Phase 3
Completed N=326
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
Leukemia, Myeloid, Acute
Source: ClinicalTrials.gov NCT02472145 ↗
Enrolled (actual)
326
Serious AEs
79.2%
Results posted
Feb 2019
Primary outcomePrimary: Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment — 11.9; 16.6 Percentage of participants — p=0.4747
◆ Published Evidence
Established
21citations · ~5 / year
Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia.
Summary
The primary objective of study Part A is to assess the safety of talacotuzumab (formerly CSL362) monotherapy and confirm the recommended Phase 2 dose (RP2D) in participants with acute myeloid leukemia (AML) for whom experimental therapy is appropriate. The primary objective of study Part B are to assess complete response (CR) rate and overall survival (OS) in participants with AML who are not eligible for intense induction chemotherapy and who are randomly assigned to receive decitabine plus talacotuzumab at the RP2D or decitabine alone.
Linked Publications
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Patient-reported outcomes predict overall survival in older patients with acute myeloid leukemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment |
11.9; 16.6 | 0.4747 |
| PRIMARY Part B: Overall Survival |
7.26; 5.36 | 0.7817 |
| SECONDARY Part B: Event-free Survival (EFS) Based on Investigator Assessment |
6.24; 4.50 | — |
| SECONDARY Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate) |
20.1; 26.8 | — |
| SECONDARY Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi) |
13.8; 21.3 | — |
| SECONDARY Part B: Time to Best Response |
16.71; 18.14 | — |
| SECONDARY Part B: Duration of Response (DOR) Based on Investigator Assessment |
23.71; NA | — |
Eligibility Criteria
Inclusion Criteria
- De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome [MDS] or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy) 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:
- Greater than or equal to (>=) 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 less than or equal to ( ) 2 milligram per deciliter (mg/dL); dialysis or prior renal transplant; documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) ] 45 years of age with amenorrhea for at least 12 months; If, of childbearing potential must be practicing a highly effective method of birth control
- A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at screening
- A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository for at least 3 months after last study treatment
Exclusion Criteria
- Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
- 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
- For Part 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
- Any uncontrolled active systemic infection that requires treatment with intravenous (IV) antibiotics
- A history of human immunodeficiency virus (HIV) antibody positive or tests positive for HIV if tested at screening
- Active systemic hepatitis infection requiring treatment or other clinically active liver disease
Data sourced from ClinicalTrials.gov (NCT02472145) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.