Trial Outcomes & Findings for Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia (NCT NCT00436904)

NCT ID: NCT00436904

Last Updated: 2011-12-01

Results Overview

Confirmed response is defined as a \> 50% decrease in clinical symptoms from baseline and recovery from blood counts.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 30 participants
• Primary outcome timeframe: Up to 6 months
• Results posted on: 2011-12-01

Participant Flow

Participant milestones

Measure	Alemtuzumab + Rituximab Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alemtuzumab and Rituximab in Treating Patients With High-Risk, Early-Stage Chronic Lymphocytic Leukemia

Baseline characteristics by cohort

Measure	Alemtuzumab + Rituximab n=30 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Age Continuous	61 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants
Performance Score 0 - Fully Active	27 participants n=5 Participants
Performance Score 1 - Ambulatory, restricted strenuous activity	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 6 months

Population: Number of patients with a confirmed response out of total patients evaluable for response.

Confirmed response is defined as a > 50% decrease in clinical symptoms from baseline and recovery from blood counts.

Outcome measures

Measure	Alemtuzumab + Rituximab n=30 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Confirmed Response, Defined as Objective Complete Remission or Partial Remission for a Duration of at Least 2 Months	27 participants Interval 23.1 to 29.1

PRIMARY outcome

Timeframe: Weekly for first 6 weeks, then monthly for 6 months, then at 9 and 12 months post registration

Adverse events (AE) that are classified as either possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE version 3.0). The maximum grade for each type of AE will be recorded for each patient. Grade refers to the severity of the AE.>

> Grade 1: Mild AE, Grade 2: Moderate AE, Grade 3: Severe AE, Grade 4: Life-threatening or disabling AE, Grade 5: Death related AE

Outcome measures

Measure	Alemtuzumab + Rituximab n=30 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Number of Participants With Treatment Related Adverse Events Grade 3-4 Hematologic	11 participants
Number of Participants With Treatment Related Adverse Events Grade 3-4 Non-hematologic	3 participants

SECONDARY outcome

Timeframe: Registration to first response (up to 5 years)

Calculated from the date of registration until the first date at which the patient's objective status was classified as a response. In patients who do not achieve a response, time to response will be censored at the patient's last evaluation date. Response is defined the same way as in the response primary outcome measure.

Outcome measures

Measure	Alemtuzumab + Rituximab n=30 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Time to Response	8 Days Interval 8.0 to 14.0

SECONDARY outcome

Timeframe: Up to 5 years

Population: Patients that responded were included in the analysis.

Duration of response is calculated from the date of documented response until the date of progression in the subset of patients who respond to treatment. In patients who have not yet progressed, duration of response will be censored at the patient's last evaluation date.

Outcome measures

Measure	Alemtuzumab + Rituximab n=27 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Duration of Response	14.4 Months Interval 9.3 to 22.5

SECONDARY outcome

Timeframe: Death or last follow-up (up to 5 years)

Population: At analysis time, only 1 out of 30 patients had died. Thus, median survival was not attainable.

Survival is calculated from the date of registration to the date of death due to any cause. In patients who are still alive, survival will be censored at the last date when the patient was known to be alive.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from registration to progression (up to 5 years)

Calculated from date of registration to date of disease progression. In patients that have not progressed, time to disease progression will be censored at the patient's last evaluation date.

Outcome measures

Measure	Alemtuzumab + Rituximab n=30 Participants Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Time to Disease Progression	12.5 Months Interval 7.2 to 19.3

Adverse Events

Alemtuzumab + Rituximab

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Measure	Alemtuzumab + Rituximab n=30 participants at risk Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Infections and infestations Skin infection	3.3% 1/30 • Number of events 1
Nervous system disorders Ischemia-Cerebral	3.3% 1/30 • Number of events 1

Other adverse events

Measure	Alemtuzumab + Rituximab n=30 participants at risk Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
Blood and lymphatic system disorders Anemia	10.0% 3/30 • Number of events 4
Gastrointestinal disorders Diarrhea-No Colostom	20.0% 6/30 • Number of events 8
Gastrointestinal disorders Dyspepsia	6.7% 2/30 • Number of events 2
Gastrointestinal disorders Dysphagia	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Nausea	3.3% 1/30 • Number of events 1
Gastrointestinal disorders Pain-Abdominal	10.0% 3/30 • Number of events 3
Gastrointestinal disorders Vomiting	3.3% 1/30 • Number of events 1
General disorders Fever-No ANC	50.0% 15/30 • Number of events 24
General disorders Rigors	3.3% 1/30 • Number of events 1
Immune system disorders Hypersensitivity	10.0% 3/30 • Number of events 3
Infections and infestations Blood Infection	6.7% 2/30 • Number of events 2
Infections and infestations Bronchial infection	6.7% 2/30 • Number of events 2
Infections and infestations Bronchus infection	3.3% 1/30 • Number of events 1
Infections and infestations Pneumonia	10.0% 3/30 • Number of events 4
Infections and infestations Respiratory tract infection	20.0% 6/30 • Number of events 6
Infections and infestations Skin infection	13.3% 4/30 • Number of events 5
Infections and infestations Upper airway infection	3.3% 1/30 • Number of events 1
Injury, poisoning and procedural complications Appendix injury	3.3% 1/30 • Number of events 1
Investigations Alanine aminotransferase increased	6.7% 2/30 • Number of events 3
Investigations Aspartate aminotransferase increased	6.7% 2/30 • Number of events 2
Investigations Blood bilirubin increased	10.0% 3/30 • Number of events 4
Investigations Leukopenia	63.3% 19/30 • Number of events 55
Investigations Lymphopenia	3.3% 1/30 • Number of events 1
Investigations Neutropenia	40.0% 12/30 • Number of events 24
Metabolism and nutrition disorders Anorexia	3.3% 1/30 • Number of events 1
Musculoskeletal and connective tissue disorders Arthralgia	3.3% 1/30 • Number of events 1
Musculoskeletal and connective tissue disorders Joint effusion	3.3% 1/30 • Number of events 1
Nervous system disorders Olfactory nerve disorder	3.3% 1/30 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pulmonary	3.3% 1/30 • Number of events 1
Skin and subcutaneous tissue disorders Rash/Desquamation	80.0% 24/30 • Number of events 57

Additional Information

Dr. Clive Zent

Mayo Clinic

Phone: 507-284-5362

Email: zent.clive@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place