CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
A Phase II Study of CCI-779 in B-cell Lymphoma and CLL
8 other identifiers
interventional
89
1 country
13
Brief Summary
Drugs used in chemotherapy, such as CCI-779, work in different ways to stop cancer cells from dividing so they stop growing or die. This phase II trial is studying how well CCI-779 works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2004
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
February 11, 2014
CompletedMay 23, 2014
February 1, 2013
6.1 years
February 10, 2006
August 19, 2013
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Objective Overall Response Rate
The 1999 international response criteria (http://www.ncbi.nlm.nih.gov/pubmed/10655437#) as published by Cheson was used for the definition of target lesions and CT scans were used for response assessment. CR(complete response)/CRu(unconfirmed complete response) requires disappearance of all target lesions; PR (partial response) requires \>=50% decrease in the sum of the products of the greatest diameters; Overall Response (OR)=CR/CRu+PR.
Up to 6 years
Duration of Response
Duration of response was the time from date of response to date of progression and evaluated among participants with response. According to the 1999 international response criteria as published by Cheson, progression/progressive disease is defined as \>=50% increase from nadir in the sum of the products of the greatest diameters of any previously identified abnormal node for PRs or nonresponders, or appearance of any new lesion during or at the end of therapy.
Up to 6 years
Overall Survival
The overall survival was evaluated using the Kaplan-Meier estimator.
Up to 6 years
Study Arms (1)
Arm I
EXPERIMENTALPatients 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 ineligibility
- 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)
- +35 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
University of Chicago
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Evanston Hospital CCOP
Evanston, Illinois, 60201, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Adventist La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Central Illinois Hematology Oncology Center
Springfield, Illinois, 60702, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46601, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
Smith SM, van Besien K, Karrison T, Dancey J, McLaughlin P, Younes A, Smith S, Stiff P, Lester E, Modi S, Doyle LA, Vokes EE, Pro B. Temsirolimus has activity in non-mantle cell non-Hodgkin's lymphoma subtypes: The University of Chicago phase II consortium. J Clin Oncol. 2010 Nov 1;28(31):4740-6. doi: 10.1200/JCO.2010.29.2813. Epub 2010 Sep 13.
PMID: 20837940DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonali M. Smith
- Organization
- University of Chicago Comprehensive Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Sonali Smith
University of Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 13, 2006
Study Start
March 1, 2004
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
May 23, 2014
Results First Posted
February 11, 2014
Record last verified: 2013-02