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A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling
Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Hodgkin Lymphoma, Refractory Chronic Lymphocytic Leukemia

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Trial Information

A Phase II Study of CCI-779 in Patients With Relapsed, Refractory or Transformed Chronic Lymphocytic Leukemia


I. Determine the activity of CCI-779 in patients with relapsed, refractory, or transformed
chronic lymphocytic leukemia.

OUTLINE: Patients are stratified according to disease (relapsed or refractory chronic
lymphocytic leukemia [CLL] vs transformed CLL).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats
every 28 days for up to 6 courses in the absence of disease progression or unacceptable
toxicity. Patients achieving an objective response may receive 3 consolidation courses of

Inclusion Criteria:

- Diagnosis of chronic lymphocytic leukemia (CLL)

- Relapsed, refractory, or transformed disease

- Relapsed disease defined as symptomatic loss of a prior partial or complete
response to a regimen containing a purine analog and/or a monoclonal
antibody AND evidence of disease progression

- Primary resistant disease defined as failure to achieve an objective
response to a regimen containing a purine analog and/or a monoclonal

- Transformed CLL (Richters transformation), must meet both of the following

- Histologically confirmed lymphoma

- Measurable disease

- No CNS disease

- Performance status - ECOG 0-2

- Bilirubin ≤ 2 mg/dL (unless elevated due to Gilbert's disease)

- SGOT and SGPT < 3 times upper limit of normal

- Creatinine ≤ 2 mg/dL (unless due to organ leukemic involvement)

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV-positive patients allowed provide CD4 counts are normal and no AIDS-defining
disease is present

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to CCI-779

- No ongoing or active infection

- No psychiatric illness or social situation that would preclude study compliance

- No other concurrent uncontrolled illness

- See Disease Characteristics

- No concurrent prophylactic hematopoietic colony-stimulating factors

- See Disease Characteristics

- More than 2 weeks since prior cytotoxic chemotherapy and recovered

- More than 2 weeks since prior radiotherapy and recovered

- No other concurrent investigational or antitumor agents

- No other concurrent cytotoxic agents

- No concurrent combination antiretroviral therapy for HIV-positive patients

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response (CR or PR)

Outcome Description:

Defined as the complete disappearance of all known disease, or a 50% decrease in tumor size using the sum of the product (bi-perpendicular dimensions when available).

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Francis Giles

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Hodgkin Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin



M D Anderson Cancer Center Houston, Texas  77030