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Compares treatment options for ETP-ALL
Official title Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
ClinicalTrials.gov ID: NCT06361329
What this study is testing
What is Homoharringtonine?
Homoharringtonine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for etp-all.
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
- ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 75
You may be able to join if
- Age ≥14 and \<75 years old.
- Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
- Newly diagnosed patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of ≥3 months.
You likely can't join if
- Patients who are unable to take venetoclax by mouth;
- Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
- Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin \>1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP \>5 ULN; serum creatinine \>1.5 ULN and...
- Known HIV infection;
See the full eligibility criteria
- Age ≥14 and \<75 years old.
- Diagnosed with ETP-ALL (including near-ETP ALL) before enrollment.
- Newly diagnosed patients.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Expected survival of ≥3 months.
- Able to undergo oral treatment with venetoclax.
- No organ dysfunction that would restrict the treatment administered
- Understanding of the study and signing of the informed consent form.
- Men, women of childbearing potential (postmenopausal women must have been amenorrheic for at least 12 months to be considered infertile), and their partners must voluntarily use effective contraception methods as deemed...
- Patients who are unable to take venetoclax by mouth;
- Patients with severe heart, lung, liver, kidney, or other organ dysfunction that may restrict their participation in this trial due to diseases;
- Evidence of other clinically significant uncontrolled condition(s) such as uncontrolled and/or active systemic infection (viral, bacterial or fungal)
- A history of other malignant tumors within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
- Serum total bilirubin \>1.5 ULN (upper limit of normal) (excluding leukemia infiltration); ALT or AST or ALP \>5 ULN; serum creatinine \>1.5 ULN and creatinine clearance rate \<40 mL/min; LVEF \<50%;
- Known HIV infection;
- Known central nervous system leukemia infiltration;
- Gastrointestinal diseases known to affect venetoclax absorption as judged by the investigator;
- Inability to understand or comply with the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
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, 14 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.