NCT02614066

A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3)

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Kite, A Gilead Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to determine the safety and efficacy of brexucabtagene autoleucel (KTE-X19) in adult participants with relapsed/refractory (r/r) B-precursor acute lymphoblastic leukemia (ALL).

Detailed description

Bridging therapy could be administered at the discretion of the investigator and is recommended for participants with high disease burden at baseline (M3 marrow \[\> 25% leukemic blasts\] or ≥ 1,000 blasts/mm\^3 in the peripheral circulation) to control participant's disease prior to conditioning chemotherapy. Bridging therapy includes: Attenuated VAD: Vincristine non-liposomal (1-2 mg IV weekly) or liposomal (2.25 mg/m\^2 IV weekly), and dexamethasone 20-40 mg IV or oral administration (PO) daily x 3-4 days per week. Optional doxorubicin 50 mg/m\^2 IV x 1 (first week only). Mercaptopurine (6-MP): 50-75 mg/m\^2/day by mouth (administer at bedtime on an empty stomach to improve absorption). Hydroxyurea: Doses titrated between 15-50 mg/kg/day (rounded to the nearest 500 mg capsule and given as a single daily oral dose on a continuous basis). DOMP: Dexamethasone 6 mg/m\^2/day PO (or IV) divided twice daily (BID) Days 1-5, vincristine 1.5 mg/m\^2 (maximum dose 2 mg) IV on Day 1, methotrexate 20 mg/m\^2 PO weekly, 6-MP 50- 75mg/m\^2/day PO daily. Attenuated FLAG/FLAG-IDA: fludarabine 30 mg/m\^2 IV days 1-2, cytarabine 2 g/m\^2 IV days 1-2, G-CSF 5 μg/kg subcutaneously (SC) or IV starts on Day 3 and can continue until day before the start of conditioning chemotherapy. With or without idarubicin 6 mg/m\^2 IV Days 1-2. Mini-hyper CVAD (courses A and/or B): * Course A: Cyclophosphamide 150 mg/m\^2 every 12 hours x 3 days, dexamethasone 20 mg/d IV or PO daily Days 1-4 and 11-14, vincristine 2 mg IV x 1 * Course B: Methotrexate 250 mg/m\^2 IV over 24 hours on Day 1,cytarabine 0.5 g/m\^2 IV every 12 hours x 4 doses on Days 2 and 3. After completion of the Month 24 visit, subjects who received an infusion of KTE-X19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Conditions

• Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	brexucabtagene autoleucel	A single infusion of brexucabtagene autoleucel CAR transduced autologous T cells administered intravenously.
DRUG	Cyclophosphamide	Administered intravenously.
DRUG	Fludarabine	Administered intravenously.

Timeline

• Start date: 2016-03-07
• Primary completion: 2022-07-23
• Completion: 2023-11-03
• First posted: 2015-11-25
• Last updated: 2024-11-19
• Results posted: 2021-11-29

Locations

33 sites across 5 countries: United States, Canada, France, Germany, Netherlands

Regulatory

• FDA-regulated drug study