NCT05660473 Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
| NCT ID | NCT05660473 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-08-01 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2022-08-01 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
Eligibility Criteria
Inclusion Criteria: * De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics and molecular biology according to WHO classification * Age: 14 -60 years * Male or female * ECOG Performance Status 0-2 * Adequate end organ function as defined by: Total bilirubin ≤ 1.5 x upper limit of normal（ULN）; serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤ 2.5 x ULN or ≤5 x ULN if leukemic involvement of the liver is present; Creatinine ≤ 1.5 x ULN; Serum amylase and lipase ≤ 1.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related; normal electrolytes: Potassium ≥ LLN; Magnesium ≥ LLN; Phosphorus ≥ LLN; Cardiac color Doppler ultrasound ejection fraction ≥ 45%; * Subject has provided written informed consent prior to any screening procedure Exclusion Criteria: * Burkitt lymphoma/leukemia * Acute Leukemia of Ambiguous Lineage * Female patients who are pregnant or breast feeding * Uncontrolled active serious infections that could, in the investigator's opinion, potentially interfere with the completion of treatment * History of pancreatitis * Poorly controlled diabetes, defined as glycosylated hemoglobin (HbA1c) values of \>7.5%. Patients with preexisting, well-controlled diabetes are not excluded * History of active gastrointestinal bleeding within the last 6 months * History of arterial/venous thrombosis within the last 6 months * Known HIV seropositivity * Any serious psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment
Contact & Investigator
Jianxiang Wang, Dr
PRINCIPAL INVESTIGATOR
Institute of Hematology & Blood Diseases Hospital, China
Frequently Asked Questions
Who can join the NCT05660473 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 60 Years, studying Precursor Cell Lymphoblastic Leukemia-Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05660473 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05660473 currently recruiting?
Yes, NCT05660473 is actively recruiting participants. Contact the research team at wangjx@ihcams.ac.cn for enrollment information.
Where is the NCT05660473 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT05660473 clinical trial?
NCT05660473 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Jianxiang Wang, Dr at Institute of Hematology & Blood Diseases Hospital, China. The trial plans to enroll 100 participants.
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