74494550MDS2001
Research type
Research Study
Full title
A Phase 2, Randomized, Open-label Study of Cusatuzumab in Combination with Azacitidine Compared with Azacitidine Alone in Patients with Higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) and who are not candidates for Hematopoietic Stem Cell Transplantation (HSCT)
IRAS ID
276741
Contact name
Austin Kulasekararaj
Contact email
Sponsor organisation
Janssen-Cilag International N.V.
Eudract number
2019-003576-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Response rates for patients with Higher-Risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) treated with azacitidine (a standard treatment) vary considerably depending on the specific patient population, whether azacitidine is administered alone or in combination with another medication, and how overall response rate (ORR) is defined. Hematopoietic stem cell transplantation (HSCT) is the only therapeutic approach with known curative potential for patients diagnosed with MDS or CMML who have higher-risk disease, but many patients are unable to undergo HSCT due to the potential side-effects or complications caused by other conditions (comorbidities).
The purpose of this study is to see if cusatuzumab when combined with azacitidine is safe and more effective than azacitidine alone for treating patients with higher-risk MDS or CMML who are not candidates to receive a stem cell transplant.
Participants will be randomly assigned (randomised) equally to one of two groups, and will then receive either azacitidine alone or azacitidine and cusatuzumab in combination as a study treatment. This study consists of a Screening phase, a Treatment phase (with 28-day treatment cycles) and a Follow-up phase. The Follow-up Phase will begin once a participant discontinues study treatment and will continue until either death, the participant becomes lost to follow-up, or the study ends, whichever occurs first.
REC name
London - Brent Research Ethics Committee
REC reference
20/LO/0363
Date of REC Opinion
14 May 2020
REC opinion
Further Information Favourable Opinion