Trial · NCT04264806
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 Transplantation (HSCT)
NCT04264806, Phase 2, Withdrawn, Janssen Research & Development, LLC
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. 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 Transplantation (HSCT). Trials, record NCT04264806. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04264806
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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 Transplantation (HSCT)
- NCT number
- NCT04264806
- Status
- Withdrawn
- Phases
- Phase 2
- Enrollment
- 0 participants, actual
- Lead sponsor
- Janssen Research & Development, LLC
- Conditions
- Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
- Interventions
- Azacitidine, Cusatuzumab
- First posted
- 2020-02-11
- Last updated
- 2022-05-20
- Other registries' IDs
- eudract:2019-003576-40
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | Up to 4 years | ORR is a composite of complete remission (CR), partial remission (PR) and marrow complete remission (mCR) as per modified International Working Group (IWG) criteria. |
| Secondary | Percentage of Participants Achieving Complete Remission (CR) | Up to 4 years | Percentage of participants achieving CR as per IWG criteria will be reported. |
| Secondary | Percentage of Participants who Achieve Transfusion Independence | Up to 4 years | Percentage of participants who achieve transfusion independence will be reported. Transfusion independence is defined as a period of greater than or equal to (\>=) 56 consecutive days with no transfusion occurring between the first and last dose of study drug +30 days. |
| Secondary | Time to Transformation of Participants to Acute Myeloid Leukemia (AML) | Up to 4 years | Time to transformation of participants to AML will be reported. Transformation to AML is defined as \>= 20% bone marrow blasts. |
| Secondary | Progression Free Survival (PFS) | Up to 4 years | PFS is defined as the time from randomization to disease progression; relapse from CR, PR, or mCR; or death from any cause. |
| Secondary | Overall Survival (OS) | Up to 4 years | OS is defined as the time from randomization to death. |
| Secondary | Hematologic Improvement Rate | Up to 4 years | Hematologic improvement rate is defined as erythroid response (pretreatment, less than (\<) 11 g/dL; hemoglobin \>= 1.5 g/dL; relevant reduction of units of RBC transfusions by an absolute number of \>= 4 Red blood cell (RBC) transfusions/8 weeks compared with the pretreatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a hemoglobin of \<= 9.0 g/dL pretreatment will count in the RBC transfusion response evaluation; platelet response (pretreatment \<100\*10\^9/L); absolute increase of \>= 30\*109/L for participants starting with \>20\*10\^9/L platelets; increase to \>20\*109/L and by \>= 100% for participants starting with \<= 20\*109/L platelets; Neutrophil response (pretreatment \<1.0×10\^9/L); and at least 100% increase and an absolute increase of \>0.5\*10\^9/L. |
| Secondary | Percentage of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability | Up to 4 years | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. |
| Secondary | Percentage of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to 4 years | Percentage of participants with clinically significant abnormalities in laboratory parameters will be reported. |
| Secondary | Area Under the Serum Concentration-Time Curve Within Timespan t1 to t2 (AUC[t1-t2]) of Cusatuzumab | Cycle 1: Day 3,17 (predose, end of infusion [EOI] postdose), Day 4 (24 hours postdose) Cycle 2, 3, 4, 8, 11: Day 3 (predose, EOI postdose); Cycle 4 Day 21 to Cycle 5: Day 1(at disease evaluation); and end of treatment (EOT) [up to 4 years]) | The AUC(t1-t2) is the area under the serum concentration-time curve within timespan t1 to t2. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04264806
GET https://conductscience.org/api/trials/v1/NCT04264806/registered