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

Chronic Lymphocytic Leukemia Clinical Trial

Official title:

A Phase 2, Open Label Study of AT-101 in Combination With Rituximab in Patients With Relapse or Refractory Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00286780
• Other study ID #: AT-101-CS-008
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2006
• Last updated: August 12, 2010
• Start date: January 2006
• Est. completion date: November 2007

Study information

• Verified date: August 2010
• Source: Ascenta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

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

Locations

Country	Name	City	State
United States	UCSD Moores Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ascenta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of AT-101 in combination with rituximab		5 months for each patient; 20 months entire study	No
Secondary	Preliminary efficacy of AT-101 in combination with rituximab		5 months	No