Phase 2 Safety and Efficacy Study of AT-101 in Combination With Rituximab in Patients With Chronic Lymphocytic Leukemia

NCT00286780 | Completed Phase 2

• 1 other identifier: AT-101-CS-008
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label Phase 2 study to evaluate the safety and efficay of AT-101 in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.

Conditions

Chronic Lymphocytic Leukemia

Keywords

AT101; AT-101; cancer; lymphoctic; lukemia; Rituximab

Outcome Measures

Primary Outcomes (1)

• Safety of AT-101 in combination with rituximab

  5 months for each patient; 20 months entire study

Secondary Outcomes (1)

• Preliminary efficacy of AT-101 in combination with rituximab

  5 months

Study Arms (1)

1

EXPERIMENTAL

Drug: AT-101

Interventions

AT-101 DRUG

80 mg of AT-101 once daily for three days every other week, 375 mg/m2 of rituximab weekly for up to 12 weeks

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of CLL as defined by the NCI-working group
• Previous treatment with standard systemic chemotherapy or immunotherapy.
• Disease progression or relapse after treatment.
• Indication for treatment as defined by the NCI Working Group Guidelines (Cheson, 1996)
• ECOG performance status ≤ 2
• Adequate liver and renal and bone marrow function

You may not qualify if:

• Treatment of CLL with chemotherapy, monoclonal antibody or radiotherapy within 60 days prior to entering the study. Acute toxicities from prior therapy must have resolved to Grade ≤ 1.
• Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
• Severe or debilitating pulmonary disease (dyspnea at rest, significant shortness of breath, COPD)
• Active secondary malignancy or history of other malignancy within the last five years
• Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral hepatitis (A, B or C).
• Patients who are contraindicated for treatment with rituximab
• Diagnosis of prolymphocytic leukemia, hairy cell leukemia, leukemic phase of non-Hodgkin's lymphoma, or other non-B-CLL B-cell malignancy;
• T-CLL or other T-cell malignancy

Sponsors & Collaborators

• Ascenta Therapeutics: lead

Study Sites (1)

UCSD Moores Cancer Center

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Neoplasms

Interventions

gossypol acetic acid

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Kipps, MD, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: January 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: August 13, 2010

Record last verified: 2010-08

Locations

US (1)