Combining Venetoclax with IM2 for treating relapsed T lymphoblastic lymphoma/leukemia
The Efficacy and Safety of Venetoclax Plus IM2 Regimen for Relapsed and Refractory T Lymphoblastic Lymphoma/Leukemia
This study is testing if combining a new drug called Venetoclax with a standard treatment can help people with relapsed T lymphoblastic lymphoma and leukemia feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 14 Years to 45 Years |
| Sex | All |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT05576532 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of combining Venetoclax, a BCL2 inhibitor, with the IM2 regimen for patients suffering from relapsed and refractory T lymphoblastic lymphoma and leukemia. Participants will receive Venetoclax at varying doses alongside a regimen that includes Ifosfamide, Mitoxantrone, and Methotrexate over a specified treatment period. The study aims to determine how well this combination works in improving patient outcomes compared to existing treatment options.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 14 to 45 with relapsed or refractory T lymphoblastic lymphoma or leukemia who have not responded to previous chemotherapy.
Not a fit: Patients with other types of malignancies or those who do not meet the specific eligibility criteria will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with difficult-to-treat T lymphoblastic lymphoma and leukemia.
How similar studies have performed: While there have been studies on Venetoclax for other conditions, this specific combination approach is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria Fourteen to 45 Years Old, Male and female; Expected survival \> 12 weeks; ECOG score 0-2; Confirmed diagnosis of T lymphoblastic lymphoma： a. Patients who do not get a PR with ≥2 induction chemotherapy or a CR with ≥ 4 induction chemotherapy b. Relapsed patients c. For any Patients who failed ASCT/allo-SCT d.The disease can be assessed (BM or CT scan) Confirmed diagnosis of acute T lymphoblastic leukemia (disease involved in BM, and no signs of lymph nodes or mass involvement): Patients who do not get a CR with ≥2 prior induction therapy such as Hyper-A and B regimens. b. relapsed after CR with chemotherapy c. For any Patients failed ASCT/allo-SCT Liver, kidney, and cardiopulmonary functions meet the following requirements: a. Ccr≥60mL/min(Cockcroft Gault) b. Left ventricular ejection fraction \>50%; c.Baseline oxygen saturation\>92%; d. Total bilirubin ≤ 1.5×ULN; e. ALT and AST≤ 3×ULN; Able to understand and sign the Informed Consent Exclusion Criteria: Malignant tumors other than T cell malignancies within 5 years prior to screening, in addition, to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection; Uncontrolled infection including bacterial or virus or fungal disease; patients with positive HBsAg or HBcAb and positive peripheral blood HBV DNA titer detection; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; syphilis positive; Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; Any uncontrolled disease may affect entry Current or history of CNS involvement by malignancy.Known history or presence of clinically relevant central nervous system (CNS) pathology.Patients with a known history or prior diagnosis of other immunologic or inflammatory disease affecting the CNS (such as epilepsy) Pregnant or lactating woman, and a female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; Active or uncontrollable infection requiring systemic therapy Known be allergic to Venetoclax or Ifosfamide or Mitoxantrone or Idarubicin or methotrexate The investigators consider other conditions unsuitable for enrollment. Early relapse(time from the end of IM2 regimen to relapse within 6 months ) post- or refractory to IM2 chemotherapy Patients who may not be able to sign the Informed Consent due to disease,or who do not understand or unwillingness or inability to comply with research requirements
Where this trial is running
Shanghai, Shanghai
- Shanghai General hospital,Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Xianmin G Song — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Xianmin G Song
- Email: shongxm@139.com
- Phone: +862163240090
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.