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Clinical Trial NCT04023526 (CULMINATE) for Leukemia, Myeloid, Acute is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy (CULMINATE) Phase 2 103
Clinical Trial NCT04023526 (CULMINATE) is designed to study Treatment for Leukemia, Myeloid, Acute. It is a Phase 2 interventional study that is active, not recruiting, having started on 29 July 2019, with plans to enroll 103 participants. Led by OncoVerity, Inc., it is expected to complete by 15 May 2026. The latest data from ClinicalTrials.gov was last updated on 20 August 2025.
Brief Summary
The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.
Detailed Description
AML is a heterogeneous disease characterized by uncontrolled clonal expansion of hematopoietic progenitor cells. As the most common form of acute leukemia, AML accounts for the largest number of annual deaths from leukemia. Over 95 percent (%) of AML blasts harvested from newly diagnosed AML participants expressed Cluster of Differentiation (CD) 70 on the cell surface. Cusatuzumab (JNJ-74494550) is a humanized monocl...Show More
Official Title
A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
Conditions
Leukemia, Myeloid, AcutePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- CULMINATE
- CULM20236
- 2019-000473-23 (EudraCT Number)
- CULM20236 (Other Identifier) (OncoVerity, Inc.)
- 74494550AML2001 (Other Identifier) (Janssen Research & Development, LLC)
NCT ID Number
Start Date (Actual)
2019-07-29
Last Update Posted
2025-08-20
Completion Date (Estimated)
2026-05-15
Enrollment (Estimated)
103
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalAzacitidine 75 mg/m^2 and Cusatuzumab 10 mg/kg Participants will receive azacitidine 75 milligram per meter square (mg/m\^2) subcutaneously (SC) or intravenously (IV) on Day 1 through Day 7 and cusatuzumab 10 milligram per kilogram (mg/kg) IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee. | Azacitidine Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle. Cusatuzumab Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle. |
ExperimentalAzacitidine 75 mg/m^2 and Cusatuzumab 20 mg/kg Participants will receive azacitidine 75 mg/m\^2 SC or IV on Day 1 through Day 7 and cusatuzumab 20 mg/kg IV on Day 3 and Day 17 of each 28-day cycle in Part 1. Part 1 findings will be reviewed by a data review committee. | Azacitidine Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle. Cusatuzumab Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percentage of Participants With Complete Remission (CR) | Complete remission based on European Leukemia Network (ELN) 2017 response criteria. Defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L | Up to 3 years and 5 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Percentage of Participants With CR With Partial Hematological Recovery (CRh) | CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L | Up to 3 years and 5 months |
Percentage of Participants With CR Plus CRh | CR plus CRh based on ELN 2017 response criteria. CR defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absences of extramedullary disease; ANC \>= 1.0 x10\^9/L; platelet count \>=100 x 10\^9/L CRh defined as meeting all criteria for CR except ANC \>0.5x10\^9/L and platelet count \>50x10\^9/L | Up to 3 years and 5 months |
Percentage of Participants With CR With Incomplete Recovery (CRi) | CRi based on ELN 2017 response criteria. Defined as meeting all CR criteria except for residual neutropenia (ANC \<1.0x10\^9/L) or thrombocytopenia (platelets \<100x10\^9/L) | Up to 3 years and 5 months |
Overall Response Rate (ORR) | ORR is defined as percentage of participants with CR, CRh and CRi based on ELN 2017 response criteria. | Up to 3 years and 5 months |
Percentage of Participants With CR Without MRD | CR without minimal residual disease (MRD) defined as less than 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3 by flow cytometry). | Up to 3 years and 5 months |
Percentage of Participants With Negative MRD Who Achieved CR, CRh, CRi, or Morphologic Leukemia-free State (MLFS) | Percentage of participants with negative MRD who achieved CR, CRh, CRi, or MLFS will be reported and is defined as less than (\<) 1 blast or leukemic stem cell in 1,000 leukocytes (MRD level \<10\^-3). | Up to 3 years and 5 months |
Time to First Response | Defined as time from randomization to achieving the first response of CR, CRh, or CRi. | Up to 3 years and 5 months |
Duration of First Response | Defined as time from achieving the first response of CR, CRh, or CRi to disease relapse or death from any cause. | Up to 3 years and 5 months |
Red Blood Cell (RBC) and/or Platelets Transfusion Independence | Defined as a period of at least 56 consecutive days with no transfusion of RBC and/or platelets between first dose of study drug and the last dose of study drug +30 days. | Up to 3 years and 5 months |
Cusatuzumab Minimum Serum Concentration (Cmin) | Cmin is the minimum cusatuzumab serum concentration observed at Cycle 1 Day 3 | Cycle 1 Day 3 |
Maximum Serum Concentration (Cmax) of Cusatuzumab | Cmax is the maximum cusatuzumab serum concentration observed at Cycle 1 Day 3. | Cycle 1 Day 3 |
Number of Participants With Anti-cusatuzumab Antibodies | Number of participants exhibiting anti-drug antibodies for cusatuzumab. | Up to 3 years and 5 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines those who are "not candidates for intensive chemotherapy":
- greater than or equal to (>=)75 years of age or
- less than (<) 75 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2; Severe cardiac comorbidity defined as congestive heart failure or ejection fraction less than or equal to (<=) 50 percent (%); Severe pulmonary comorbidity defined as documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) <=65% of expected, or forced expiratory volume in 1 second (FEV1) <=65% of expected or dyspnea at rest requiring oxygen; Moderate hepatic impairment defined according to NCI organ dysfunction classification criteria (total bilirubin >=1.5 up to 3 times upper limit of normal \[ULN\]); Creatinine clearance <45 milliliter per minute per 1.73 meter square (mL/ min/1.73 m^2); Comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization
De novo or secondary AML
Previously untreated AML (except: emergency leukapheresis, hydroxyurea, and/or 1 dose of cytarabine \[example: 1-2 gram per meter square {g/m\^2}\] during the Screening Phase to control hyperleukocytosis. These treatments must be discontinued >=24 hours prior to start of study drug). Empiric all trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but APL must be ruled out and ATRA must be discontinued >=24 hours prior to the start of study drug
Not eligible for an allogeneic hematopoietic stem cell transplantation
ECOG Performance Status score of 0, 1 or 2
- Acute promyelocytic leukemia
- Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
- Use of immune suppressive agents for the past 4 weeks before the first administration of cusatuzumab on Cycle 1 Day 3. For regular use of systemic corticosteroids, participants may only be included if free of systemic corticosteroids for a minimum of 5 days before the first administration of cusatuzumab. Treatment of adrenal insufficiency with physiologic replacement doses of corticosteroids are allowed
- Prior treatment with a hypomethylating agent for treatment of AML or myelodysplastic syndrome (MDS)
- Active malignancies (that is, progressing or requiring treatment in the last 24 months) other than the disease being treated under the study
- Any active systemic infection
- Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (that is, mannitol, an excipient of azacitidine)
OncoVerity, Inc.- Janssen Research & Development, LLC
No contact data.
