Treatment for relapsed or refractory T-cell acute leukemia/lymphoma
Venetoclax Combined With HAG Regimen in Treating Adult Relapse/Refractory Acute T Cell Lymphoblastic Leukemia/Lymphoma: A Phase II, Single Arm and Multicenter Study
This study is testing a new combination treatment for people with relapsed or hard-to-treat T-cell acute leukemia or lymphoma to see if it can help them go into complete remission.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 14 Years to 74 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06742463 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of a combination therapy using Venetoclax, Homoharringtonine, Cytarabine, and G-CSF in patients with relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). It is a prospective, single-arm, phase II study aiming to enroll 50 participants. The primary goal is to achieve complete remission, with or without recovery of peripheral blood cells. The study addresses a critical need for effective treatments in a patient population with a low overall survival rate.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 75 years diagnosed with relapsed or refractory T-ALL/LBL.
Not a fit: Patients with known central nervous system involvement or significant organ dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve remission rates for patients with relapsed or refractory T-ALL/LBL.
How similar studies have performed: Other studies have shown promise in treating T-ALL/LBL with novel combinations, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Before enrollment, a diagnosis of newly diagnosed T-cell acute leukemia/lymphoma.The diagnostic criteria refer to the 2022 WHO classification; 2. Age ≥ 14 years,\<75 years; 3. Clincally diagnosed as relapsed or refractory T-ALL/LBL; 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Expected survival time ≥ 2 months; 6. No organ dysfunction that would restrict the use of this protocol during the screening period; 7. Understand the study and sign the informed consent form. Exclusion Criteria: * 1\. Patients with known central nervous system (CNS) involvement of T-ALL/LBL; 2. Diseases with abnormal heart, lung, liver, kidney, or other organ functions that may limit the patient's participation in this trial (including but not limited to severe infections, uncontrolled diabetes, severe heart failure or angina, active pulmonary tuberculosis, asthma, COPD, bronchiectasis, etc.) 3. Cardiac ultrasound LVEF \< 45%; 4. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer; 5. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN; 6. Known HIV infection; 7. Conditions affecting the use of the study drug as assessed by the investigator; 8. Inability to understand or comply with the study protocol.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Jie Jin, M.D.
- Email: jiej0503@163.com
- Phone: +8657187236896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.