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Clinical Trials/EUCTR2015-001611-12-IT
EUCTR2015-001611-12-IT
Active, not recruiting
Phase 1

A Randomized Phase 2/3 Study of DACOGEN¿ (Decitabine) Plus JNJ-56022473 (Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive Chemotherapy - An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabin

JANSSEN CILAG INTERNATIONAL NV0 sites326 target enrollmentStarted: June 17, 2021Last updated:
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ConditionsAcute Myeloid Leukemia (AML)MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsDACOGEN

Overview

Phase
Phase 1
Status
Active, not recruiting
Enrollment
326
OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •De novo or secondary acute myeloid leukemia (AML) according to WHO 2008 criteria
  • •For Part A: \-Participants With AML: treatment naive or relapsed for whom experimental therapy is appropriate (as assessed by their treating physician)
  • •For Part B: \=75 years of age or 65 up to 75 years of age and have at least one of the following:
  • •\-Congestive heart failure or ejection fraction \=50%
  • •\-Creatinine \>2 mg/dL, dialysis or prior renal transplant
  • •\-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
  • •\-ECOG performance status of 2
  • •\-Prior or current malignancy that does not require concurrent treatment
  • •\-Unresolved infection
  • •\-Comorbidity that, in the Investigator's opinion, makes the patient unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization

Exclusion Criteria

  • •\-Acute promyelocytic leukemia with t(15;17\), or its molecular equivalent (PMLRARalpha)
  • •\-For Part B only: Known leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
  • •\-Participants who received prior treatment with a hypomethylating agent
  • •\-ForPart A only: Participants who did not recover from all clinically significant toxicities (excluding alopecia and hematologic toxicities) of any
  • •previous surgery, radiotherapy, targeted therapy, or chemotherapy to less than or equal to Grade 1
  • •\-A diagnosis of other malignancy that requires concurrent treatment \-Any uncontrolled active systemic infection that requires treatment with
  • •IV antibiotics
  • •\-Active systemic hepatitis infection requiring treatment or other clinically active liver disease

Investigators

Similar Trials

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Phase 1
An Efficacy and Safety Study of Decitabine (DACOGEN) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.
EUCTR2015-001611-12-PLJanssen-Cilag International NV326
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.Acute Myeloid Leukemia (AML)MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2015-001611-12-BEJanssen-Cilag International NV326
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.Acute Myeloid Leukemia (AML)MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984Therapeutic area: Diseases [C] - Cancer [C04]
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An Efficacy and Safety Study of Decitabine (DACOGEN) Plus JNJ-56022473 (Anti CD123) Versus Decitabine (DACOGEN) alone in Participants with acute myeloid leukemia (AML) Ineligible for Intensive Chemotherapy.Acute Myeloid Leukemia (AML)MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2015-001611-12-DEJanssen-Cilag International NV400
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A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti-CD123) Versus DACOGEN (Decitabine) Alone in Patients with AML who are not Candidates for Intensive ChemotherapyAcute Myeloid Leukemia (AML)MedDRA version: 19.1Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
EUCTR2015-001611-12-FRJanssen-Cilag International NV326