A phase I/II trial of Obinutuzumab, ABT-199 (GDC-0199) plus Ibrutinib in Relapsed / Refractory Mantle Cell Lymphoma patients (OAsIs)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516750-21-00

Acronym

RC14_0048

Enrollment

Registered

2024-10-18

Start date

2015-10-14

Completion date

2025-05-13

Last updated

2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with relapsed / refractory Mantle Cell Lymphoma

Brief summary

Step A : The occurrence of unacceptable toxicity (definition p35) of the combination of GA101 and Ibrutinib during the first cycle of treatment. Step B : The occurrence of unacceptable toxicity (definition p35) of the combination of GA101 and Ibrutinib plus GDC-0199 during the cycle 2 in terms of Dose-Limiting Toxicities (DLTs). Step C : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib plus GDC-199 at the end of the cycle 2

Detailed description

• Safety (type, frequency, severity, and relationship of adverse events to study treatment), • Incidence of Serious Adverse Event (SAE), Adverse Event (AE) and laboratory abnormalities., • Incidence and severity of tumor lysis syndrome, • Time to progression and overall survival, • Response (CR, PR, SD, PD) and overall response (CR+ PR) rates

Interventions

DRUGIbrutinib

DRUGOBINUTUZUMAB

DRUGGDC-0199

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Step A : The occurrence of unacceptable toxicity (definition p35) of the combination of GA101 and Ibrutinib during the first cycle of treatment. Step B : The occurrence of unacceptable toxicity (definition p35) of the combination of GA101 and Ibrutinib plus GDC-0199 during the cycle 2 in terms of Dose-Limiting Toxicities (DLTs). Step C : The occurrence of unacceptable toxicity of the combination of GA101 and Ibrutinib plus GDC-199 at the end of the cycle 2	—

Measure

Time frame

—

Secondary

Measure	Time frame
• Safety (type, frequency, severity, and relationship of adverse events to study treatment), • Incidence of Serious Adverse Event (SAE), Adverse Event (AE) and laboratory abnormalities., • Incidence and severity of tumor lysis syndrome, • Time to progression and overall survival, • Response (CR, PR, SD, PD) and overall response (CR+ PR) rates	—

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026