Combination Chemotherapy and Ofatumumab in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
NCT01363128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72
Last updated 2021-05-03
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.
Conditions
- 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
Interventions
- DRUG
-
Given IV
- DRUG
-
Given IV
- DRUG
-
Given IV or PO
- DRUG
-
Doxorubicin Hydrochloride
Given IV
- OTHER
-
Laboratory Biomarker Analysis
Correlative studies
- DRUG
-
Methotrexate
Given IV
- BIOLOGICAL
-
Ofatumumab
Given IV
- DRUG
-
Vincristine Sulfate
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Elias Jabbour · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-12
- Primary Completion
- 2020-04-08
- Completion
- 2020-04-08
- FDA Drug
- Yes
Countries
- United States
Study Locations
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