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

NCT05215405 | Unknown

• 1 other identifier: STU-2021-1222
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapsed Childhood ALL; Relapsed Childhood Lymphoblastic Lymphoma

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

Also known as: ABT-199

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

Also known as: ABT-263

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject, parent or guardian must voluntarily sign and date an informed consent.
• Subjects must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL) and have exhausted available therapies of known benefit for ALL/LL. Refractory is defined as persistent disease after at least 2 courses of chemotherapy.
• Subjects must be ≥4 years of age
• Subjects must weight ≥20 kg
• Subjects must have adequate hepatic function:
• a. ALT and AST ≤5 x ULN and bilirubin ≤1.5 x ULN
• Subjects must have normal creatinine for age or have a calculated creatinine clearance ≥ 60mL/min/1.73m2
• Subjects must have adequate performance status:
• Subjects ≤ 16 years of age: Lansky ≥ 50,
• Subjects \> 16 years of age: Karnofsky ≥ 50 or ECOG \<3
• Female subjects of childbearing potential (those who are not postmenopausal for at least 1 year or surgically sterile by bilateral oophorectomy, salpingectomy or hysterectomy) and their male partner must practice as least 1 method of birth control during treatment and through at least 30 days after the last dose of investigational drugs.
• Male subjects who are sexually active with women of child bearing potential must agree to use condoms during treatment.
• Female subjects of childbearing potential must have negative results for serum or urine pregnancy test.

You may not qualify if:

• Subjects who have CNS disease with cranial involvement that requires radiation
• Subjects who are less than 100 days post-transplant, or \>100 days post-transplant with active Graft-versus-host disease (GVHD), or are still continuing post-transplant immunosuppressant therapy within 7 days prior to the first dose of investigational drug.
• Subjects who received any of the following prior to the first dose of investigational drug:
• A strong or moderate CYP3A inhibitor or inducer within 7 days
• Aspirin within 7 days
• Subjects who have active, uncontrolled infection
• Subjects who have not recovered to less than Common Terminology Criteria for Adverse Events (CTCAE) grade 2 from clinically significant adverse effect(s)/toxicity(s) of previous therapy.
• Subjects with malabsorption syndrome or any other condition that precludes enteral administration.
• Female subjects who are pregnant or breastfeeding. Male subjects who are considering fathering a child within approximately 30 days or donating sperm during treatment, within approximately 90 days after the last dose of venetoclax/navitoclax.

Sponsors & Collaborators

• Kathleen Ludwig: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

venetoclax; navitoclax

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Last Updated: February 3, 2025

Record last verified: 2025-01

Locations

US (1)