Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagn
This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different wa
| Condition(s) | B Acute Lymphoblastic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia. |
| Who can participate | Inclusion Criteria: REGISTRATION ELIGIBILITY CRITERIA (STEP 1) * Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible * Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: flow cytometry is to be performed at the local reference lab and must include assessment of CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity * No prior therapy except for limited treatment (\< 7 days) with corticosteroids or hydroxyurea and a singl |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Lead sponsor | Alliance for Clinical Trials in Oncology |
| Locations | Birmingham, Alabama, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States; Anchorage, Alaska, United States (+454 more sites) |
| Start date | 2017-09-20 |
| NCT ID | NCT03150693 |
| Official listing | https://clinicaltrials.gov/study/NCT03150693 |