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


Phase 2
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety of AT-101 in combination with rituximab

Outcome Time Frame:

5 months for each patient; 20 months entire study

Safety Issue:

No

Principal Investigator

Thomas Kipps, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, San Diego

Authority:

United States: Food and Drug Administration

Study ID:

AT-101-CS-008

NCT ID:

NCT00286780

Start Date:

January 2006

Completion Date:

November 2007

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • AT101
  • AT-101
  • cancer
  • lymphoctic
  • lukemia
  • Rituximab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

UCSD Moores Cancer CenterLa Jolla, California  93093