Inotuzumab Ozogamicin and Chemotherapy for Acute Lymphoblastic Leukemia
This study is testing inotuzumab ozogamicin, a targeted immunotherapy, combined with standard chemotherapy drugs like cyclophosphamide and cytarabine, for patients with acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin works by attaching to cancer cells and delivering a toxic agent to kill them. Another immunotherapy, blinatumomab, is also being used to help your body's immune system fight the cancer. The study aims to find the safest dose of inotuzumab ozogamicin and see how well this combination treatment works, especially in older patients (60 years or older) with newly diagnosed ALL, or those with ALL that has returned or not responded to previous treatments. Success will be measured by how long patients live without their cancer getting worse and how many patients respond to the treatment. This study is currently unclear regarding its recruitment status.
- Study design
- This is a Phase I/II study, meaning it first looks for the best dose and then evaluates how well the treatment works. It plans to enroll 276 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will follow participants for up to 2 years to measure progression-free survival and up to 5 years to measure response rate.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Inotuzumab Ozogamicin and Combination Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Elias Jabbour, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Maximum tolerated dose of inotuzumab ozogamicin based on incidence of dose limiting toxicities (Phase I)28 days
Defined as non-hematologic grade 3 or 4 toxicities during the first course. Toxicities will be monitored using the method of Thall, Simon, and Estey. Adverse events will be summarized and toxicity rate will be estimated with a 90% credible interval.
- Progression free survival (PFS) in frontline elderly acute lymphoblastic leukemia (ALL) (Phase II)2 years
Bayesian time-to-event model will be used. Kaplan and Meier product limit method will be used to estimate the PFS along with the 95% confidence intervals for the median PFS. Univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors.
- Response rate in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)Up to 5 years
The precise complete remission (CR) and marrow CR rate will be defined.
- Survival in refractory-relapsed acute lymphoblastic leukemia (ALL) (Phase II)Up to 1 year
The median and 1-year survival rate will be defined. Kaplan and Meier product limit method will be used to estimate the overall survival (OS) along with the 95% confidence intervals for the median OS. Univariate and multivariate Cox proportional hazards regression models will be used to identify prognostic factors.