56 Study Locations in 9 Countries
St Vincents Hospital Sydney, Darlinghurst, 2010, Australia
St Vincents Hospital Melbourne, Fitzroy, 3065, Australia
The Alfred Hospital, Melbourne, 3004, Australia
Royal Perth Hospital, Perth, 6000, Australia
Westmead Hospital, Westmead, 2145, Australia
Universidade Estadual De Campinas, Campinas, 13083-878, Brazil
Hospital das Clinicas de Porto Alegre, Porto Alegre, 90035-903, Brazil
CHU d'Angers, Angers, 49933, France
CHU Grenoble, Grenoble, 38043, France
Institut Paoli Calmettes, Marseille, 13273, France
Centre Hospitalier Universitaire (CHU) de Bordeaux Hopital HautLeveque Centre Francois Magendie, Pessac, 33600, France
CHU Lyon Sud, Pierre-Bénite, 69495, France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, 31059, France
CHRU Tours Hôpital Bretonneau, Tours, 37000, France
Rambam Medical Center, Haifa, 31096, Israel
Hadassah Medical Center, Jerusalem, 9112001, Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, 64239, Israel
Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna, Bologna, 40138, Italy
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, 25123, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, 47014, Italy
Istituto Europeo di Oncologia, Milan, 20141, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milan, 20162, Italy
Division of Hematology, Cardarelli Hospital, Naples, 80131, Italy
Azienda Sanitaria Universitaria Integrata di Udine, Udine, 33100, Italy
Chelyabinck Regional Clinical Hospital, Chelyabinsk, 454076, Russia
S.P. Botkin Moscow City Clinical Hospital, Moscow, 125284, Russia
City Clinical Hospital # 40, Moscow, 129301, Russia
Nizhniy Novgorod Region Clinical Hospital, Nizhny Novgorod, 603126, Russia
Ryazan Regional Clinical Hospital, Ryazan, 390039, Russia
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology, Saint Petersburg, 193024, Russia
City clinical hospital #15, Saint Petersburg, 198205, Russia
Samara Region Clinical Hospital, Samara, 443095, Russia
Oncologic Dispensary No.2, Sochi, 354057, Russia
Komi Republic Oncology dispensary, Syktyvkar, 167904, Russia
Ekaterinburg City Clinical Hospital # 7, Yekaterinburg, 620137, Russia
Madrid
Hosp. Quiron Madrid Pozuelo, Pozuelo de Alarcón, Madrid, 28223, Spain
Hosp. de La Santa Creu I Sant Pau, Barcelona, 08025, Spain
Inst. Cat. Doncologia-H Duran I Reynals, Barcelona, 08908, Spain
Hosp. Univ. Vall D Hebron, Barcelona, 8035, Spain
Hosp. Reina Sofia, Córdoba, 14004, Spain
Hosp. Univ. Ramon Y Cajal, Madrid, 28034, Spain
Hosp. Univ. 12 de Octubre, Madrid, 28041, Spain
Hosp. Univ. Son Espases, Palma, 7120, Spain
Hosp. Clinico Univ. de Salamanca, Salamanca, 37007, Spain
Hosp. Univ. I Politecni La Fe, Valencia, 46026, Spain
Kantonsspital Aarau, Aarau, 5001, Switzerland
INSELSPITAL, Universitätsspital Bern, Bern, 3010, Switzerland
Hopitaux Universitaires de Geneve, Geneva, 1205, Switzerland
UniversitaetsSpital Zuerich, Zurich, Switzerland
Gulhane Egitim ve Arastirma Hastanesi, Ankara, 06010, Turkey (Türkiye)
Dr.Abdurrahman Yurtaslan Oncology Training and Research Hospital, Ankara, 06200, Turkey (Türkiye)
Ankara University Medical Faculty Hematology Department - Hematology, Ankara, 6100, Turkey (Türkiye)
Istanbul Egitim ve Arastirma Hastanesi, Istanbul, 34098, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi, Izmir, 35210, Turkey (Türkiye)
Ondokuz Mayis Universitesi Tip Fakultesi, Samsun, 55139, Turkey (Türkiye)
Karadeniz Teknik University Medical Faculty, Trabzon, 61080, Turkey (Türkiye)