trialsTrialActive

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

A phase 2 trial of Azacitidine and Cusatuzumab in acute myeloid leukaemia, run by OncoVerity, Inc., active and no longer recruiting.

Also called: CULMINATE

A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy is a phase 2 interventional study registered as NCT04023526 by OncoVerity, Inc., with 103 participants enrolled, started 2019-07-29 and due to reach its primary completion in 2023-08-15. Interventions recorded: Azacitidine and Cusatuzumab. Results have been posted on the registry.

Setting

A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

Phase

Phase 2

Sponsor

OncoVerity, Inc.

Registry

Started

2019-07-29

Reported

2024

Enrolled

103 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

103 enrolled

Percentage of Participants With Complete Remission (CR)primarysurrogate endpoint

11.8 vs 26.9 out of 100 had no sign of cancer on scans or tests with Cusatuzumab 10 mg/kg Plus Azacitidine compared with Cusatuzumab 20 mg/kg Plus Azacitidine; 15.2 fewer per 100.
On this measure the first group did worse, not better.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Overall Response Rate (ORR)response endpoint

29.4 vs 40.4 out of 100 had their tumour shrink with Cusatuzumab 10 mg/kg Plus Azacitidine compared with Cusatuzumab 20 mg/kg Plus Azacitidine; 11 fewer per 100.
On this measure the first group did worse, not better.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

103 enrolled.

Percentage of Participants With Complete Remission (CR)primary

Cusatuzumab 10 mg/kg Plus Azacitidine11.76 of 100

n = 51

Cusatuzumab 20 mg/kg Plus Azacitidine26.92 of 100

n = 52

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95% CI 5.5 to 23.4; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication · 95% CI 16.8 to 40.3

Overall Response Rate (ORR)

Cusatuzumab 10 mg/kg Plus Azacitidine29.4 of 100

n = 51

Cusatuzumab 20 mg/kg Plus Azacitidine40.4 of 100

n = 52

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95% CI 18.7 to 43; Figures from the ClinicalTrials.gov results section (first posted 2024-07-30), not from a publication · 95% CI 28.2 to 53.9

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Percentage of Participants With Complete Remission (CR)primary	Cusatuzumab 10 mg/kg Plus Azacitidine	51	11.76%	-	-	link
	Cusatuzumab 20 mg/kg Plus Azacitidine	52	26.92%	-	-	link
Overall Response Rate (ORR)	Cusatuzumab 10 mg/kg Plus Azacitidine	51	29.4%	-	-	link
Overall Response Rate (ORR)	Cusatuzumab 20 mg/kg Plus Azacitidine	52	40.4%	-	-	link

Connected

Similar pages

cancers

Acute myeloid leukaemia

technologies

Cytotoxic chemotherapy Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)

drugs

ApprovedSmall-molecule hypomethylating agent (cytotoxic)

Azacitidine · Vidaza / Onureg (oral)

Phase 2monoclonal antibody

companies

argenx Johnson & Johnson OncoVerity