CASCADE
Research type
Research Study
Full title
A randomized, double-blind phase 3 study of vadastuximab talirine (SGN-CD33A) versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)
IRAS ID
200168
Contact name
Eduardo Olavarria
Contact email
Sponsor organisation
Seattle Genetics, Inc.
Eudract number
2015-003482-28
Clinicaltrials.gov Identifier
116300, IND number
Duration of Study in the UK
4 years, 7 months, 12 days
Research summary
Acute leukaemia is a malignant disease of the hemopoietic stem cell that typically develops in the bone marrow before spreading to the peripheral blood. Acute myeloid leukaemia (AML) is one of the most common types of leukaemia in adults. AML is a fast growing disease and if left untreated will be fatal.
This clinical study will evaluate how effective and safe the study medication vadastuximab talirine is when combined with decitabine or azacitidine in elderly patients with AML who have not received treatment for their AML yet.The classical treatment of AML aims to quickly reduce the amount of leukaemia cells, which is called remission induction therapy and is usually reserved for younger AML patients. Yet for elderly AML patients, this therapy approach is often inappropriate due to disease factors that cause resistance to the treatment, or because they are suffering from additional medical conditions that, if undergoing this treatment, would lead to serious side effects.
AML is associated with very poor survival rates in patients with advanced age. Current standard of care with either azacitidine or decitabine is improving overall survival in elderly AML patients. However, the outcomes with either of these therapies remain suboptimal.Potential participants will undergo eligibility screening prior to enrolling on the study. Treatment with vadastuximab talirine or placebo (a dummy medication) will be combined with either azacitidine or decitabine. Participants may continue on study treatment until disease progression, initial improvement and then return of the AML, or unacceptable side effects occur. After finishing their treatment, participants will be followed for safety for about 30 days. Long term follow-up will occur until progression or AML recurrence every 2 months for 2 years and every 4 months thereafter until initiation of another anticancer treatment, progression or leukemic relapse.
Approximately 500 participants aged 65 years or older will be enrolled on the study.REC name
East of England - Essex Research Ethics Committee
REC reference
16/EE/0195
Date of REC Opinion
23 Jun 2016
REC opinion
Further Information Favourable Opinion