Introducing Helene Relief: A Randomized Phase II Study for Patients with Newly-Diagnosed Relapsed or Refractory High Risk Acute Lymphoblastic Leukemia
Study Overview
Helene Relief is a randomized phase II study for patients with high-risk acute lymphoblastic leukemia (ALL) who have achieved a complete response (CR) or better after frontline induction chemotherapy. Patients will be randomized to receive either blinatumomab or inotuzumab ozogamicin in combination with high-dose cytarabine and mitoxantrone.
Objectives
The primary objective of Helene Relief is to evaluate event-free survival (EFS) in patients randomized to blinatumomab or inotuzumab ozogamicin. Secondary objectives include:
- Overall survival (OS)
- Minimal residual disease (MRD) negativity rates
- Safety and tolerability
Background
ALL is the most common type of cancer in children and the second most common in adults. The overall survival rate for ALL has improved significantly in recent years, but patients with high-risk ALL have a poor prognosis. Blinatumomab and inotuzumab ozogamicin are two newer agents that have shown promising results in patients with relapsed or refractory ALL.
Blinatumomab is a bispecific antibody that targets CD19, a protein that is expressed on the surface of ALL cells. Inotuzumab ozogamicin is a monoclonal antibody that targets CD22, another protein that is expressed on ALL cells.
Study Design
Helene Relief is a phase II, randomized, open-label trial. Patients will be enrolled at approximately 25 sites in the United States. The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.
Patients who are eligible for the study must be between the ages of 18 and 65 years and have high-risk ALL. High-risk ALL is defined as having one or more of the following features:
- Philadelphia chromosome-positive ALL
- MLL-rearranged ALL
- BCR-ABL1-positive ALL
- Hypodiploidy
- Induction failure
- Early relapse (<12 months)
Patients will be randomized to receive either blinatumomab or inotuzumab ozogamicin in combination with high-dose cytarabine and mitoxantrone. The treatment regimen is as follows:
- Blinatumomab: 15 mg/m2/day for 28 days, followed by 28 days of rest
- Inotuzumab ozogamicin: 0.8 mg/kg on days 1, 8, and 15
- High-dose cytarabine: 2 g/m2/day for 5 days
- Mitoxantrone: 10 mg/m2/day for 3 days
Patients will be followed for a minimum of 2 years after the completion of treatment. The primary endpoint of the study is EFS. Secondary endpoints include OS, MRD negativity rates, and safety and tolerability.
Significance
Helene Relief is a pivotal study that could lead to the approval of blinatumomab or inotuzumab ozogamicin for the treatment of patients with high-risk ALL. The study is also expected to provide important information about the safety and efficacy of these two agents.
