Phase 2 Study of CAL-101 in Indolent B-Cell Non-Hodgkin Lymphoma
Research type
Research Study
Full title
A Phase 2 Study to Assess the Efficacy and Safety of CAL-101 in Patients with Indolent B-Cell Non-Hodgkin Lymphoma Refractory to Rituximab and Alkylating Agents
IRAS ID
71479
Contact name
Andrew Davies
Sponsor organisation
Calistoga Pharmaceuticals, Inc.
Eudract number
2010-022155-33
Clinicaltrials.gov Identifier
Research summary
This research study is evaluating the safety and effectiveness of an investigational drug, CAL-101, as a possible treatment for patients with indolent non-Hodgkin lymphoma (iNHL) in whom the disease has become difficult to control with available therapies. iNHL is a form of lymphoma, which are cancers of the lymphatic system. This study will be performed at about 60 clinics in the US and Europe, involving 100 to 120 patients. To participate, patients will need to be at least 18 years old and must have iNHL that can be measured with scans. Patients must have already received at least 2 different treatments for iNHL, including the immunotherapy drug called rituximab, and a type of chemotherapy drug known as an alkylating agent. CAL-101 will be provided as tablets to be taken twice per day. Patients can receive CAL-101 for as long as the study is being conducted and they meet the eligibility criteria of the study. Patients will visit the clinic or a laboratory center every 2 weeks during the first 12 weeks of treatment, then every 4 weeks until Week 24 of the study, then every 6 weeks until Week 48 of the study and then every 12 weeks as long as the study remains ongoing. The procedures involved include taking of blood samples, electrocardiogram, radiology scans and physical examinations.
REC name
London - South East Research Ethics Committee
REC reference
11/LO/0218
Date of REC Opinion
12 Apr 2011
REC opinion
Further Information Favourable Opinion