A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblast… (NCT05386576) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)
United States12 participantsStarted 2022-06-16
Plain-language summary
The researchers are doing this study to find out whether combining venetoclax with several different standard chemotherapy drugs used to treat acute lymphoblastic leukemia (ALL) in children is safe and effective in adults with newly diagnosed ALL. Participants in this study will be under the age of 60, and they will have T- or B-cell ALL.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* Adult patients with newly diagnosed Philadelphia chromosome (Ph) negative ALL.
* Patients with T- or B-cell lymphoblastic lymphoma with no bone marrow involvement will also be eligible for the study.
* Age 18-60
* ECOG performance status of 0-2
* Adequate renal function as demonstrated by a calculated creatinine clearance of ≥ 60 ml/min.
* Adequate hepatic function as demonstrated by a total bilirubin ≤ 2.0 mg/dl (unless attributable to Gilbert's disease) and an alkaline phosphatase, AST, and ALT ≤ 4 times the upper limit of normal (unless clinically considered to be related to liver involvement with leukemia)
* Patients with central nervous system (CNS) involvement by ALL are eligible and may receive concomitant treatment with radiation therapy and/or intrathecal chemotherapy in accordance with standard medical practice. For patients with CNS disease, dexamethasone may be temporarily administered instead of prednisone to reduce CNS pressure, at the discretion of the treating physician and after discussion with the MSK PI. Once dexamethasone is no longer needed, prednisone should be given as per protocol for 28 days.
* Negative serum pregnancy test in women of childbearing potential
Exclusion Criteria:
* CML in lymphoid blast crisis, mature B-cell (i.e. Burkitt's) lymphoma or mixed phenotype acute leukemia (MPAL)
* Prior treatments for ALL, except any doses of corticosteroids and hydroxyurea or one dose of vincristine
* Patients who received strong an…
What they're measuring
1
proportion of patients who have a Dose Limiting Toxicities