Phase II Study of the Hyper - CVAD Regimen in Combination with Ofatumumab as Frontline Therapy for patients with CD-20 positive Acute Lymphoblastic Leukemia
The goal of this clinical research study is to learn if ofatumumab combined with standard chemotherapy can help to control ALL. The safety of these drug combinations will also be studied.
Disease Group: Leukemia
Treatment Agent: Cytarabine
Treatment Location: Only at MDACC
Sponsor: Novartis Pharmaceuticals
Primary Objectives: To evaluate the clinical efficacy of the combination of hyper-CVAD + ofatumumab in patients with newly diagnosed acute lymphoblastic leukemia with any level of CD20 expression: - Event-free survival - Overall response rate - Overall survival Secondary Objectives: To evaluate the safety of this combination.
IRB Review and Approval Date: 07/12/2011
Recruitment Status: Closed
Projected Accrual: N/A
1) Patients of all ages with newly diagnosed, previously untreated
CD-20+ ALL, or lymphoblastic lymphoma, Burkitt Leukemia/Lymphoma or
having achieved CR with one course of induction chemotherapy.
2) Failure to one induction course of chemotherapy (these patients will be analyzed separately).
3) Performance status of 0, 1, or 2.
4) Adequate organ function with creatinine less than or equal to 3.0 mg/dL (unless considered tumor related), bilirubin less than or equal to 3.0 mg/dL (unless considered tumor related).
5) Adequate cardiac function defined as no clinically significant history of arrhythmia as determined by the PI and/or the treating physician, history of MI or clinically significant abnormal EKG, as determined by the PI and/or the treating physician, within 3 months prior to study enrollment. Cardiac function will be assessed by history and physical examination.
6) No active or co-existing malignancy(other than ALL or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy.
1) Pregnant or nursing women.
2) Known to be HIV+
3) Ph+ ALL
4) Active and uncontrolled disease/infection as judged by the treating physician
5) Unable or unwilling to sign the consent form
6) 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)
7) Treatment with any known non – marketed drug substance or experimental therapy within 5 terminal half lives (calculated by multiplying the reported terminal half life by 5) or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study.
8) History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
9) Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. Consult with a physician experienced in care & management of subjects with hepatitis B to manage/treat subjects who are anti-HBc positive.
10) Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result