Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

A Randomized, Double-blind Phase 3 Study of Vadastuximab Talirine (SGN-CD33A) Versus Placebo in Combination With Azacitidine or Decitabine in the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02785900

Acronym

CASCADE

Enrollment

240

Registered

2016-05-30

Start date

2016-05-31

Completion date

2017-10-03

Last updated

2018-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

Antibodies, monoclonal, Antibody drug conjugate, Antigens, cluster of differentiation 33 (CD33), Drug therapy, Immunotherapy

Brief summary

The purpose of this study in AML patients is to test whether vadastuximab talirine (SGN-CD33A; 33A) combined with either azacitidine or decitabine improves remission rates and extends overall survival as compared to placebo combined with either azacitidine or decitabine.

Detailed description

Hypomethylating agents (HMAs), such as decitabine or azacitidine, are considered a standard treatment for older patients with AML. The primary goals of this study are to test whether patients treated with an HMA (either decitabine or azacitidine) in combination with 33A will have better anti-tumor activity and/or survive longer than patients treated with an HMA in combination with placebo. Patients who meet eligibility criteria will be randomly assigned to one of two treatment groups: 1) 33A plus HMA (Experimental Arm); or 2) placebo plus HMA (Comparator Arm). In addition to evaluating survival and remission rates, the minimal residual disease (MRD)-negative remission rate, duration of remission, event free- and leukemia-free survival, and safety and tolerability will be compared between arms.

Interventions

DRUG33A

33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push

DRUGplacebo

Volume equivalent to 10 mcg/kg, every 4 weeks via IV push

DRUGazacitidine

75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks

DRUGdecitabine

20 mg/m2 given IV x 5 days, every 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL)) * Intermediate or adverse cytogenetic risk * Eligible for therapy with either decitabine or azacitidine * Acceptable hematologic and organ function

Exclusion criteria

* AML associated with favorable risk karyotypes including inv(16), t(8;21), t(16;16), or t(15;17) * Patients who are candidates for allogeneic stem cell transplant at the time of enrollment * Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis * Received prior treatment with HMA or chemotherapy for antecedent myelodysplastic syndrome (MDS)

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	Up to 1.5 years	Time from randomization to death due to any cause
Composite Complete Remission (CRc) Rate	Up to 1.5 years	Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

Secondary

Measure	Time frame	Description
Event-free Survival	Up to approximately 11.24 months	Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.
Leukemia-free Survival	Up to approximately 9.49 months	Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.
Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Up to 1.5 years	Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. Study treatment in this data set refers to blinded study treatment.
Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	Up to 1.5 years	Number of patients who achieve both remission (CR or CRi) and MRD-negative status
Time to Complete Remission	Up to 1.5 years	Time to CR or CRi is the time from randomization to the first documentation of CR/CRi
Mortality Rates at Day 30 and Day 60	Up to 60 days	30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.
Incidence of Grade 3 or Higher Laboratory Abnormalities	Up to 1.5 years	Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\], v4.03)
Duration of Remission	Up to approximately 9.5 months	Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Countries

Australia, Austria, Belgium, Czechia, France, Germany, Hungary, Israel, Italy, Luxembourg, Poland, South Korea, Spain, Taiwan, United Kingdom, United States

Participant flow

Participants by arm

Arm	Count
33A + HMA 33A plus azacitidine or decitabine 33A: 33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	117
Placebo + HMA placebo plus azacitidine or decitabine placebo: Volume equivalent to 10 mcg/kg, every 4 weeks via IV push azacitidine: 75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks decitabine: 20 mg/m2 given IV x 5 days, every 4 weeks	123
Total	240

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	46	32
Overall Study	Physician Decision	3	2
Overall Study	Study Termination by Sponsor	64	81
Overall Study	Withdrawal by Subject	4	8

