A Phase II Study of Ofatumumab-Based Induction Chemoimmunotheraphy Followed by Consolidation Ofatumumab Immunotherapy in Previously Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
OUTLINE:
Patients with adverse interphase cytogenetics (11q22 or 17p13 deletion) receive FCO
induction therapy:
- Ofatumumab is given IV on day 1 (300 mg) and day 8 (1000 mg) of course 1 and on day 1
(1000 mg) of all subsequent courses.
- Fludarabine phosphate (25mg/m2/d) and cyclophosphamide (250mg/m2/d) are given IV on
days 2 through 4 of course 1 and on days 1 through 3 of all subsequent courses.
Patients age 70 or older will be given reduced doses of fludarabine (20mg/m2/d) and
cyclophosphamide (150mg/m2/d).
- Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression.
Patients without adverse interphase cytogenetics receive FO induction therapy:
- Ofatumumab is given IV on day 1 (300mg) and day 8 (1000mg) of course 1 and on day 1
(1000mg) of all subsequent courses.
- Fludarabine phosphate (25mg/m2/d) is given IV on days 2 through 6 of course 1 and on
days 1 through 5 of all subsequent courses.
- Treatment repeats every 28 days for up to 6 courses in the absence of disease
progression.
All patients are evaluated for minimal residual disease (MRD) by four-color flow cytometric
analysis of the peripheral blood after completion of FO or FCO induction therapy, and are
subsequently stratified into two groups:
- Patients who are MRD-positive and without evidence of disease progression proceed to
consolidation therapy beginning approximately 5 months after completion of induction
therapy, consisting of ofatumumab (1000mg) given IV on day 1 of all courses. Treatment
repeats every 2 months for up to 4 courses in the absence of disease progression.
Patients are followed clinically 2 and 6 months after the last dose of ofatumumab is
given, and then every 6 months thereafter.
- Patients who are MRD-negative and without evidence of disease progression are followed
clinically every 4 months for 1 year and every 6 months thereafter.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
2-year progression -free survival rate
2 years
No
Mohammed Z Farooqui, D.O.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
100141
NCT01145209
June 2010
December 2015
Name | Location |
---|---|
National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |