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

Phase 2
18 Years
Open (Enrolling)

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Trial Information

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.

Inclusion Criteria:

- Documented CLL/SLL

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (ORR)

Outcome Description:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Jennifer R Brown, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

Related Keywords:

  • CLL
  • SLL
  • 17p Deletion CLL



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115