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Spots Global Cancer Trial Database for Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

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Trial Identification

Brief Title: Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

Official Title: A Multicenter, Open Label, Phase Ib/II Study of Lenalidomide, Venetoclax and Obinutuzumab in Patients With Treatment-Naïve Follicular Lymphoma

Study ID: NCT03980171

Study Description

Brief Summary: The trial will investigate the combination of venetoclax, obinutuzumab and lenalidomide in patients with treatment-naïve follicular lymphoma. Patients will receive induction treatment for 0.5 years with venetoclax, obinutuzumab and lenalidomide followed by maintenance treatment for upto 2 years. Maintenance treatment will be determined by the response at the end of induction. Following completion of treatment patients will be followed up for 3 years after the last patient completes induction treatment.

Detailed Description: This is a phase Ib/II (dose escalation/dose expansion), single-arm multi-centre clinical trial of venetoclax plus obinutuzumab and lenalinomide in patients with treatment-naïve follicular lymphoma. The trial involves an initial dose escalation phase followed by an expansion phase. Patients in both the dose escalation and expansion phases will receive 6 cycles of induction treatment. After patients finish induction treatment, they will undergo PET-CT scan, the results of which will determine further therapy. Patients in CR or SD/PR from the PET-CT scan result will receive up to 2 years of maintenance therapy. Patients in PD from the PET-CT result will not receive any further study treatment. All patients will be followed up for 3 years after the last patient has completed induction treatment.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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