A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL
There are three possible components to the treatment in this study:
Part A - Ofatumumab + HDMP
- A maximum of 4 cycles of 28 days. Ofatumumab and HDMP will be given intravenously.
Ofatumumab will given on days 1, 8, 15 and 22. HDMP will given on days 1, 2, and 3.
Part B - Ofatumumab + Alemtuzumab
- Subjects who have not experienced a Complete Response with no residual detectable
disease after Part A will continue on to Part B.
- A maximum of 6 cycles of 28 days. Ofatumumab will be given intravenously on day 1 and
Alemtuzumab will be given as a subcutaneous (under the skin) injection on days 1, 3, 5,
8, 10, 12, 15, 17, 19, 22, 24 and 26.
Part C - Maintenance with Ofatumumab + Alemtuzumab
- Subjects who have experienced at least stable disease in Parts A and B can continue on
to Part C. Subjects who are eligible may instead proceed to stem cell transplantation
after Parts A and B.
- Part C is a maximum of 26 cycles of 28 days. Ofatumumab will be given intravenously
every other cycle. Alemtuzumab will be given as a subcutaneous injection every 14
During all cycles subjects will also have clinical exams, and blood tests; imaging tests (CT
scans), bone marrow aspirate and biopsy, and serum pregnancy tests (if applicable) will
occur at various intervals.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
To determine the ORR at the conclusion of two-part induction therapy with ofatumumab-HDMP (Part A) followed by ofatumumab-alemtuzumab (Part B) in two cohorts of participants with 17p deletion: previously untreated, or relapsed/refractory.
Jennifer R Brown, MD PhD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|