Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or… (NCT01363128) | Clinical Trial Compass
CompletedPhase 2
Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
United States72 participantsStarted 2011-07-12
Plain-language summary
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.
Who can participate
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 …
What they're measuring
1
Number of Participants With Complete Remission (CR)