Expanded Access Program of Venetoclax and Navitoclax for Pediatric Patients with Relapsed or Refractory ALL or LL

Conditions

• Relapsed Childhood ALL
• Relapsed Childhood Lymphoblastic Lymphoma

Eligibility Criteria

Sex

ALL

Age

4 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Venetoclax — DRUG
  Venetoclax will be administered orally once daily (QD), continuously. Each dose of venetoclax should be taken with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. * Day 1 (200 mg equivalent): * Patients 20 \< 30 kg will take 70 mg * Patients 30 \< 35 kg will take120 mg * Patients 35 to 45 kg will take 200 mg * Day 2 onwards (400 mg equivalent): * Patients 20 \< 30 kg will take 170 mg * Patients 30 \< 35 kg will take 250 mg * Patients 35 to 45 kg will take 400 mg
• Navitoclax — DRUG
  Navitoclax will be administered orally once daily, starting on day 3 of cycle 1 and then may start on day 1 for subsequent cycles. Navitoclax should be taken at the same time each day approximately 24 hours apart. Dosing will be based on the recommended phase II dosing as per the phase I data and subsequent dose recommendations. * Patients 20 \< 45 kg will take 25 mg * Patients 45 kg or more will take 50 mg

Study Details

The overall goal of this expanded access program is to provide Venetoclax and Navitoclax to patients with acute lymphocytic leukemia (ALL) or lymphoblastic lymphoma (LL) who have exhausted standard treatments.

Key Dates

Status verified

Jan 2025

Locations (1)

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