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New treatment option for Precursor Cell Lymphoblastic Leukemia-Lymphoma
Official title Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT05660473
What this study is testing
What is Vincristine?
Vincristine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for precursor cell lymphoblastic leukemia-lymphoma.
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
- 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).
- Phase 2: a mid-size study of how well it works
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 60
You may be able to join if
- De novo and primary Ph/BCR-ABL1 negative acute lymphoblastic leukemia diagnosed by the bone marrow cytomorphology, immunophenotyping, cytogenetics...
- 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...
You likely can't join if
- 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...
See the full eligibility 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...
- Subject has provided written informed consent prior to any screening procedure
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, 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 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, 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.