Baseline characteristics

Characteristic	Placebo + HMA	Total	33A + HMA
Age, Continuous	75.0 years	75.0 years	75.0 years
Age, Customized Age Group 65 - 74 years	55 Participants	110 Participants	55 Participants
Age, Customized Age Group >65 years	3 Participants	6 Participants	3 Participants
Age, Customized Age Group 75 - 79 years	41 Participants	74 Participants	33 Participants
Age, Customized Age Group >= 80 years	24 Participants	50 Participants	26 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0: Normal activity	23 Participants	46 Participants	23 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1: Symptoms but ambulatory	80 Participants	158 Participants	78 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2: In bed less than 50% of the time	20 Participants	36 Participants	16 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	5 Participants	3 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	111 Participants	209 Participants	98 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	10 Participants	26 Participants	16 Participants
Race/Ethnicity, Customized Race American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Asian	16 Participants	28 Participants	12 Participants
Race/Ethnicity, Customized Race Black or African American	1 Participants	4 Participants	3 Participants
Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race/Ethnicity, Customized Race Not Reportable	10 Participants	23 Participants	13 Participants
Race/Ethnicity, Customized Race Other	1 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Race Unknown	1 Participants	3 Participants	2 Participants
Race/Ethnicity, Customized Race White	94 Participants	179 Participants	85 Participants
Region of Enrollment Australia	11 participants	21 participants	10 participants
Region of Enrollment Austria	0 participants	3 participants	3 participants
Region of Enrollment Belgium	8 participants	12 participants	4 participants
Region of Enrollment Czechia	6 participants	9 participants	3 participants
Region of Enrollment France	10 participants	23 participants	13 participants
Region of Enrollment Germany	6 participants	8 participants	2 participants
Region of Enrollment Hungary	6 participants	11 participants	5 participants
Region of Enrollment Israel	7 participants	12 participants	5 participants
Region of Enrollment Italy	3 participants	5 participants	2 participants
Region of Enrollment South Korea	7 participants	13 participants	6 participants
Region of Enrollment Spain	6 participants	11 participants	5 participants
Region of Enrollment Taiwan	5 participants	10 participants	5 participants
Region of Enrollment United Kingdom	3 participants	8 participants	5 participants
Region of Enrollment United States	45 participants	94 participants	49 participants
Sex: Female, Male Female	67 Participants	136 Participants	69 Participants
Sex: Female, Male Male	56 Participants	104 Participants	48 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	43 / 111	34 / 128
other Total, other adverse events	105 / 111	123 / 128
serious Total, serious adverse events	92 / 111	89 / 128

Outcome results

Primary

Composite Complete Remission (CRc) Rate

Number of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) according to the modified response criteria for acute myeloid leukemia (AML) per Cheson 2003.

Time frame: Up to 1.5 years

Population: Intent-to-treat analysis set

Arm	Measure	Value (NUMBER)
33A + HMA	Composite Complete Remission (CRc) Rate	30 participants
Placebo + HMA	Composite Complete Remission (CRc) Rate	26 participants

Primary

Overall Survival

Time from randomization to death due to any cause

Time frame: Up to 1.5 years

Population: Intent-to-treat analysis set

Arm	Measure	Value (MEDIAN)
33A + HMA	Overall Survival	5.1 months
Placebo + HMA	Overall Survival	NA months

Secondary

Duration of Remission

Duration of remission is calculated from the first documentation of CR or CRi to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Time frame: Up to approximately 9.5 months

Population: Patients who achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi).

Arm	Measure	Value (MEDIAN)
33A + HMA	Duration of Remission	5.1 months
Placebo + HMA	Duration of Remission	7.5 months

Secondary

Event-free Survival

Event-free survival is calculated from the time of randomization to the first documentation of progression, relapse, or death, whichever comes first. Patients who do not have event (progression, relapse, or death) prior to analysis cutoff date are censored at the date of last response assessment. Patients who started another anticancer therapy before progression, relapse, or death are censored at the date of last response assessment prior to the start of new therapy. Patients who do not have response assessment post-baseline are censored at the date of randomization.

Time frame: Up to approximately 11.24 months

Population: Intent-to-treat analysis set

Arm	Measure	Value (MEDIAN)
33A + HMA	Event-free Survival	4.2 months
Placebo + HMA	Event-free Survival	6.7 months

Secondary

Incidence of Grade 3 or Higher Laboratory Abnormalities

Participants who experienced a laboratory grade increase to Grade 3 or higher (per National Cancer Institute's Common Terminology Criteria for Adverse Events \[NCI CTCAE\], v4.03)

Time frame: Up to 1.5 years

Population: Safety Analysis Set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Potassium (mEq/L) - High	1 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Albumin (g/dL) - Low	2 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Potassium (mEq/L) - Low	5 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Calcium (mg/dL) - Low	8 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Sodium (mEq/L) - Low	13 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Amylase (IU/L) - High	1 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Triacylglycerol Lipase (IU/L) - High	10 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Creatinine (mg/dL) - High	0 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Urate (mg/dL) - High	4 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Alanine Aminotransferase (IU/L) - High	0 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Hemoglobin (g/dL) - Low	59 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Glucose (mg/dL) - High	12 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Leukocytes (x10^3/uL) - High	0 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Aspartate Aminotransferase (IU/L) - High	1 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Leukocytes (x10^3/uL) - Low	86 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Magnesium (mg/dL) - High	2 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Lymphocytes (x10^3/uL) - High	1 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Alkaline Phosphatase (IU/L) - High	0 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Lymphocytes (x10^3/uL) - Low	51 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Phosphate (mg/dL) - Low	17 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Neutrophils (x10^3/uL) - Low	63 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Platelets (x10^3/uL) - Low	77 Participants
33A + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Bilirubin (mg/dL) - High	1 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Platelets (x10^3/uL) - Low	75 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Alanine Aminotransferase (IU/L) - High	2 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Albumin (g/dL) - Low	4 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Alkaline Phosphatase (IU/L) - High	2 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Amylase (IU/L) - High	0 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Aspartate Aminotransferase (IU/L) - High	2 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Bilirubin (mg/dL) - High	1 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Calcium (mg/dL) - Low	3 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Creatinine (mg/dL) - High	1 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Glucose (mg/dL) - High	9 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Magnesium (mg/dL) - High	0 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Phosphate (mg/dL) - Low	9 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Potassium (mEq/L) - High	0 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Potassium (mEq/L) - Low	14 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Sodium (mEq/L) - Low	12 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Triacylglycerol Lipase (IU/L) - High	4 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Urate (mg/dL) - High	7 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Hemoglobin (g/dL) - Low	66 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Leukocytes (x10^3/uL) - High	3 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Leukocytes (x10^3/uL) - Low	70 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Lymphocytes (x10^3/uL) - High	4 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Lymphocytes (x10^3/uL) - Low	29 Participants
Placebo + HMA	Incidence of Grade 3 or Higher Laboratory Abnormalities	Neutrophils (x10^3/uL) - Low	43 Participants

