Ofatumumab-based Induction Chemoimmunotherapy in Previously Untreated Patients With CLL/SLL

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jun 15, 2010

Keywords

ClinConnect Summary

OUTLINE:

Patients with adverse interphase cytogenetics (11q22 or 17p13 deletion) receive FCO induction therapy:

* Ofatumumab is given IV on day 1 (300 mg) and day 8 (1000 mg) of course 1 and on day 1 (1000 mg) of all subsequent courses.
* Fludarabine phosphate (25mg/m2/d) and cyclophosphamide (250mg/m2/d) are given IV on days 2 through 4 of course 1 and on days 1 through 3 of all subsequent courses. Patients age 70 or older will be given reduced doses of fludarabine (20mg/m2/d) and cyclophosphamide (150mg/m2/d).
* Treatment repeats every 28 days for up to 6 courses in the absence of disea...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• Histologically confirmed CLL or SLL as defined by the following:
• • B-lymphocytosis greater than 5000 cells/micro L (may be less than 5000 cells/micro L if lymphadenopathy is present with histologic confirmation of lymph node involvement by SLL).
• • Immunophenotypic profile consistent with CLL as demonstrated by flow cytometry
• • Appropriate immunophonotype (CD5/19/23+)
• • Clonality of lymphocytosis confirmed by flow cytometry
• • large lymphocytes less than 55 % of blood lymphocytes
• Active disease as defined by at least one of the following:
• • Weight loss greater than or equal to10 percent within the previous 6 months
• • Extreme fatigue
• • Fevers of greater than 100.5 degree F for greater than or equal to 2 weeks without evidence of infection
• • Night sweats for more than one month without evidence of infection
• • Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia
• • Massive or progressive splenomegaly
• • Massive nodes or clusters or progressive lymphadenopathy
• • Progressive lymphocytosis with an increase of greater than 50% over a 2 month period, or an anticipated doubling time of less than 6 months 0
• • Measurable disease (defined as two dimensional disease on imaging or quantifiable leukemic disease).
• • Ages 18 and over.
• EXCLUSION CRITERIA:
• • Prior monoclonal antibody therapy with agents having anti-CLL activity
• • Prior cytotoxic chemotherapy with agents having anti-CLL activity (Fludarabine, Cyclophosphamide, Bendamustine, Chlorambucil)
• • Transformed CLL
• • Active autoimmune hemolytic anemia or thrombocytopenia
• • Any medical condition that requires the chronic use of corticosteroids
• • Active or latent Hepatitis B infection
• • HIV infection
• • Severe chronic obstructive pulmonary disease, severe cardiac disease, or other uncontrolled medical condition that would, in the opinion of the principal investigator, place the subject at an unreasonable risk of life-threatening adverse events due to chemoimmunotherapy
• • ECOG performance status 3 or worse
• • Creatinine greater than or equal to 2 mg/dL or creatinine clearance less than or equal to 30 mL/min
• • Bilirubin greater than or equal to 2 mg/dL or active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment)
• • Female patients: Current pregnancy or unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential or currently breastfeeding. Male patients who are unwilling to follow the contraception requirements described in this protocol.
• • Psychiatric illness/social situations that would limit the patient s ability to tolerate and/or comply with study requirements.
• • Unable to understand the investigational nature of the study or give informed consent.