-gut syndrome; gastroparesis or related disorders;
- Uncontrolled active infection;
See the full eligibility 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.
- 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 (\ 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Shenzhen, Guangdong, China
- Suzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Shenzhen, Guangdong, China; Suzhou, Jiangsu, China; Nanchang, Jiangxi, China; Hangzhou, Zhejiang, China. 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.