Secondary

Leukemia-free Survival

Leukemia-free survival is calculated from the first documentation of blast clearance (CR, CRi, mLFS) to the first documentation of disease relapse or death, whichever comes first. Patients who are in remission at the time of analysis cutoff are censored at the date of last response assessment. Patients who started another anticancer therapy before relapse or death are censored at the date of last response assessment prior to start of new therapy.

Time frame: Up to approximately 9.49 months

Population: Patients who achieved CR/CRi

Arm	Measure	Value (MEDIAN)
33A + HMA	Leukemia-free Survival	5.1 months
Placebo + HMA	Leukemia-free Survival	7.5 months

Secondary

Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate

Number of patients who achieve both remission (CR or CRi) and MRD-negative status

Time frame: Up to 1.5 years

Population: Intent-to-treat analysis set

Arm	Measure	Group	Value (NUMBER)
33A + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CRc rate	18 participants
33A + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CR rate	8 participants
33A + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CRi rate	10 participants
Placebo + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CRc rate	10 participants
Placebo + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CR rate	5 participants
Placebo + HMA	Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate	MRD-negative CRi rate	5 participants

Secondary

Mortality Rates at Day 30 and Day 60

30- and 60-day survival from date of randomization. Estimated using Kaplan-Meier method.

Time frame: Up to 60 days

Population: Intent-to-Treat Analysis Set

Arm	Measure	Group	Value (NUMBER)
33A + HMA	Mortality Rates at Day 30 and Day 60	30-day Mortality Rate	11 percentage of participants
33A + HMA	Mortality Rates at Day 30 and Day 60	60-day Mortality Rate	23 percentage of participants
Placebo + HMA	Mortality Rates at Day 30 and Day 60	30-day Mortality Rate	6 percentage of participants
Placebo + HMA	Mortality Rates at Day 30 and Day 60	60-day Mortality Rate	13 percentage of participants

Secondary

Time to Complete Remission

Time to CR or CRi is the time from randomization to the first documentation of CR/CRi

Time frame: Up to 1.5 years

Population: Intent-to-Treat Analysis Set - Patients who Achieved CR/CRi.

Arm	Measure	Value (MEDIAN)
33A + HMA	Time to Complete Remission	9.3 weeks
Placebo + HMA	Time to Complete Remission	9.4 weeks

Secondary

Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events

Treatment-emergent adverse events (TEAEs) are presented and defined as newly occurring (not present at baseline) or worsening after first dose of investigational product. SAE = serious adverse event. Study treatment in this data set refers to blinded study treatment.

Time frame: Up to 1.5 years

Population: Safety analysis set: 7 patients randomized to the HMA+33A received only HMA and are included in the HMA+Placebo safety set. 1 patient randomized to the HMA+placebo arm received 33A+HMA treatment. 1 patient in the HMA+placebo arm did not receive any study treatment.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
33A + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any AE related to study treatment	83 Participants
33A + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any SAE related to study treatment	51 Participants
33A + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any SAE	92 Participants
33A + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with Grade 3 or Higher AE	103 Participants
33A + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patient with any TEAE	111 Participants
Placebo + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with Grade 3 or Higher AE	112 Participants
Placebo + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patient with any TEAE	125 Participants
Placebo + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any AE related to study treatment	59 Participants
Placebo + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any SAE	89 Participants
Placebo + HMA	Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events	Patients with any SAE related to study treatment	20 Participants

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Conditions

Keywords

Brief summary

Detailed description

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Composite Complete Remission (CRc) Rate

Overall Survival

Duration of Remission

Event-free Survival

Incidence of Grade 3 or Higher Laboratory Abnormalities

Leukemia-free Survival

Minimal Residual Disease (MRD)-Negative Composite Complete Remission Rate

Mortality Rates at Day 30 and Day 60

Time to Complete Remission

Type, Incidence, Severity, Seriousness, and Relatedness of Adverse Events