Using inotuzumab ozogamicin to treat B-cell acute lymphoblastic leukemia with minimal residual disease
Phase II Study of Inotuzumab Ozogamicin in Patients With B-Cell Lineage Acute Lymphocytic Leukemia With Positive Minimal Residual Disease
This study is testing a new treatment called inotuzumab ozogamicin for people with B-cell acute lymphoblastic leukemia who are in remission but still have some cancer cells left, to see if it helps them stay cancer-free longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | inotuzumab, chemotherapy, methotrexate |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03441061 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of inotuzumab ozogamicin in treating patients with B-cell acute lymphoblastic leukemia (ALL) who are in complete remission but have positive minimal residual disease (MRD). The treatment involves administering inotuzumab ozogamicin intravenously over one hour on specific days, repeating every 21-28 days for up to six cycles, depending on the patient's response and tolerance. The primary goal is to evaluate relapse-free survival, while secondary objectives include assessing overall survival and the rate of achieving MRD negativity. Patients will be monitored for safety and efficacy throughout the treatment period.
Who should consider this trial
Good fit: Ideal candidates include patients with B-cell acute lymphoblastic leukemia in complete remission but with detectable minimal residual disease.
Not a fit: Patients who are not in complete remission or those with other types of leukemia may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve relapse-free survival rates for patients with B-cell acute lymphoblastic leukemia who have minimal residual disease.
How similar studies have performed: Other studies have shown promising results with similar targeted therapies in treating acute lymphoblastic leukemia, indicating a potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with B-lineage ALL in hematologic complete remission (CR) with molecular failure (ie, had never achieved an MRD-negativity status before inotuzumab ozogamicin) or had a molecular relapse (ie, became MRD positive after having been MRD negative) starting at any time point after 3 months of frontline therapy. Molecular disease or minimal residual disease is defined by any level of measurable residual disease identified by multicolor flow cytometry, PCR and/or next-generation sequencing (NGS). * Patients with B-lineage ALL in at least marrow CR in salvage 1 and beyond with MRD failure at any time point after 1 month of salvage therapy are allowed, including patients who received prior allogeneic stem cell transplantation. * Patients with Ph+ ALL can be enrolled in CR1 or CR2 and beyond. A TKI will be added at the discretion of the treating physician. MRD for these patients will be defined by either 1.) a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% according to the International Scale for patients with p210 transcript or a ratio of BCR-ABL1 to ABL1 by PCR of ≥ 0.01% for patients with non-p210 transcripts, or 2.) detectable MRD at any level of measurable residual disease identified by multicolor flow cytometry and/or by NGS. * Performance status of 0, 1, or 2 * Creatinine clearance \>= 15 ml/min * Bilirubin \< 1.5 X upper limit of normal (ULN) * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \< 3 X ULN * No active or co-existing malignancy with life expectancy less than 12 months Exclusion Criteria: * Pregnant or nursing women * Known to be human immunodeficiency virus positive (HIV+) * Active and uncontrolled disease/infection as judged by the treating physician * Unable or unwilling to sign the consent form * Active central nervous system (CNS) or extramedullary disease * Monoclonal antibodies therapy within 2 weeks before study entry * Radiotherapy or cancer chemotherapy (except for intrathecal prophylaxis and/or low-dose maintenance therapy such as vinca alkaloids, mercaptopurine, methotrexate, steroids) or any investigational drug within 2 weeks before study entry
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Elias Jabbour — M.D. Anderson Cancer Center
- Study coordinator: Elias Jabbour, MD
- Email: ejabbour@mdanderson.org
- Phone: 713-792-4764
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.