Leukemia, Myeloid, Acute
Conditions
Keywords
Leukemia, myeloid, acute, DACOGEN, Decitabine, JNJ-56022473, CLS362
Brief 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.
Detailed description
This is a 2-part, open-label, multicenter, Phase 2/3 study conducted in participants with AML who are suitable for experimental therapy (Part A) and in participants with untreated AML who are not eligible for intense induction chemotherapy or hematopoeitic stem cell transplantation (HSCT) (Part B). In Study Part A, the safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile will be assessed to confirm the RP2D of 9 milligram per kilogram (mg/kg) talacotuzumab. In Study Part B, participants will be randomized in a 1:1 ratio into either decitabine + talacotuzumab (arm 1) or decitabine alone (arm 2). Blood and bone marrow sampling will be done in Part A and B for disease assessment, PK, PD, and biomarkers will be collected in all participants. Safety will be monitored throughout the study.
Interventions
DRUGDecitabine 20 mg/m^2
Decitabine 20 milligram per square meter (mg/\[m\^2\]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.
DRUGTalacotuzumab 9 mg/kg
Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 (\<=) 50 percent; creatinine greater than (\>) 2 milligram per deciliter (mg/dL); dialysis or prior renal transplant; documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) \<= 65 percent of expected, or forced expiratory volume in 1 second (FEV1) \<= 65 percent of expected or dyspnea at rest requiring oxygen; eastern cooperative oncology group (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 participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization * Previously untreated AML (except: emergency leukopheresis and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of study therapy) * Not eligible for an allogeneic hematopoietic stem cell transplantation * ECOG Performance Status score of 0, 1 or 2 * A woman must be either: Not of childbearing potential: postmenopausal (more than \[\>\] 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment | Approximately up to 2.5 years | Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis. |
| Part B: Overall Survival | Approximately up to 2.5 years | Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part B: Event-free Survival (EFS) Based on Investigator Assessment | Approximately up to 2.5 years | EFS defined as time from randomization to treatment failure, relapse from CR/CRi, or death from any cause, whichever occurs first, per modified IWG criteria. Treatment failure: \>25% absolute increase in the bone marrow blast count from baseline to present assessment (example, 20% to 46%) on bone marrow aspirate (or biopsy in case of dry tap); Relapse: Bone marrow blasts greater than equal to (\>=)5%; reappearance of blasts in blood; or development of extramedullary disease; CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL);independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. Endpoint reported is for Part B only as per planned analysis. |
| Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate) | Approximately up to 2.5 years | Percentage of participants who achieved CR and CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/ mcL); platelet count \>100 \*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis. |
| Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi) | Approximately 2.5 years | Percentage of participants who achieved CR plus MRD-negative CRi were reported. MRD negativity defined as \<1 blast or leukemic stem cell in 10,000 leukocytes (MRD level \<10\^4).CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis. |
| Part B: Time to Best Response | Approximately 2.5 years | Time to best response is calculated as the time from the randomization date to the first documented date for the best response for participants who achieved CR or CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis. |
| Part B: Duration of Response (DOR) Based on Investigator Assessment | Approximately 2.5 years | DOR defined as number of weeks from documented best response (CR or CRi) for participants who achieved CR or CRi to relapse, death due to relapse, date of censoring. As per modified IWG criteria: CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease;absolute neutrophil count \>1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\* 10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis. |
Countries
Australia, Belgium, France, Germany, Israel, Poland, Russia, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Part A: Decitabine + JNJ-56022473 Participants received 1 dose of JNJ-56022473 (talacotuzumab) at 9 milligram per kilogram (mg/kg) as intravenous (IV) infusion on Day 1 of cycle 1. From cycle 2 onwards, participants received decitabine 20 milligram per meter square (mg/m\^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. | 10 |
