ETP-ALLPhase 3NCT06361329
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
A Phase 3 study testing Homoharringtonine, venetoclax and Cytarabine in people with ETP-ALL, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
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. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- ETP-ALL
- What is being tested?
- Homoharringtonine, venetoclax and Cytarabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2024to 31 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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 appropriate by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jie Jin, PhD&MD, 13705716779, jiej0503@163.com
About this study
Official title: A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)
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. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
- Conditions
- ETP-ALL
- Being tested
- Homoharringtonine, venetoclax, Cytarabine, G-CSF, Vindesine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomoharringtonineDrug
Intravenous infusion
venetoclaxDrug
Orally by mouth
CytarabineDrug
subcutaneous injection or Intravenous infusion
G-CSFDrug
subcutaneous injection
VindesineDrug
Intravenous infusion
DaunorubicinDrug
Intravenous infusion
cyclophosphamideDrug
Intravenous infusion
DexamethasoneDrug
Intravenous infusion or orally
L-ASPDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| VHAG group | Experimental | Venetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28.
HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L Receives: Drug: Homoharringtonine; Drug: venetoclax; Drug: Cytarabine; Drug: G-CSF |
| Traditional Chemotherapy Regimen group | Active comparator | * VDCLP regimen
* VD(/I) CP regimen
* Hyper CVAD-A regimen
* VDLP regimen Receives: Drug: Cytarabine; Drug: Vindesine; Drug: Daunorubicin; Drug: cyclophosphamide; Drug: Dexamethasone; Drug: L-ASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year EFS
1-year event free survival rate
Measured: 1 year
Secondary outcomes (4)
CR/CRi
Complete remission/complete remission with incomplete count recovery
Measured: At the end of Cycle 1 (up to 42 days)
OS
Overall survival
Measured: through study completion, up to 3 years
MRD
Percentage of participants who converted to MRD < 10^-3 after the first cycle of treatment.
Measured: At the end of Cycle 1 (up to 42 days)
Safety of induction therapy
Adverse events
Measured: At the end of Cycle 1 (up to 42 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start3 Apr 2024
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ETP-ALLStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361329
- Sponsor's protocol ID
- 20240030C
- Status last verified
- Mar 2024
- First submitted
- 1 Apr 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Controlled Clinical Study Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in the Treatment of Adult Newly Diagnosed Early Precursor T-cell Acute Lymphoblastic Leukemia (ETP-ALL)
- ClinicalTrials.gov ID
- NCT06361329
- Acronym / sponsor ID
- 20240030C
- Conditions
- ETP-ALL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VHAG group | Experimental | Drug: Homoharringtonine, Drug: venetoclax, Drug: Cytarabine, Drug: G-CSFVenetoclax: 100mg on day 1, 200mg on day 2, and 400mg on days 3-14, if the blast cells in bone marrow were more than 5% on day 14, the patient continued to receive venetoclax 400mg until day 28. HHT:1.4 mg/m2,2mg maximum daily, intravenously daily from on d1-7 Cytarabine :10 mg/m2 subcutaneously every 12h on d1-14（d10-d14） G-CSF: 100ug/m2 daily on d1-14 if WBC count <10*10E9/L |
| Traditional Chemotherapy Regimen group | Active comparator | Drug: Cytarabine, Drug: Vindesine, Drug: Daunorubicin, Drug: cyclophosphamide, Drug: Dexamethasone, Drug: L-ASP* VDCLP regimen * VD(/I) CP regimen * Hyper CVAD-A regimen * VDLP regimen |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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%;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomoharringtonineIntravenous infusion | Drug | VHAG group |
| venetoclaxOrally by mouth | Drug | VHAG group |
| Cytarabinesubcutaneous injection or Intravenous infusion | Drug | Traditional Chemotherapy Regimen group, VHAG group |
| G-CSFsubcutaneous injection | Drug | VHAG group |
| VindesineIntravenous infusion | Drug | Traditional Chemotherapy Regimen group |
| DaunorubicinIntravenous infusion | Drug | Traditional Chemotherapy Regimen group |
| cyclophosphamideIntravenous infusion | Drug | Traditional Chemotherapy Regimen group |
| DexamethasoneIntravenous infusion or orally | Drug | Traditional Chemotherapy Regimen group |
| L-ASPsubcutaneous injection | Drug | Traditional Chemotherapy Regimen group |
Primary outcome
1-year EFS
Time frame: 1 year
1-year event free survival rate
4 secondary outcomes
CR/CRi
Time frame: At the end of Cycle 1 (up to 42 days)
OS
Time frame: through study completion, up to 3 years
MRD
Time frame: At the end of Cycle 1 (up to 42 days)
Safety of induction therapy
Time frame: At the end of Cycle 1 (up to 42 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
Related trials for ETP-ALL
RecruitingPhase 2
Venetoclax Combined With Azacitidine, Chidamide, Vindesine, and Dexamethasone in Newly Diagnosed ETP-ALL Like Patients
Adult T-cell Leukemia/Lymphoma
RecruitingPhase 2
Venetoclax + Azacytidine for Newly Diagnosed ETP-like ALL and T-ALL With Myeloid Mutations
Early T Acute Lymphoblastic Leukemia, T-Acute Lymphoblastic Leukemia
RecruitingPhase 1/2
Sequential CAR-T Cells Therapy for CD5/CD7 Positive T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma Using CD5/CD7-Specific CAR-T Cells
T Cell Lymphoma, T Cell Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Homoharringtonine, venetoclax and Cytarabine in people with ETP-ALL, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year EFS (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.