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

• 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: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Astex Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Leukemia; Lymphoma
• Interventions: Biological: rituximab; Drug: cyclophosphamide; Drug: pentostatin
• Enrollment: 49

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	All Patients
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

Baseline Characteristics

Arm/Group Title		All Patients
Arm/Group Description		All patients who received cyclophosphamide, pentostatin and rituximab
Overall Number of Baseline Participants		49
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%

Outcome Measures

1. Primary Outcome

Title	Overall Objective Response
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	All Patients
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%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	All Patients
Arm/Group Description	All patients who received cyclophosphamide, pentostatin and rituximab
All-Cause Mortality
	All Patients
	Affected / at Risk (%)
Total	--/--
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
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

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Renier Brentjens
• Organization: Memorial Sloan Kettering Cancer Center
• Phone: 1212-639-7053
• EMail: brentjer@mskcc.org

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00541034
• 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