Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2023
• Main ID: NCT03011034
• Date of registration: 04/01/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
• Scientific title: A Phase 2 Proof-of-Concept Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
• Date of first enrolment: February 14, 2017
• Target sample size: 34
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03011034
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Belgium, France, Italy, Netherlands, Russian Federation, Spain, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria
confirmed by bone marrow aspirate and biopsy within 12 weeks prior to first dose. A
local laboratory report from this diagnostic bone marrow aspirate and biopsy must be
approved by the sponsor

- International Prognostic Scoring System (IPSS) low risk or intermediate-1 risk MDS

- Red blood cell (RBC) transfusion dependent, 1) Received at least 4 units of RBCs over
any 8 consecutive weeks during the 16 weeks prior to randomization, 2) Pretransfusion
Hb must have been less than or equal to (<=)9.0 gram per deciliter (g/dL)

- Adequate iron stores, defined as transferrin saturation greater than 20 percent (%)
and serum ferritin greater than 400 nanogram per Milliliter (ng/mL), measured within
the screening period, or adequate iron stores as demonstrated by recent (within 12
weeks prior to first dose) bone marrow examination with iron stain

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

Exclusion Criteria:

- Known allergies, hypersensitivity, or intolerance to talacotuzumab and daratumumab or
their excipients

- Received any chemotherapy, immunomodulatory or immunosuppressive therapy,
corticosteroids (greater than [>]30 milligram per day [mg/day] prednisone or
equivalent) within 28 days prior to randomization

- Received other treatments for MDS within 28 days prior to first dose (example [eg],
azacitidine, decitabine, lenalidomide, Erythropoiesis-Stimulating Agent (ESA) (8 weeks
for long-acting ESAs)

- History of hematopoietic stem cell transplant

- Del(5q) karyotype unless treatment with lenalidomide has failed. Failure is defined as
either: 1) having received at least 3 months of lenalidomide treatment without RBC
transfusion benefit (International Working Group [IWG] 2006); 2) progression or
relapse after hematologic improvement with lenalidomide (IWG 2006); 3) discontinuation
of lenalidomide due to toxicity; or 4) unable to receive lenalidomide due to a
contraindication. Source documentation for lenalidomide treatment failure must be
verified by the sponsor



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndromes

Intervention(s)

Drug: Daratumumab

Drug: Talacotuzumab

Primary Outcome(s)

Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 8 Weeks [Time Frame: Up to 2 years]

Secondary Outcome(s)

Overall Survival [Time Frame: Up to 2 years]

Percentage of Participants With Complete Remission (CR) and Marrow CR [Time Frame: Up to 2 years]

Percentage of Participants With at Least One Dose of Myeloid Growth Factors Usage [Time Frame: Up to 2 years]

Percentage of Participants With Hematologic Improvement (HI) Per IWG 2006 by Investigator Assessment [Time Frame: Up to 2 years]

Percentage of Participants With Partial Remission (PR) [Time Frame: Up to 2 years]

Duration of Transfusion Independence (TI) [Time Frame: Up to 2 years]

Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence (TI) Lasting at Least 24 Weeks [Time Frame: Up to 2 years]

Percentage of Participants Who Met IWG Criteria for Transfusion Reduction [Time Frame: Up to 2 years]

Percentage of Participants With Cytogenetic Response [Time Frame: Up to 2 years]

Time to Progression to Acute Myeloid Leukemia (AML) [Time Frame: Up to 2 years]

Time to Transfusion Independence (TI) [Time Frame: Up to 2 years]

Secondary ID(s)

2016-003328-22

56022473MDS2002

CR108261

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03011034