Trial Outcomes & Findings for CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia (NCT NCT00290472)

Last Updated: 2014-05-23

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

89 participants

Primary outcome timeframe

Up to 6 years

Results posted on

2014-05-23

Participant Flow

One patient never received protocol treatment and was excluded from analysis.

Participant milestones

Participant milestones
Measure	Aggressive B-cell Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.	Follicular Lymphoma Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.	Chronic Lymphocytic Leukemia Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Overall Study STARTED	32	39	18
Overall Study COMPLETED	32	39	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CCI-779 in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aggressive B-cell Lymphoma n=32 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.	Follicular Lymphoma n=39 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.	Chronic Lymphocytic Leukemia n=18 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.	Total n=89 Participants Total of all reporting groups
Age, Continuous	67 years n=99 Participants	59 years n=107 Participants	57 years n=206 Participants	61 years n=7 Participants
Sex: Female, Male Female	15 Participants n=99 Participants	15 Participants n=107 Participants	7 Participants n=206 Participants	37 Participants n=7 Participants
Sex: Female, Male Male	17 Participants n=99 Participants	24 Participants n=107 Participants	11 Participants n=206 Participants	52 Participants n=7 Participants

PRIMARY outcome

Timeframe: Up to 6 years

Outcome measures

Outcome measures
Measure	Aggressive B-cell Lymphoma n=32 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.	Follicular Lymphoma n=39 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.	Chronic Lymphocytic Leukemia n=18 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Objective Overall Response Rate	28.1 percentage of participants	53.8 percentage of participants	11.1 percentage of participants

PRIMARY outcome

Timeframe: Up to 6 years

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.

Outcome measures

Outcome measures
Measure	Aggressive B-cell Lymphoma n=9 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.	Follicular Lymphoma n=21 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.	Chronic Lymphocytic Leukemia n=2 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Duration of Response	2.4 Month Interval 2.1 to 28.4	13.3 Month Interval 6.2 to 16.5	NA Month Chronic Lymphocytic Leukemia group had no progression events.

PRIMARY outcome

Timeframe: Up to 6 years

The overall survival was evaluated using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Aggressive B-cell Lymphoma n=32 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.	Follicular Lymphoma n=39 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.	Chronic Lymphocytic Leukemia n=18 Participants Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
Overall Survival	7.3 Month Interval 4.3 to 18.1	NA Month The median Overall Survival and the associated 95% CI was not reached.	31.5 Month Interval 9.5 to The upper limit of the 95% CI interval was undetermined due to the heavy censoring.

Adverse Events

Temsirolimus

Serious events: 21 serious events

Other events: 89 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Temsirolimus n=89 participants at risk All patients
Infections and infestations Anorectal infection	1.1% 1/89
Metabolism and nutrition disorders Anorexia	1.1% 1/89
Musculoskeletal and connective tissue disorders Arthralgia	1.1% 1/89
Cardiac disorders Atrial fibrillation	1.1% 1/89
Cardiac disorders Cardiac disorder	1.1% 1/89
General disorders Chest pain	1.1% 1/89
General disorders Death	1.1% 1/89
Metabolism and nutrition disorders Dehydration	1.1% 1/89
Gastrointestinal disorders Dysphagia, esophagitis, odynophagia	1.1% 1/89
Respiratory, thoracic and mediastinal disorders Dyspnea	2.2% 2/89
Gastrointestinal disorders Esophagitis	1.1% 1/89
General disorders Fatigue	1.1% 1/89
General disorders Fever	2.2% 2/89
Gastrointestinal disorders Hemorrhage	1.1% 1/89
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 2/89
Infections and infestations Pneumonia	2.2% 2/89
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.5% 4/89
Injury, poisoning and procedural complications Postoperative hemorrhage	1.1% 1/89
General disorders Pyrexia	1.1% 1/89
Renal and urinary disorders Renal/Genitourinary-other	1.1% 1/89
Infections and infestations Respiratory tract infection NOS	1.1% 1/89
Infections and infestations Skin infection	2.2% 2/89
Gastrointestinal disorders Stomatitis/pharyngitis	1.1% 1/89
Vascular disorders Thrombosis/ embolism	1.1% 1/89
Infections and infestations Tooth infection	1.1% 1/89
Renal and urinary disorders Urinary retention	1.1% 1/89
Infections and infestations Vulvitis	1.1% 1/89
Gastrointestinal disorders Oseophagitis NOS	1.1% 1/89

