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A Phase II Study of CCI-779 in B-cell Lymphoma and CLL

Phase 2
18 Years
Not Enrolling
B-cell Chronic Lymphocytic Leukemia, Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Malignant Neoplasm, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma, Recurrent Adult Diffuse Large Cell Lymphoma, Recurrent Adult Diffuse Mixed Cell Lymphoma, Recurrent Adult Diffuse Small Cleaved Cell Lymphoma, Recurrent Adult Immunoblastic Large Cell Lymphoma, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Grade 3 Follicular Lymphoma, Recurrent Marginal Zone Lymphoma, Recurrent Small Lymphocytic Lymphoma, Refractory Chronic Lymphocytic Leukemia, Splenic Marginal Zone Lymphoma, Waldenström Macroglobulinemia

Thank you

Trial Information

A Phase II Study of CCI-779 in B-cell Lymphoma and CLL


I. Determine the complete and partial response rate in patients with recurrent or refractory
B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia treated with CCI-779.

II. Determine the toxicity and safety of this drug in these patients. III. Correlate the
degree of activation of P13/AKT/mTOR pathway and levels of CDK inhibitors with response in
patients treated with this drug.

IV. Correlate CCI-779 induced inactivation of mTOR with response in these patients.

OUTLINE: Patients are stratified according to disease (aggressive lymphoma [group A] vs
follicular lymphoma [group B] vs small lymphocytic lymphoma or chronic lymphocytic leukemia
[group C]).

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 8 weeks.

Inclusion Criteria:

- Histologically or cytologically confirmed B-cell non-Hodgkin's lymphoma, including
the following subtypes:

- Aggressive B-cell lymphoma (Group A)

- Diffuse large B-cell lymphoma

- Transformed lymphoma

- Follicular lymphoma (Group B)

- Small lymphocytic lymphoma

- Chronic lymphocytic leukemia (CLL) (Group C)

- Other B-cell small lymphocytic disorders

- No mantle cell lymphoma

- No potentially curative treatment options because of lack of response, relapse, or

- Relapsed or refractory disease

- Patients with refractory disease (i.e., less than a partial response to the last
treatment) must have received no more than 3 prior regimens (group A)

- Patients with sensitive disease (i.e., at least a partial response to the last
treatment) must have received no more than 4 prior regimens (group A)

- Patients who have failed prior autologous transplantation are eligible (group A)

- No more than 5 prior regimens (groups B and C)

- The salvage regimen, conditioning regimen, and any maintenance therapy are
considered 1 regimen

- Prior rituximab or alemtuzumab is not considered prior therapy

- No limitation to the amount of prior radiotherapy

- No CNS involvement

- Performance status: ECOG 0-2 OR Karnofsky 60-100%

- Life expectancy more than 3 months

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No prior 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 active malignancy except nonmelanoma skin cancer or carcinoma in situ of the
cervix Completed therapy and considered < 30% risk of relapse

- No other concurrent uncontrolled illness

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No concurrent prophylactic hematopoietic colony-stimulating factors

- No concurrent pegfilgrastim

- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
and recovered

- More than 4 weeks since prior radiotherapy and recovered

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent unconventional therapies, food, or vitamin supplements containing
Hypericum perforatum (St. John's wort)

- No other concurrent known inducers of CYP3A4

- No other concurrent investigational agents

- No other concurrent anticancer therapy

- Measurable disease*

- At least 1 unidimensionally measurable lesion >= 20 mm by conventional
techniques OR >= 10 mm by spiral CT scan [Note: *Only bone marrow or peripheral
blood involvement required for CLL and Waldenstrom's macroglobulinemia ]

- Absolute neutrophil count >= 1,000/mm3

- Bilirubin =< 1.5 times upper limit of normal (ULN)

- AST and ALT =< 2.5 times ULN

- Creatinine =< 1.5 times ULN

- Fasting cholesterol =< 350 mg/dL

- Fasting triglycerides =< 400 mg/dL

- Platelet count >= 50, 000/mm3 (> 20,000/mm3 for patients with thrombocytopenia due to
bone marrow involvement)

Type of Study:


Study Design:

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

Outcome Measure:

Objective overall response rate

Outcome Time Frame:

Up to 6 years

Safety Issue:


Principal Investigator

Sonali Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

Related Keywords:

  • B-cell Chronic Lymphocytic Leukemia
  • Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
  • Malignant Neoplasm
  • Nodal Marginal Zone B-cell Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Adult Diffuse Large Cell Lymphoma
  • Recurrent Adult Diffuse Mixed Cell Lymphoma
  • Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
  • Recurrent Adult Immunoblastic Large Cell Lymphoma
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Small Lymphocytic Lymphoma
  • Refractory Chronic Lymphocytic Leukemia
  • Splenic Marginal Zone Lymphoma
  • Waldenström Macroglobulinemia
  • Burkitt Lymphoma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Waldenstrom Macroglobulinemia
  • Lymphoma, B-Cell
  • Lymphoma, Large-Cell, Immunoblastic
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Lymphoma, B-Cell, Marginal Zone



University of IowaIowa City, Iowa  52242
Loyola University Medical CenterMaywood, Illinois  60153
Ingalls Memorial HospitalHarvey, Illinois  60426
Central Illinois Hematology Oncology CenterSpringfield, Illinois  62701
La Grange Memorial HospitalLa Grange, Illinois  60525
Decatur Memorial HospitalDecatur, Illinois  62526
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
M D Anderson Cancer CenterHouston, Texas  77030
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Froedtert and the Medical College of WisconsinMilwaukee, Wisconsin  53226
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Oncology Care Associates PLLCSt. Joseph, Michigan  49085
Evanston Hospital CCOPEvanston, Illinois  60201