A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

• Status: Recruiting
• Trial end date: 2024-04-08
• Target enrollment: 0
• Participant gender: All

Summary

The study aims to evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL) and to determine the maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC administered blinatumomab.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Blinatumomab

Criteria

Inclusion Criteria:

• Aged 18 years or older.

• Participants with B-precursor ALL with Relapsed or Refractory disease with any of the following:

• Refractory to primary induction therapy or refractory to salvage therapy

• In untreated first, second, third or greater relapse or refractory relapse

• First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuation therapy

• Primary Refractory disease is defined as the absence of CR after standard induction therapy

• Refractory relapse is defined as lack of CR after salvage treatment

• Second relapse or later relapse is defined

• Relapsed or Refractory at any time after first salvage therapy or refractory relapse.

• Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT).

• Greater than or equal to 5% blasts in the Bone Marrow.

• Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2.

• Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible.

• Participants with CR2 or greater with a BM blast count of at least 0.1% (10-3).

The above is a summary, other inclusion criteria details may apply.

Exclusion Criteria:

• Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and or clinical signs of CNS leukemia.

• History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis.

• Symptoms and/or signs that indicate an acute or uncontrolled chronic infection.

• History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy.

• Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy.

• Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy.

• Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of protocol therapy.

• Currently receiving treatment in, or less than 30 days since ending treatment on another investigational study(ies).

• Abnormal screening laboratory parameters

• Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment.

The above is a summary, other exclusion criteria details may apply.