Immunogen IMGN632-0802
Research type
Research Study
Full title
A Phase 1b/2 Study of IMGN632 as Monotherapy or Combination with Venetoclax and/or Azacitidine for Patients with CD123-Positive Acute Myeloid Leukemia
IRAS ID
278333
Contact name
Anna Berkenblit
Contact email
Sponsor organisation
ImmunoGen, Inc.
Eudract number
2019-002477-56
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 29 days
Research summary
AML is the most common form of acute leukemia among adults, accounting for the largest number of deaths. Frontline chemotherapy in AML induces complete response (CR) in ~ 70% of patients who are 60 years of age or younger, and approximately 50% of older patients.
Despite being in CR, these patients often have minimal residual disease (MRD). The presence of even low amounts of AML after completion of standard treatment predicts relapse and poor survival. There is no standard of care treatment for these patients; therefore, novel therapies may provide benefit.
AML patients are most often assessed to be in 2 categories, namely “Fit” and “Unfit”. “Fit” patients are judged to tolerate intensive treatment, are often younger and post-induction therapies result in potential cures in around 40% of the patients. Unfit” patients, often older or with comorbidities, typically receive non-intensive treatments, such as azacitidine. With this treatment, approximately 30% will achieve a CR, with a median overall survival of ~ 10 months.
Recently, a venetoclax combination with azacitidine has demonstrated promising efficacy in relapsed and frontline populations. Despite these therapies, most patients with AML will eventually relapse. Thus, combinations with venetoclax and/or azacitidine represent appropriate and promising opportunities for patients with relapsed or frontline unfit AML.
This study will investigate if IMGN632 (Investigational Drug) is an effective treatment for patients with frontline or relapsed “unfit” AML and Frontline “fit” patients who are MRD positive, when used in combination with Venetoclax and/or Azacitidine.
Additionally, we will test safety and tolerability of IMGN632, how it is broken down by the body and its effects on the body of subjects through blood tests. The study will recruit 140 patients with AML, from 33 hospitals around the world, with 2 of these in the UK, the study will last around 2 years.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0058
Date of REC Opinion
31 Mar 2020
REC opinion
Further Information Favourable Opinion