Trial Outcomes & Findings for Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders (NCT NCT00071396)

Last Updated: 2012-08-07

Results Overview

Overall response categorized as 'Complete Remission,' 'Partial Remission,' or 'No Response.' Blood tests weekly while on active therapy, within 4-6 weeks following last dose of therapy, and every 3 to 6 (+/- month) thereafter as long as on study. Repeat bone marrow biopsy/aspirate with flow cytometry as applicable at the end of first course of therapy, (1 week) within 4-6 weeks following the last dose of therapy and every 6 to 12 months (+/-) thereafter as long as on study.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

48 participants

Primary outcome timeframe

After each 4 week course of treatment

Results posted on

2012-08-07

Participant Flow

Recruitment Period 10/21/02 - 3/27/09; all patients were registered at the University of Texas MD Anderson Cancer Center.

Of 48 patients enrolled, 41 patients were evaluable for response (2 patients withdrew before starting treatment and 2 were ineligible).

Participant milestones

Participant milestones
Measure	Campath-1H + Rituximab Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Overall Study STARTED	44
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Campath-1H + Rituximab Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	2

Baseline Characteristics

Campath-1H Plus Rituximab for CD52- and CD20- Positive Refractory or Relapsed Chronic Lymphoid Disorders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Campath-1H + Rituximab n=44 Participants Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Age Continuous	59 years n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants

PRIMARY outcome

Timeframe: After each 4 week course of treatment

Population: Analysis treated population 41 evaluable patients (44 treated, 3 not evaluable for response).

Outcome measures

Outcome measures
Measure	Campath-1H + Rituximab n=41 Participants Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Overall Response Complete Remission	8 Participants
Overall Response Partial Remission	14 Participants
Overall Response No Response	19 Participants

Adverse Events

Campath-1H + Rituximab

Serious events: 8 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Campath-1H + Rituximab n=44 participants at risk Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
General disorders Fever without neutropenia	2.3% 1/44 • Number of events 1 • 3 years 11 months
Infections and infestations Pneumonia	4.5% 2/44 • Number of events 2 • 3 years 11 months
Infections and infestations Infection	6.8% 3/44 • Number of events 3 • 3 years 11 months
Infections and infestations Febrile Neutropenia	6.8% 3/44 • Number of events 3 • 3 years 11 months
General disorders Fever	4.5% 2/44 • Number of events 2 • 3 years 11 months

Other adverse events

Other adverse events
Measure	Campath-1H + Rituximab n=44 participants at risk Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course. Rituximab 375 mg/m\^2 IV infusion day 1, then 500 mg/m\^2 on days 8, 15 + 22.
Blood and lymphatic system disorders Anemia	13.6% 6/44 • Number of events 6 • 3 years 11 months
General disorders Drug Fever	27.3% 12/44 • Number of events 13 • 3 years 11 months
Respiratory, thoracic and mediastinal disorders dyspnea	9.1% 4/44 • Number of events 4 • 3 years 11 months
General disorders fatigue	22.7% 10/44 • Number of events 10 • 3 years 11 months
General disorders febrile neutropenia	6.8% 3/44 • Number of events 3 • 3 years 11 months
General disorders fever	6.8% 3/44 • Number of events 5 • 3 years 11 months
Cardiac disorders hypotension	11.4% 5/44 • Number of events 5 • 3 years 11 months
Gastrointestinal disorders Nausea	18.2% 8/44 • Number of events 8 • 3 years 11 months
Skin and subcutaneous tissue disorders puritis	15.9% 7/44 • Number of events 7 • 3 years 11 months
Skin and subcutaneous tissue disorders Injection site reaction	11.4% 5/44 • Number of events 8 • 3 years 11 months
Blood and lymphatic system disorders Leukopenia	20.5% 9/44 • Number of events 12 • 3 years 11 months
Blood and lymphatic system disorders Lymphopenia	15.9% 7/44 • Number of events 7 • 3 years 11 months
Infections and infestations neutropenia	6.8% 3/44 • Number of events 5 • 3 years 11 months
General disorders Rigors Chills	40.9% 18/44 • Number of events 21 • 3 years 11 months
Blood and lymphatic system disorders Thrombocytopenia	13.6% 6/44 • Number of events 6 • 3 years 11 months

Additional Information

Alessandra Ferrajoli, MD, BS / Assistant Professor

The University of Texas M. D. Anderson Cancer Center

Phone: 713-745-4613

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place