Other adverse events

Other adverse events
Measure	Temsirolimus n=89 participants at risk All patients
Gastrointestinal disorders Abdominal pain	14.6% 13/89
Investigations Alanine aminotransferase increased	30.3% 27/89
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	18.0% 16/89
Metabolism and nutrition disorders Anorexia	24.7% 22/89
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 5/89
Investigations Aspartate aminotransferase increased	38.2% 34/89
Musculoskeletal and connective tissue disorders Back pain	7.9% 7/89
Investigations Blood alkaline phosphatase intreased	25.8% 23/89
Investigations Blood creatinine increased	10.1% 9/89
Musculoskeletal and connective tissue disorders Bone pain	12.4% 11/89
Investigations CD4 lymphocytes decreased	5.6% 5/89
General disorders Chills	5.6% 5/89
Gastrointestinal disorders Constipation	15.7% 14/89
Respiratory, thoracic and mediastinal disorders Cough	34.8% 31/89
General disorders Death	24.7% 22/89
Gastrointestinal disorders Diarrhea	27.0% 24/89
General disorders Disease progression	9.0% 8/89
Nervous system disorders Dizziness	11.2% 10/89
Gastrointestinal disorders Dry mouth	5.6% 5/89
Respiratory, thoracic and mediastinal disorders Dyspnea	22.5% 20/89
General disorders Ear, nose and throat examination abnormal	28.1% 25/89
General disorders Edema	32.6% 29/89
General disorders Edema : limb	6.7% 6/89
Eye disorders Eye disorder	5.6% 5/89
Eye disorders Eye problem	6.7% 6/89
General disorders Fatigue	62.9% 56/89
General disorders Fever	16.9% 15/89
General disorders General symptom	5.6% 5/89
Nervous system disorders Headache	21.3% 19/89
Blood and lymphatic system disorders Hemoglobin	70.8% 63/89
Blood and lymphatic system disorders Hemorrhage nasal	9.0% 8/89
Metabolism and nutrition disorders Hypercholesterolemia	49.4% 44/89
Metabolism and nutrition disorders Hyperglycemia	56.2% 50/89
Metabolism and nutrition disorders Hyperkalemia	6.7% 6/89
Metabolism and nutrition disorders Hypertriglyceridemia	66.3% 59/89
Metabolism and nutrition disorders Hypoalbuminemia	27.0% 24/89
Metabolism and nutrition disorders Hypocalcemia	22.5% 20/89
Metabolism and nutrition disorders Hypokalemia	28.1% 25/89
Metabolism and nutrition disorders Hypomagnesemia	9.0% 8/89
Metabolism and nutrition disorders Hyponatremia	13.5% 12/89
Metabolism and nutrition disorders Hypophsphatemia	21.3% 19/89
Vascular disorders Hypotension	6.7% 6/89
Infections and infestations Infection	23.6% 21/89
Psychiatric disorders Insomnia	7.9% 7/89
Blood and lymphatic system disorders Leukopenia	73.0% 65/89
Blood and lymphatic system disorders Lymphopenia	47.2% 42/89
Nervous system disorders Memory impairment	5.6% 5/89
Psychiatric disorders Mood alteration-depression	6.7% 6/89
Musculoskeletal and connective tissue disorders Muscle weakness	13.5% 12/89
Musculoskeletal and connective tissue disorders Myalgia	13.5% 12/89
Gastrointestinal disorders Nausea	21.3% 19/89
Nervous system disorders Neuropathy-sensory	18.0% 16/89
Investigations Neutrophil count	58.4% 52/89
Gastrointestinal disorders Oral pain	10.1% 9/89
Musculoskeletal and connective tissue disorders Pain in extremity	15.7% 14/89
General disorders Pain - other	6.7% 6/89
Investigations Platelet count decreased	82.0% 73/89
Renal and urinary disorders Proteinuria	6.7% 6/89
Skin and subcutaneous tissue disorders Pruritus	5.6% 5/89
General disorders Pyrexia	6.7% 6/89
Skin and subcutaneous tissue disorders Rash desquamating	28.1% 25/89
Skin and subcutaneous tissue disorders Rash/dermatitis	22.5% 20/89
Gastrointestinal disorders Stomatitis/ pharyngitis	32.6% 29/89
General disorders Sweating	6.7% 6/89
Gastrointestinal disorders Taste alteration	9.0% 8/89
Infections and infestations Upper respiratory infection	5.6% 5/89
Infections and infestations Urinary tract infection	6.7% 6/89
Gastrointestinal disorders Vomiting	12.4% 11/89
Respiratory, thoracic and mediastinal disorders Pharyngolaryngea	9.0% 8/89

Additional Information

Dr. Sonali M. Smith

University of Chicago Comprehensive Cancer Center

Phone: 7738342895

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60