| Part B: Decitabine (Alone) Participants received decitabine 20 mg/m\^2 IV on Days 1 to 5 of each 28-day cycle until treatment failure, relapse from CR or CRi, unacceptable toxicity, or death. | 159 |
| Part B: Decitabine + JNJ-56022473 Participants received decitabine 20 milligram per meter square (mg/m\^2) IV on Day 1 to Day 5 followed by 9 mg/kg JNJ-56022473 on Day 8 and Day 22 of a 28-day cycle until treatment failure, relapse from complete response/remission (CR) or complete response with incomplete recovery (CRi), unacceptable toxicity, or death. | 157 |
| Total | 326 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 10 | 101 | 99 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Other | 0 | 45 | 43 |
| Overall Study | Sponsor decision | 0 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 9 | 13 |
Baseline characteristics
| Characteristic | Total | Part B: Decitabine (Alone) | Part B: Decitabine + JNJ-56022473 | Part A: Decitabine + JNJ-56022473 |
|---|---|---|---|---|
| Age, Continuous | 74.8 years STANDARD_DEVIATION 5.91 | 75 years STANDARD_DEVIATION 5.6 | 75.2 years STANDARD_DEVIATION 5.32 | 65.4 years STANDARD_DEVIATION 10.88 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 4 Participants | 5 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 296 Participants | 143 Participants | 143 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 12 Participants | 9 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 25 Participants | 14 Participants | 11 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 8 Participants | 3 Participants | 5 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 22 Participants | 13 Participants | 9 Participants | 0 Participants |
| Race/Ethnicity, Customized White Non-Hispanic | 268 Participants | 127 Participants | 131 Participants | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants | 14 Participants | 11 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 13 Participants | 9 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) White | 284 Participants | 133 Participants | 141 Participants | 10 Participants |
| Region of Enrollment Australia | 28 Participants | 10 Participants | 18 Participants | 0 Participants |
| Region of Enrollment Belgium | 20 Participants | 11 Participants | 6 Participants | 3 Participants |
| Region of Enrollment France | 8 Participants | 6 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Germany | 32 Participants | 14 Participants | 18 Participants | 0 Participants |
| Region of Enrollment Israel | 29 Participants | 18 Participants | 11 Participants | 0 Participants |
| Region of Enrollment Italy | 23 Participants | 12 Participants | 11 Participants | 0 Participants |
| Region of Enrollment Korea, Republic Of | 12 Participants | 5 Participants | 7 Participants | 0 Participants |
| Region of Enrollment Poland | 24 Participants | 13 Participants | 11 Participants | 0 Participants |
| Region of Enrollment Russia | 56 Participants | 30 Participants | 26 Participants | 0 Participants |
| Region of Enrollment Spain | 43 Participants | 17 Participants | 19 Participants | 7 Participants |
| Region of Enrollment Sweden | 2 Participants | 2 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Taiwan, Province Of China | 12 Participants | 8 Participants | 4 Participants | 0 Participants |
| Region of Enrollment Turkey | 7 Participants | 2 Participants | 5 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 4 Participants | 1 Participants | 3 Participants | 0 Participants |
| Region of Enrollment United States | 26 Participants | 10 Participants | 16 Participants | 0 Participants |
| Sex: Female, Male Female | 149 Participants | 68 Participants | 77 Participants | 4 Participants |
| Sex: Female, Male Male | 177 Participants | 91 Participants | 80 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 10 / 10 | 101 / 159 | 99 / 157 |
| other Total, other adverse events | 9 / 10 | 157 / 165 | 146 / 147 |
| serious Total, serious adverse events | 9 / 10 | 120 / 165 | 126 / 147 |
Outcome results
Primary
Part B: Overall Survival
Overall Survival (OS) was defined as the time from the date of randomization to date of death from any cause. Median Overall Survival was estimated by using the Kaplan-Meier method. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately up to 2.5 years
Population: ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Overall Survival | 7.26 Months |
| Part B: Decitabine + JNJ-56022473 | Part B: Overall Survival | 5.36 Months |
Comparison: Statistical Analysis 1p-value: 0.781795% CI: [0.79, 1.37]Log Rank
Primary
Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment
Complete response rate defined as percentage of participants who achieved complete response as per modified International Working Group (IWG) criteria. CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/micro liter \[mcL\]); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately up to 2.5 years
Population: Intent-to-Treat (ITT) population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment | 11.9 Percentage of participants |
