At a glance
ClinicalIndex Comparison Record- ✓Newly diagnosed, previously untreated B-lineage ALL or lymphoblastic lymphoma, or CR after one induction course
- ✓Failure to one induction course of chemotherapy (analyzed separately)
- ✓Allowed use of steroids, ara-c, or hydrea prior to treatment plan finalization
- ✓No active or co-existing malignancy with life expectancy less than 12 months
- ✕Pregnant or nursing women
- ✕HIV-positive
- ✕Philadelphia chromosome-positive ALL
- ✕Active and uncontrolled disease/infection
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia
In Brief
A Phase 2 clinical trial evaluating Blinatumomab, Cyclophosphamide, and 11 other interventions for B Acute Lymphoblastic Leukemia and B Lymphoblastic Lymphoma. Currently recruiting, targeting 80 participants across 1 site.
Detailed Summary
This phase II trial studies how well blinatumomab, inotuzumab ozogamicin, and combination chemotherapy work as frontline therapy in treating patients with B acute lymphoblastic leukemia. Immunotherapy with monoclonal antibodies, such as blinatumomab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a toxic agent called ozogamicin. Inotuzumab attaches to CD22 positive cancer cells in a targeted way and delivers ozogamicin to kill them. Drugs used in chemotherapy, such as cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride, dexamethasone, cytarabine, mercaptopurine, methotrexate, and prednisone 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. Giving blinatumomab, inotuzumab ozogamicin, and combination chemotherapy may work better in treating patients with B acute lymphoblastic leukemia than chemotherapy alone.
Study Details
Timeline
Interventions
Given IV
Given IV
Given IT and IV
Given PO
Given IV
Given IV
Correlative studies
Given PO
Given IT, IV, and PO
Given IV
Given PO
Given IV
Given IV