Phase II Trial of Pentostatin, Cyclophosphamide, and Ofatumumab For Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL)
PRIMARY OBJECTIVES:
I. Arm A: To assess the rate of complete response using pentostatin, cyclophosphamide, and
ofatumumab in patients with previously untreated CLL or SLL requiring therapy.
II. Arm B: To assess the treatment-free survival rate at 18 months using
pentostatin,cyclophosphamide, and ofatumumab induction therapy followed by ofatumumab
consolidation in patients with previously untreated CLL or SSLL requiring therapy.
SECONDARY OBJECTIVES:
I. Arm A and Arm B: To assess the rate of overall response in patients with previously
untreated CLL or SLL requiring therapy and to determine the proportion of patients who
achieve a minimal residual disease (MRD) negative state as assessed by flow cytometry in
each arm independently.
II. Arm A and Arm B: To monitor and assess toxicity in patients with previously untreated
CLL or SLL in each arm independently.
III. Arm A and Arm B: To determine the progression-free survival, treatment-free survival,
and duration of response in each arm independently.
IV. Arm A and Arm B: To determine if molecular prognostic parameters (ZAP-70, CD38,
cytogenetic abnormalities identified by FISH, IgVH mutation status, etc) relate to response
to therapy in each arm independently.
V: Arm B: To assess the rate of complete response using pentostatin, cyclophosphamide, and
ofatumumab induction followed by ofatumumab consolidation in patients with previously
untreated CLL or SLL requiring therapy.
VI: Arm B: To evaluate whether consolidation therapy with ofatumumab after PCO induction
improves the depth of response.
OUTLINE: Patients receive ofatumumab IV on days 1-2 of course 1 and on day 1 of courses 2-6.
Patients also receive pentostatin IV over 30 minutes on day 1, cyclophosphamide IV over 30
minutes on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 21 days
for 6 courses in the absence of disease progression or unacceptable toxicity. Patients on
Arm B receive additional courses with single agent ofatumumab IV on day 1 for 6 courses
(courses 7-12). Treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Arm A: Proportion of complete responses
7 months
No
Tait Shanafelt, M.D.
Study Chair
Mayo Clinic
United States: Food and Drug Administration
MC0983
NCT01024010
August 2010
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |
Duke University Medical Center | Durham, North Carolina 27710 |