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| Sponsor: | Gilead Sciences |
|---|---|
| Information provided by: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01282424 |
Purpose
The purpose of this study is to evaluate the efficacy and safety of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate.
| Condition | Intervention | Phase |
|---|---|---|
|
Indolent Non-Hodgkin Lymphoma Follicular Lymphoma Small Lymphocytic Lymphoma Lymphoplasmacytoid Lymphoma Marginal Zone Lymphoma |
Drug: CAL-101 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
This is a Phase 2, open-label, single-arm, 2-stage, efficacy, safety, and pharmacodynamic study of CAL-101 in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy.
Eligible patients will initiate oral therapy with CAL-101 at a starting dose of 150 mg taken twice per day. Treatment with CAL-101 can continue in compliant patients as long as the study is still ongoing and the patients appear to be benefiting from treatment with acceptable safety.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following:
Exclusion Criteria:
Contacts and Locations
Show 46 Study Locations| Study Director: | Albert Yu, MD | Calistoga Pharmaceuticals, Inc. |
More Information
| Responsible Party: | Langdon Miller, M.D., VP Clinical Research, Oncology, Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01282424 History of Changes |
| Other Study ID Numbers: | 101-09, 2010-022155-33 |
| Study First Received: | January 21, 2011 |
| Last Updated: | April 24, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
indolent Non-Hodgkin Lymphoma Non-Hodgkin Lymphoma iNHL NHL CAL-101 PI3K |
Phosphatidylinositol 3-kinase Follicular Lymphoma (FL) Small lymphocytic lymphoma (SLL) Lymphoplasmacytoid lymphoma (LPL) Marginal zone lymphoma (MZL) |
|
Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Leukemia, B-Cell Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |