NCT05386576

A Study of Venetoclax in Combination With Chemotherapy to Treat Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Venetoclax in Combination With Asparaginase-Containing Pediatric-Inspired Chemotherapy in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

All patients will complete Induction I and II of the treatment regimens, consisting of several chemotherapy agents including Peg-ASP. * For Dose Level 1: Venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28 during Induction I. During Induction II, venetoclax will be administered at 400mg daily from days 1-14 and 29-42. * For Dose Level -1: Venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28 during Induction I. During Induction II, venetoclax will be administered at 200mg daily from days 1-14 and 29-42. * Bone marrow aspirate and biopsy will be performed at day 14 of Induction I, after Induction I and Induction II for disease assessment. For those who remain on study after Induction II, they will proceed to consolidation therapy. Consolidation blocks contain 2 Intensification blocks (22 days each) and 2 Re-Induction blocks (43 days each), consisting of several chemotherapy agents including Peg-ASP. * Venetoclax will be administered at a dose of 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-22 during Intensification blocks, and from days 1-14 and 29-42 during Re-Induction blocks. * Bone marrow aspirate and biopsy will be performed after Re-Induction I and Re-Induction II for disease assessment. * Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy. * Patients who remain in MRD negative CR will remain on study and proceed to Maintenance. * Maintenance block contains 4-drug regimen (vincristine, oral methotrexate, oral mercaptopurine, and prednisone) for 2 years. No venetoclax will be administered during this block. Bone marrow aspirate and biopsy will be performed every 3 months during the Maintenance block. Patients who remain in MRD negative CR will remain on study to complete the study treatment. Patients who relapse either with MRD or morphologically will be removed from study to pursue alternative therapy.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Venetoclax	During Induction I, for patients on Dose Level 1, venetoclax will be administered at a dose of 100mg on day 5, 200mg on day 6 and 400mg on days 7-28. For patients on Dose Level 01, venetoclax will be administered at a dose of 100mg on day 5 and 200mg on days 6-28. During Induction II, venetoclax will be administered at either 400mg daily (Dose Level 1) or 200mg daily (Dose Level -1) from days 1-14 and 29-42.

Timeline

• Start date: 2022-06-16
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2022-05-23
• Last updated: 2025-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study