Study on Inotuzumab Ozogamicin and Chemotherapy for Young Adults with Newly Diagnosed B Acute Lymphoblastic Leukemia
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT03150693
This clinical trial is exploring the effects of adding inotuzumab ozogamicin to standard chemotherapy for young adults newly diagnosed with B acute lymphoblastic leukemia. The study aims to determine if this combination can improve treatment outcomes and survival rates.
Patient Parameters
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Program Overview
This study is testing whether adding inotuzumab ozogamicin, a monoclonal antibody, to standard chemotherapy can help treat young adults with newly diagnosed B acute lymphoblastic leukemia (ALL). Monoclonal antibodies like inotuzumab ozogamicin target specific cancer cells, while chemotherapy drugs work to stop cancer cells from growing and spreading. The trial will assess the safety and effectiveness of this combination treatment.
Description
The main goal of this study is to see if adding inotuzumab ozogamicin to a pediatric-inspired chemotherapy regimen can improve the chances of staying cancer-free for young adults with B acute lymphoblastic leukemia. Researchers will also look at how this combination affects overall survival and the presence of minimal residual disease (MRD), which is a small number of cancer cells that might remain after treatment.
Participants will first receive a series of treatments to induce remission, which includes various chemotherapy drugs. Those who respond well will be randomly assigned to one of two groups. One group will continue with standard chemotherapy, while the other group will receive inotuzumab ozogamicin along with chemotherapy.
The study will also explore genetic factors that might influence treatment outcomes and side effects. Participants will be monitored closely for any side effects and their response to the treatment over several years.
After completing the study treatment, participants will have regular follow-up visits to monitor their health and check for any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed with CD-22 positive B-cell acute lymphoblastic leukemia (ALL).
- No prior treatment for ALL, except for limited use of corticosteroids or hydroxyurea.
- Not pregnant or nursing, with a negative pregnancy test required for women of childbearing potential.
- Good overall health with an ECOG performance status of 0-2.
- Adequate liver and kidney function as indicated by specific blood tests.
- Completion of initial remission induction therapy with a certain level of response.
- No significant fluid buildup in the body or severe swelling.
- Sufficient blood cell counts, including neutrophils and platelets.
- Willingness to use a medication monitoring system during the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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