Overview

A 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 Trans

Status:
Withdrawn
Trial end date:
2025-01-28
Target enrollment:
0
Participant gender:
All
Summary
The purpose of the study is to compare overall response rate (ORR) between treatment groups in participants with higher-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) who are not eligible for Hematopoietic Stem Cell Transplantation (HSCT).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Janssen Research & Development, LLC
Collaborators:
argenx
argenx BVBA
Treatments:
Azacitidine
Criteria
Inclusion Criteria:

- Diagnosis of de novo or secondary higher-risk Myelodysplastic Syndrome (MDS) or
Chronic Myelomonocytic Leukemia (CMML) per World Health Organization (WHO) 2016
criteria

- At study entry, higher-risk MDS (intermediate, high, and very high risk MDS per
Revised International Prognostic Scoring System [IPSS R]) OR higher-risk CMML
(intermediate-2 or high risk CMML per CMML-specific Prognostic Scoring System
[CPSS-Mol]). Participants with previous lower-risk MDS or CMML that has evolved to
higher-risk MDS or CMML are eligible

- At study entry, not a candidate for Hematopoietic Stem Cell Transplantation (HSCT)

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2

- Adequate liver and renal function defined as follows: Aspartate aminotransferase (AST)
or alanine aminotransferase (ALT) less than (<) 3 * upper limit of normal (ULN); Total
bilirubin less than or equal to (<=) 1.5 * ULN, unless bilirubin rise is due to
Gilbert's syndrome or of non hepatic origin; and Creatinine clearance (CrCl) greater
than (>) 30 milliliter per minute per 1.73 square meters (mL/min/1.73 m^2) (by
Modification of Diet in Renal Disease formula)

Exclusion Criteria:

- Received prior HSCT or any prior treatment, including hypomethylating agent (HMAs),
for higher-risk MDS or CMML. Prior supportive therapies including transfusion and
growth factors are acceptable

- Received prior treatment with cusatuzumab

- Presence of the breakpoint cluster region protein-Abelson murine leukemia (bcr-abl)
rearrangement

- Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug

- Any active systemic infection