Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Completed · Phase 2

Conditions studied: Acute Lymphoblastic Leukemia, Adult Acute Lymphoblastic Leukemia in Complete Remission, Burkitt Leukemia, Burkitt Lymphoma, CD20 Positive, Childhood Acute Lymphoblastic Leukemia in Complete Remission, Lymphoblastic Lymphoma

In brief

This phase II trial studies how well combination chemotherapy and ofatumumab work in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with ofatumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving combination chemotherapy together with ofatumumab may be an effective treatment for acute lymphoblastic leukemia or lymphoblastic lymphoma.

Key facts

Study ID: NCT01363128
Run by: M.D. Anderson Cancer Center
People needed: 72
Starts: 2011-07-12
Expected to finish: 2020-04-08
Last updated by the study team: 2021-05-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients of all ages with newly diagnosed, previously untreated CD-20+ acute lymphoblastic leukemia (ALL), or lymphoblastic lymphoma, Burkitt leukemia/lymphoma or having achieved complete remission (CR) with one course of induction chemotherapy
Failure to one induction course of chemotherapy (these patients will be analyzed separately)
Performance status of 0, 1, or 2
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)
Adequate cardiac function defined as no clinically significant history of arrhythmia as determined by the principal investigator (PI) and/or the treating physician, history of myocardial infarction (MI) or clinically significant abnormal electrocardiogram (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
No active or co-existing malignancy (other than ALL or lymphoblastic lymphoma) with life expectancy less than 12 months due to that malignancy

You may not qualify if…

Pregnant or nursing women
Known to be human immunodeficiency virus positive (HIV+)
Philadelphia chromosome (Ph)+ ALL
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
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)
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
History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
Positive serology for hepatitis B (HB) defined as a positive test for hepatitis B surface antigen (HBsAg); in addition, if negative for HBsAg but hepatitis B core antibody (HBcAb) positive (regardless of HBsAb status), a HB deoxyribonucleic acid (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
Positive serology for hepatitis C (HC) defined as a positive test for hepatitis C antibody (HCAb), in which case reflexively perform a HC radioimmunoblotting assay (RIBA) immunoblot assay on the same sample to confirm the result

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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