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Spots Global Cancer Trial Database for Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies

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Trial Identification

Brief Title: Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies

Official Title: A Phase II, Open Label, Multicenter Study of Single-Agent AT-101 in Patients With Relapsed or Refractory B-Cell Malignancies (Follicular Lymphoma, Mantle Cell Lymphoma, Diffuse Large Cell Lymphoma, or Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia)

Study ID: NCT00275431

Interventions

AT-101

Study Description

Brief Summary: This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.

Detailed Description: This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies. For the purpose of this study, B-cell malignancies can include one of the following disease sub-types: follicular lymphoma (FL), diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia. Patients will be enrolled according to disease subtype into one of four groups in two stages. The first stage of each group will enrolled 13 patients. If patients within any group experience disease response, an additional 14 patients will be enrolled into that group.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

, Birmingham, Alabama, United States

, San Diego, California, United States

, Atlanta, Georgia, United States

, Chicago, Illinois, United States

, Boston, Massachusetts, United States

, New York, New York, United States

, Rochester, New York, United States

, High Point, North Carolina, United States

, Hilton Head Island, South Carolina, United States

, Memphis, Tennessee, United States

, Burlington, Vermont, United States

Contact Details

Name: Lance Leopold, MD

Affiliation: Ascenta Therapeutics, Inc.

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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