Trial Outcomes & Findings for Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT00541034)
NCT ID: NCT00541034
Last Updated: 2017-08-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
49 participants
Primary outcome timeframe
2 years
Results posted on
2017-08-11
Participant Flow
Participant milestones
| Measure |
All Patients
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
COMPLETED
|
46
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
All Patients
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
Overall Study
Non-Compliance
|
3
|
Baseline Characteristics
Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
All Patients
n=49 Participants
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsThe 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.
Outcome measures
| Measure |
All Patients
n=46 Participants
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
Overall Objective Response
Complete Response (CR)
|
10 Participants
|
|
Overall Objective Response
Nodular Response
|
5 Participants
|
|
Overall Objective Response
Partial Response (PR)
|
26 Participants
|
|
Overall Objective Response
Stable Disease (SD)
|
4 Participants
|
|
Overall Objective Response
Progression of Disease (POD)
|
1 Participants
|
Adverse Events
All Patients
Serious events: 18 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Patients
n=49 participants at risk
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
General disorders
Dizziness
|
2.0%
1/49
|
|
General disorders
Dyspnea
|
6.1%
3/49
|
|
General disorders
Facial pain
|
2.0%
1/49
|
|
General disorders
Febrile neutropenia
|
10.2%
5/49
|
|
Cardiac disorders
Hypertension
|
4.1%
2/49
|
|
Immune system disorders
Immune system disorder
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
2.0%
1/49
|
|
General disorders
Localized edema
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
2.0%
1/49
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.0%
1/49
|
|
General disorders
Pharyngeal mucositis
|
2.0%
1/49
|
|
General disorders
Pneumonia
|
18.4%
9/49
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
2.0%
1/49
|
|
Infections and infestations
Tooth infection
|
2.0%
1/49
|
Other adverse events
| Measure |
All Patients
n=49 participants at risk
All patients who received cyclophosphamide, pentostatin and rituximab
|
|---|---|
|
Blood and lymphatic system disorders
ALT, SGPT
|
18.4%
9/49
|
|
Blood and lymphatic system disorders
AST, SGOT
|
8.2%
4/49
|
|
Metabolism and nutrition disorders
Albumin, low (hypoalbuminemia)
|
8.2%
4/49
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
18.4%
9/49
|
|
Metabolism and nutrition disorders
Creatinine
|
6.1%
3/49
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
6.1%
3/49
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
12.2%
6/49
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
65.3%
32/49
|
|
Blood and lymphatic system disorders
Hemoglobin
|
85.7%
42/49
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
79.6%
39/49
|
|
Blood and lymphatic system disorders
Lymphopenia
|
63.3%
31/49
|
|
Gastrointestinal disorders
Nausea
|
8.2%
4/49
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
93.9%
46/49
|
|
General disorders
Pain
|
6.1%
3/49
|
|
Metabolism and nutrition disorders
Phosphate, low (hypophosphatemia)
|
26.5%
13/49
|
|
Blood and lymphatic system disorders
Platelets
|
42.9%
21/49
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
14.3%
7/49
|
|
Metabolism and nutrition disorders
Sodium, low (hyponatremia)
|
6.1%
3/49
|
|
General disorders
Tumor lysis syndrome
|
8.2%
4/49
|
Additional Information
Dr. Renier Brentjens
Memorial Sloan Kettering Cancer Center
Phone: 1212-639-7053
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place