Status:
COMPLETED
Ofatumumab and High-dose Methylprednisolone in Patients With Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
Januario Castro, M.D.
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
CLL
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. ...
Detailed Description
Patients who have relapsed/refractory CLL and require therapy as per iwCLL guidelines will be eligible. Subjects will receive a treatment with ofatumumab and HDMP for three consecutive 4 week cycles. ...
Eligibility Criteria
Inclusion
- Previously treated patients with a diagnosis of CLL
- Previous treatment with any monoclonal antibody or chemotherapy regardless of response as defined by the iwCLL Working Group Guidelines as evidenced by:
- progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
- massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
- massive nodes (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy.
- progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months.
- autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy (See Section 10.2)
- Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs: unintentional weight loss of 10% or more within the previous 6 months significant fatigue (i.e. ECOG PS 2 or worse, inability to work or perform usual activities), fevers higher than 100.5ºF or 38.0ºC for 2 or more weeks without other evidence of infection, night sweats for more than 1 month without evidence of infection
- Subjects must be 18 years of age or older, male or female.
- ECOG performance status of 0-2.
- Subjects must be able to give informed consent.
- Females of child bearing potential(FCBP)† must have a negative serum or urine pregnancy test within 10 - 14 days prior to and again within 24 hours of starting treatment and agree to use a medically accepted contraceptive method for the duration of this study.
Exclusion
- Hepatitis BsAg positive, Hepatitis BcAb positive, and Hepatitis C positive patients.
- Known HIV positive patients.
- Diabetics.
- Patients with uncontrolled Autoimmune Hemolytic Anemia (AIHA) or autoimmune thrombocytopenia (ITP).
- Screening laboratory values within these ranges: platelets \<50 x 109/L, neutrophils \<1.0 x 109/L, creatinine \>2.0 times upper normal limit,total bilirubin \>1.5 times upper normal limit (unless a known history of Gilbert's disease), ALT \>2.5 times upper normal limit (unless due to disease involvement of liver), alkaline phosphatase \>2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow)
- Inability to provide informed consent.
- Concurrent malignancy (excluding basal and squamous cell skin cancers).
- Active fungal, bacterial, and/or viral infection.
- History of peptic ulcer disease resulting in GI bleeding within the last 6 months.
- Untreated metabolic disorders such as hypothyroidism and Cushing's disease.
- History of steroid-induced psychosis.
- Estimated life expectancy of less than 3 months by the investigator's best clinical judgment.
- Serious medical condition that would render the subject medically unstable.
- Women who are pregnant or breast-feeding.
- History of Pancreatitis.
- History of Diverticulitis.
- Patients with known hypersensitivity to ofatumumab or known history of anaphylaxis to Rituximab or alemtuzumab.
- Concurrent use of other anti-cancer agents or treatments.
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01191190
Start Date
August 1 2010
End Date
August 1 2012
Last Update
May 8 2018
Active Locations (2)
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1
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92093
2
University of California San Diego, Moores Cancer Center
La Jolla, California, United States, 92093