Ofatumumab With High Dose Methylprednisone Followed by Ofatumumab and Alemtuzumab in 17p CLL



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:November 2011
End Date:December 2020

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A Phase II Study of Ofatumumab-High Dose Methylprednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deletion CLL

The main purpose of this study is to examine how two separate groups of 17p deletion Chronic
lymphocytic leukemia (CLL) participants respond to sequential treatment with this particular
combination of drugs. The two groups are those participants who have previously received
treatment for their CLL and those who have not yet received any treatment. The combination of
drugs is Ofatumumab and High-Dose Methylprednisolone (HDMP) first followed by Ofatumumab and
Alemtuzumab. All three drugs are FDA approved and have known activity in treating 17p CLL. We
hope that by combining these drugs together in this study, they will have more benefit than
each one alone and that the subjects' CLL will be significantly impacted.

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 days.

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.

Inclusion Criteria:

- Documented CLL/SLL

- 17p deletion by FISH in 20% or more nuclei on peripheral blood, bone marrow or lymph
node

- Normal organ function

Exclusion Criteria:

- Pregnant or breast feeding

- Current active hepatic or biliary disease

- Chronic or current infectious disease requiring systemic antibiotics, antifungal, or
antiviral treatment such as, but not limited to, chronic renal infection, tuberculosis
and active Hepatitis C

- History of significant cerebrovascular disease in the past 6 months or ongoing event
with active symptoms or sequelae

- Other past or current malignancy. Participants who have been free of malignancy for at
least 2 years, or who have a history of completely resected non-melanoma skin cancer
or successfully treated in situ carcinoma are eligible.

- Known HIV positive

- Clinically significant cardiac disease including unstable angina, acute myocardial
infarction within 6 months prior to study entry, congestive heart failure, and
arrhythmia unless controlled by therapy, with the exception of extra systoles or minor
conduction abnormalities.

- Significant concurrent uncontrolled medical conditions including, but not limited to,
renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or
psychiatric disease which in the opinion of the investigator may represent a risk for
the subject.

- Positive serology for Hepatitis B or C

- History of allergic reactions attributed to ofatumumab.
We found this trial at
2
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Boston, MA
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