A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With F… (NCT04546399) | Clinical Trial Compass
RecruitingPhase 2
A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
United States, Australia, Canada461 participantsStarted 2020-12-17
Plain-language summary
This phase II trial studies the effect of nivolumab in combination with blinatumomab compared to blinatumomab alone in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) that has come back (relapsed). Down syndrome patients with relapsed B-ALL are included in this study. Blinatumomab is an antibody, which is a protein that identifies and targets specific molecules in the body. Blinatumomab searches for and attaches itself to the cancer cell. Once attached, an immune response occurs which may kill the cancer cell. Nivolumab is a medicine that may boost a patient's immune system. Giving nivolumab in combination with blinatumomab may cause the cancer to stop growing for a period of time, and for some patients, it may lessen the symptoms, such as pain, that are caused by the cancer.
Who can participate
Age range
1 Year – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be \>= 1 and \< 31 years at time of enrollment
* Patients must have first relapse of CD19+ B-ALL (relapse blasts must express CD19) in one of the following categories:
* Isolated bone marrow relapse
* Isolated central nervous system (CNS) (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* Combined bone marrow with extramedullary relapse in the CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testes
* Patients with Down syndrome (DS) are eligible in the following categories:
* Isolated bone marrow relapse
* Combined bone marrow with CNS (excluding known optic nerve/retinal and CNS chloromas) and/or testicular relapse
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Of note, for patients with developmental delay (e.g., Down syndrome) regardless of age, Lansky scale may be substituted for Karnofsky scale. However, the requirement for ECOG 0-2 remains, regardless of known history of developmental delay
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Patients with prior blinatumomab or CD19+ chimeric antigen receptor therapy in the upfront setting will be eligible, provided relapsed lymphoblasts retain CD19 ex…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 2 trial comparing blinatumomab alone to blinatumomab combined with nivolumab for first-relapse B-ALL, what is currently known about the safety of adding nivolumab to blinatumomab, and what additional risks might come with the combination that wouldn't exist with blinatumomab alone?
2The trial is measuring whether patients achieve MRD-negative remission — a very deep level of remission with no detectable leukemia — so how does my child's or my current disease burden affect the likelihood of reaching that goal, and how does that compare to what standard reinduction chemotherapy might offer?
3I noticed the trial has separate groups, including one specifically for patients with Down Syndrome — is there a particular group that would apply to my situation, and how does that affect what treatment I'd actually receive and what the study is trying to learn?
4Since this trial is actively recruiting and still in Phase 2, the long-term outcome data isn't fully established yet — given where we are in my treatment, would my doctor recommend trying standard salvage therapy first, or is there a reason to consider this trial at this specific point in my relapse?
5What would the treatment schedule and monitoring visits actually look like for this trial in terms of how often I'd need to come in, how long treatment lasts, and whether this could be managed given my current living situation and support system?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Minimal residual disease (MRD) negative second remission (Rem-2) rate with blinatumomab vs with blinatumomab + nivolumab (Group 1)
Timeframe: Up to 2 cycles of therapy (each cycle = 36 days)
Timeframe: From date of randomization to date of treatment failure, relapse, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment.
3
EFS PR (Group 4)
Timeframe: From date of randomization to date of treatment failure, relapse, second malignancy (SMN) or death due to any cause, assessed up to 10 years after completion of enrollment.