| Part B: Decitabine + JNJ-56022473 | Part B: Percentage of Participants Who Achieved Complete Response (Complete Response Rate) Based on Investigator Assessment | 16.6 Percentage of participants |
Comparison: Statistical Analysis 1p-value: 0.474795% CI: [0.8, 2.8]Chi-squared
Secondary
Part B: Duration of Response (DOR) Based on Investigator Assessment
DOR defined as number of weeks from documented best response (CR or CRi) for participants who achieved CR or CRi to relapse, death due to relapse, date of censoring. As per modified IWG criteria: CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease;absolute neutrophil count \>1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\* 10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately 2.5 years
Population: Population included participants in ITT, who achieved CR or CRi.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Duration of Response (DOR) Based on Investigator Assessment | 23.71 Weeks |
| Part B: Decitabine + JNJ-56022473 | Part B: Duration of Response (DOR) Based on Investigator Assessment | NA Weeks |
Secondary
Part B: Event-free Survival (EFS) Based on Investigator Assessment
EFS defined as time from randomization to treatment failure, relapse from CR/CRi, or death from any cause, whichever occurs first, per modified IWG criteria. Treatment failure: \>25% absolute increase in the bone marrow blast count from baseline to present assessment (example, 20% to 46%) on bone marrow aspirate (or biopsy in case of dry tap); Relapse: Bone marrow blasts greater than equal to (\>=)5%; reappearance of blasts in blood; or development of extramedullary disease; CR: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \> 1.0\*10\^9/L (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL);independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. Endpoint reported is for Part B only as per planned analysis.
Time frame: Approximately up to 2.5 years
Population: ITT population defined as all randomized participants, grouped per treatment assigned by randomization, regardless of actual treatment received.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Event-free Survival (EFS) Based on Investigator Assessment | 6.24 Months |
| Part B: Decitabine + JNJ-56022473 | Part B: Event-free Survival (EFS) Based on Investigator Assessment | 4.50 Months |
Secondary
Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate)
Percentage of participants who achieved CR and CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/ mcL); platelet count \>100 \*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately up to 2.5 years
Population: ITT population is defined as all randomized participants, grouped per treatment assigned by randomization, regardless of the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate) | 20.1 Percentage of Participants |
| Part B: Decitabine + JNJ-56022473 | Part B: Percentage of Participants Who Achieved CR and CRi (Overall Response Rate) | 26.8 Percentage of Participants |
Secondary
Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi)
Percentage of participants who achieved CR plus MRD-negative CRi were reported. MRD negativity defined as \<1 blast or leukemic stem cell in 10,000 leukocytes (MRD level \<10\^4).CR: Bone marrow blasts less than (\<)5 percent (%); absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0\*10\^9/liter (L) (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately 2.5 years
Population: Population included participants in ITT, among whom MRD negativity was evaluated upon achieving response.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi) | 13.8 Percentage of participants |
| Part B: Decitabine + JNJ-56022473 | Part B: Percentage of Participants With Complete Response (CR) Plus Minimal Residual Disease (MRD) Negative Complete Response With Incomplete Recovery (CRi) | 21.3 Percentage of participants |
Secondary
Part B: Time to Best Response
Time to best response is calculated as the time from the randomization date to the first documented date for the best response for participants who achieved CR or CRi, as per modified IWG criteria. CR: Bone marrow blasts less than (\<)5 %; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count greater than (\>)1.0 \*10\^9/liter (L) (1000/mcL); platelet count \>100\*10\^9/L (100 000/mcL); independence of red cell transfusions; CRi: Bone marrow blasts \<5 %; absence of blasts with Auer rods; absence of extramedullary disease; residual neutropenia \<1.0\*10\^9/L (1000/mcL) or thrombocytopenia \<100\*10\^9/L (100 000/mcL); independence of red cell transfusions. This endpoint is reported here for Part B only as per the planned analysis.
Time frame: Approximately 2.5 years
Population: Population included participants in ITT, who achieved CR or CRi.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Part B: Decitabine (Alone) | Part B: Time to Best Response | 16.71 Weeks |
| Part B: Decitabine + JNJ-56022473 | Part B: Time to Best Response | 18.14 Weeks |