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Trial record 6 of 34 for:    "Leukemia" | "Pentostatin"

Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00541034
Recruitment Status : Completed
First Posted : October 8, 2007
Results First Posted : February 27, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astex Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Leukemia
Lymphoma
Interventions Biological: rituximab
Drug: cyclophosphamide
Drug: pentostatin
Enrollment 49
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description All patients who received cyclophosphamide, pentostatin and rituximab
Period Title: Overall Study
Started 49
Completed 46
Not Completed 3
Reason Not Completed
Non-Compliance             3
Arm/Group Title All Patients
Hide Arm/Group Description All patients who received cyclophosphamide, pentostatin and rituximab
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
  63.3%
>=65 years
18
  36.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
12
  24.5%
Male
37
  75.5%
1.Primary Outcome
Title Overall Objective Response
Hide Description The major criteria for determination of response to therapy in patients with CLL include physical examination and examination of the peripheral blood and bone marrow. Radiographic studies are not required but those that were abnormal pre-treatment, will be repeated to document the degree of maximal response.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients who received cyclophosphamide, pentostatin and rituximab
Overall Number of Participants Analyzed 46
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
10
  21.7%
Nodular Response
5
  10.9%
Partial Response (PR)
26
  56.5%
Stable Disease (SD)
4
   8.7%
Progression of Disease (POD)
1
   2.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients who received cyclophosphamide, pentostatin and rituximab
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   18/49 (36.73%) 
Cardiac disorders   
Hypertension  1  2/49 (4.08%) 
General disorders   
Dizziness  1  1/49 (2.04%) 
Dyspnea  1  3/49 (6.12%) 
Facial pain  1  1/49 (2.04%) 
Febrile neutropenia  1  5/49 (10.20%) 
Localized edema  1  1/49 (2.04%) 
Pharyngeal mucositis  1  1/49 (2.04%) 
Pneumonia  1  9/49 (18.37%) 
Immune system disorders   
Immune system disorder  1  1/49 (2.04%) 
Infections and infestations   
Tooth infection  1  1/49 (2.04%) 
Musculoskeletal and connective tissue disorders   
Joint pain  1  1/49 (2.04%) 
Muscle weakness lower limb  1  1/49 (2.04%) 
Muscle weakness upper limb  1  1/49 (2.04%) 
Skin and subcutaneous tissue disorders   
Rash desquamating  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   49/49 (100.00%) 
Blood and lymphatic system disorders   
ALT, SGPT  1  9/49 (18.37%) 
AST, SGOT  1  4/49 (8.16%) 
Hemoglobin  1  42/49 (85.71%) 
Leukocytes (total WBC)  1  39/49 (79.59%) 
Lymphopenia  1  31/49 (63.27%) 
Neutrophils/granulocytes (ANC/AGC)  1  46/49 (93.88%) 
Platelets  1  21/49 (42.86%) 
Gastrointestinal disorders   
Distension/bloating, abdominal  1  3/49 (6.12%) 
Nausea  1  4/49 (8.16%) 
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  6/49 (12.24%) 
Pain  1  3/49 (6.12%) 
Tumor lysis syndrome  1  4/49 (8.16%) 
Metabolism and nutrition disorders   
Albumin, low (hypoalbuminemia)  1  4/49 (8.16%) 
Bilirubin (hyperbilirubinemia)  1  9/49 (18.37%) 
Creatinine  1  3/49 (6.12%) 
Glucose, high (hyperglycemia)  1  32/49 (65.31%) 
Phosphate, low (hypophosphatemia)  1  13/49 (26.53%) 
Potassium, high (hyperkalemia)  1  7/49 (14.29%) 
Sodium, low (hyponatremia)  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Renier Brentjens
Organization: Memorial Sloan Kettering Cancer Center
Phone: 1212-639-7053
EMail: brentjer@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00541034     History of Changes
Other Study ID Numbers: 05-051
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-05051
First Submitted: October 5, 2007
First Posted: October 8, 2007
Results First Submitted: January 9, 2017
Results First Posted: February 27, 2017
Last Update Posted: August 11, 2017