Trial Outcomes & Findings for Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia (NCT NCT00280241)
NCT ID: NCT00280241
Last Updated: 2016-02-04
Results Overview
The number of patients who experience any grade 3-5 toxicity.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Duration of treatment on study
Results posted on
2016-02-04
Participant Flow
Participant milestones
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
55
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=65 Participants
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Age, Customized
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of treatment on studyThe number of patients who experience any grade 3-5 toxicity.
Outcome measures
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=65 Participants
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Tolerability of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL
|
42 participants
|
PRIMARY outcome
Timeframe: Three months after the sixth cycle (9 months)The number of patients who experience a complete clinical response.
Outcome measures
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=63 Participants
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Efficacy of Rituximab, Cyclophosphamide and Fludarabine in Patients With Previously Untreated CLL/SLL
|
46 participants
|
SECONDARY outcome
Timeframe: Five years after starting rituximab, cyclophosphamide and fludarabineThe percentage of participants who are still alive.
Outcome measures
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=65 Participants
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Overall Survival Rate
|
85.5 percentage of participants
Interval 73.9 to 92.2
|
SECONDARY outcome
Timeframe: From complete response to the time of progressive disease, death or last clinical examinationThe length of time for which the complete response is maintained.
Outcome measures
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=37 Participants
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Duration of Response
|
22.3 Months
Interval 5.2 to 42.3
|
Adverse Events
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
Serious events: 26 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=65 participants at risk
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
7.7%
5/65
|
|
Investigations
Leukocytes (total WBC)
|
10.8%
7/65
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
30.8%
20/65
|
|
Investigations
Platelets
|
3.1%
2/65
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
1.5%
1/65
|
|
Cardiac disorders
Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)
|
1.5%
1/65
|
|
Cardiac disorders
Cardiac-ischemia/infarction
|
3.1%
2/65
|
|
General disorders
Edema
|
1.5%
1/65
|
|
Cardiac disorders
Cardiovascular/General-Other
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Prothrombin time (PT)
|
1.5%
1/65
|
|
General disorders
Rigors, chills
|
3.1%
2/65
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.5%
1/65
|
|
Gastrointestinal disorders
Diarrhea
|
3.1%
2/65
|
|
Gastrointestinal disorders
Ileus (or neuroconstipation)
|
1.5%
1/65
|
|
Infections and infestations
Infection without neutropenia
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.1%
2/65
|
|
Infections and infestations
Infection/Febrile Neutropenia-Other
|
4.6%
3/65
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.5%
1/65
|
Other adverse events
| Measure |
FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB
n=65 participants at risk
Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.
Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.
Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.
|
|---|---|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
10.8%
7/65
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
7.7%
5/65
|
|
Ear and labyrinth disorders
Inner ear/hearing
|
1.5%
1/65
|
|
Investigations
Lymphopenia
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Hemoglobin
|
43.1%
28/65
|
|
Investigations
Leukocytes (total WBC)
|
63.1%
41/65
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
38.5%
25/65
|
|
Investigations
Platelets
|
38.5%
25/65
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow-Other
|
1.5%
1/65
|
|
General disorders
Edema
|
9.2%
6/65
|
|
Vascular disorders
Hypotension
|
3.1%
2/65
|
|
Cardiac disorders
Cardiovascular/General-Other
|
3.1%
2/65
|
|
Vascular disorders
Hypertension
|
3.1%
2/65
|
|
General disorders
Fatigue (lethargy, malaise, asthenia)
|
81.5%
53/65
|
|
Investigations
Weight gain
|
3.1%
2/65
|
|
Investigations
Weight loss
|
4.6%
3/65
|
|
General disorders
Constitutional Symptoms-Other
|
4.6%
3/65
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
|
24.6%
16/65
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
18.5%
12/65
|
|
General disorders
Rigors, chills
|
29.2%
19/65
|
|
Vascular disorders
Hot flashes/flushes
|
7.7%
5/65
|
|
Vascular disorders
Flushing
|
3.1%
2/65
|
|
General disorders
Injection site reaction
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
10/65
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives, welts, wheals)
|
7.7%
5/65
|
|
Injury, poisoning and procedural complications
Wound-non-infectious
|
3.1%
2/65
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-Other
|
4.6%
3/65
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.5%
1/65
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
20.0%
13/65
|
|
Metabolism and nutrition disorders
Anorexia
|
30.8%
20/65
|
|
Gastrointestinal disorders
Constipation
|
21.5%
14/65
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
15/65
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
7.7%
5/65
|
|
Gastrointestinal disorders
Flatulence
|
1.5%
1/65
|
|
Gastrointestinal disorders
Nausea
|
60.0%
39/65
|
|
Gastrointestinal disorders
Taste disturbance (dysgeusia)
|
3.1%
2/65
|
|
Gastrointestinal disorders
Gastrointestinal-Other
|
7.7%
5/65
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
12.3%
8/65
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65
|
|
Gastrointestinal disorders
Vomiting
|
21.5%
14/65
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Hemorrhage-Other
|
1.5%
1/65
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.5%
1/65
|
|
Investigations
SGOT (AST) (serum glutamic oxaloacetic transaminase)
|
4.6%
3/65
|
|
Investigations
SGPT (ALT) (serum glutamic pyruvic transaminase)
|
4.6%
3/65
|
|
Investigations
Alkaline phosphatase
|
1.5%
1/65
|
|
Infections and infestations
Infection without neutropenia
|
35.4%
23/65
|
|
Infections and infestations
Infection with unknown ANC
|
4.6%
3/65
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
3.1%
2/65
|
|
Infections and infestations
Wound-infectious
|
1.5%
1/65
|
|
Blood and lymphatic system disorders
Lymphatics-Other
|
1.5%
1/65
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.5%
1/65
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
10.8%
7/65
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.5%
1/65
|
|
Endocrine disorders
Hypothyroidism
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (not due to neuropathy)
|
1.5%
1/65
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal-Other
|
9.2%
6/65
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
9/65
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.8%
9/65
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.5%
1/65
|
|
Nervous system disorders
Memory loss
|
1.5%
1/65
|
|
Nervous system disorders
Neuropathy - motor
|
9.2%
6/65
|
|
Nervous system disorders
Neurology-Other
|
4.6%
3/65
|
|
Psychiatric disorders
Insomnia
|
23.1%
15/65
|
|
Nervous system disorders
Dizziness/lightheadedness
|
10.8%
7/65
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
6.2%
4/65
|
|
Nervous system disorders
Headache
|
21.5%
14/65
|
|
Psychiatric disorders
Mood alteration-depression
|
6.2%
4/65
|
|
Nervous system disorders
Neuropathy-sensory
|
12.3%
8/65
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
1.5%
1/65
|
|
Eye disorders
Conjunctivitis
|
1.5%
1/65
|
|
Eye disorders
Vision-blurred vision
|
4.6%
3/65
|
|
Eye disorders
Ocular/Visual-Other
|
1.5%
1/65
|
|
Nervous system disorders
Neuropathic pain
|
1.5%
1/65
|
|
General disorders
Pain-Other
|
20.0%
13/65
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.2%
4/65
|
|
General disorders
Chest pain (non-cardiac and non-pleuritic)
|
3.1%
2/65
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
10.8%
7/65
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.8%
22/65
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
12.3%
8/65
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
3.1%
2/65
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary-Other
|
9.2%
6/65
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)
|
1.5%
1/65
|
|
Renal and urinary disorders
Dysuria (painful urination)
|
3.1%
2/65
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
6.2%
4/65
|
|
Investigations
Creatinine
|
1.5%
1/65
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place