Trial Outcomes & Findings for SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission (NCT NCT02270463)

Last Updated: 2024-10-17

Results Overview

The maximum tolerated dose was defined as the dose preceding the dose level at which 2 or more patients experienced a DLT during treatment Cycle 1.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

16 participants

Primary outcome timeframe

24 weeks

Results posted on

2024-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Stage 1: Tagraxofusp-erzs 7 μg/kg/Day Tagraxofusp-erzs (SL-401) 7 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle.	Stage 1: Tagraxofusp-erzs 9 μg/kg/Day Tagraxofusp-erzs (SL-401) 9 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle.	Stage 1: Tagraxofusp-erzs 12 μg/kg/Day Tagraxofusp-erzs (SL-401) 12 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle.	Stage 2: Tagraxofusp-erzs 12 μg/kg/Day Tagraxofusp-erzs (SL-401) 12 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle.
Overall Study STARTED	3	3	3	7
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	3	3	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SL-401 as Consolidation Therapy in Patients With Adverse Risk Acute Myeloid Leukemia in First Complete Remission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stage 1: Tagraxofusp-erzs 7 μg/kg/Day n=3 Participants Tagraxofusp-erzs (SL-401) 7 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle	Stage 1: Tagraxofusp-erzs 9 μg/kg/Day n=3 Participants Tagraxofusp-erzs (SL-401) 7 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle	Stage 1: Tagraxofusp-erzs 12 μg/kg/Day n=3 Participants Tagraxofusp-erzs (SL-401) 12 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle	Stage 2: Tagraxofusp-erzs 12 μg/kg/Day n=7 Participants Tagraxofusp-erzs (SL-401) 12 μg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle	Total n=16 Participants Total of all reporting groups
Age, Continuous	66.0 years STANDARD_DEVIATION 7.00 • n=5 Participants	66.3 years STANDARD_DEVIATION 10.69 • n=7 Participants	59.0 years STANDARD_DEVIATION 7.00 • n=5 Participants	63.9 years STANDARD_DEVIATION 14.02 • n=4 Participants	63.8 years STANDARD_DEVIATION 10.67 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	9 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks

The maximum tolerated dose was defined as the dose preceding the dose level at which 2 or more patients experienced a DLT during treatment Cycle 1.

Outcome measures

Outcome measures
Measure	Stage 1: Tagraxofusp-erzs 7 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 7 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 9 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 9 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 12 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 2: Tagraxofusp-erzs 12 µg/kg/Day n=7 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.
Dose-Limiting Toxicity (DLT)	0 events	0 events	0 events	0 events

SECONDARY outcome

Timeframe: 24 weeks

The rate of MRD eradication (conversion) is defined as the proportion of patients with evidence of MRD prior to initial therapy with investigational SL-401 for whom MRD cannot be detected upon subsequent (post treatment) assessments.

Outcome measures

Outcome measures
Measure	Stage 1: Tagraxofusp-erzs 7 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 7 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 9 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 9 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 12 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 2: Tagraxofusp-erzs 12 µg/kg/Day n=7 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.
Eradication of Minimal Residual Disease (MRD) From Baseline MRD at Baseline	1 Participants	2 Participants	1 Participants	5 Participants
Eradication of Minimal Residual Disease (MRD) From Baseline MRD Eradicated at Single Assessment	1 Participants	1 Participants	0 Participants	0 Participants
Eradication of Minimal Residual Disease (MRD) From Baseline MRD Eradicated at Multiple Assessments	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 (enrollment) through Month 44

OS is defined as the time from the date of first infusion of SL-401 to the date of death from any cause. Participants still alive or lost to follow-up at the time of analysis were censored on the last date known to be alive prior to the analysis cutoff date, as determined by in-person visit or telephone contact.

Outcome measures

Outcome measures
Measure	Stage 1: Tagraxofusp-erzs 7 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 7 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 9 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 9 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 12 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 2: Tagraxofusp-erzs 12 µg/kg/Day n=7 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.
Overall Survival (OS)	12.2 months Interval 5.4 to Values were non-estimable (insufficient number of participants with events).	21.9 months Interval 2.6 to Values were non-estimable (insufficient number of participants with events).	19.0 months Values were non-estimable (insufficient number of participants with events). A median value is reported only since the survival curve crossed 0.5 probability. Only 1 participant experienced the event. The other 2 participants were censored due to a shorter OS duration.	NA months Interval 5.9 to Values were non-estimable (insufficient number of participants with events).

SECONDARY outcome

Timeframe: 24 weeks

RFS is defined as the proportion of patients who remain free of acute myeloid leukemia recurrence (hematologic) and alive.

Outcome measures

Outcome measures
Measure	Stage 1: Tagraxofusp-erzs 7 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 7 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 9 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 9 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 12 µg/kg/Day n=3 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 2: Tagraxofusp-erzs 12 µg/kg/Day n=7 Participants Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.
Relapse-Free Survival (RFS)	2.7 months Interval 0.5 to Values were non-estimable (insufficient number of participants with events).	5.1 months Interval 0.5 to Values were non-estimable (insufficient number of participants with events).	5.4 months Interval 3.0 to Values were non-estimable (insufficient number of participants with events).	5.0 months Interval 1.8 to 8.7

Adverse Events

Stage 1: Tagraxofusp-erzs 7 µg/kg/Day

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

Stage 1: Tagraxofusp-erzs 9 µg/kg/da

Serious events: 0 serious events

Other events: 3 other events

Deaths: 2 deaths

Stage 1: Tagraxofusp-erzs 12 µg/kg/Day

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Stage 2: Tagraxofusp-erzs 12 µg/kg/Day

Serious events: 4 serious events

Other events: 7 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Stage 1: Tagraxofusp-erzs 7 µg/kg/Day n=3 participants at risk Patients received tagraxofusp-erzs (SL-401) 7 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 9 µg/kg/da n=3 participants at risk Patients received tagraxofusp-erzs (SL-401) 9 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 1: Tagraxofusp-erzs 12 µg/kg/Day n=3 participants at risk Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.	Stage 2: Tagraxofusp-erzs 12 µg/kg/Day n=7 participants at risk Patients received tagraxofusp-erzs (SL-401) 12 µg/kg/day by IV infusion over 15 minutes for 5 consecutive days of a 28-day cycle in the absence of disease progression or other withdrawal criteria.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	14.3% 1/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Gastrointestinal disorders Irritable Bowel Syndrome	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	14.3% 1/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Gastrointestinal disorders Pancreatitis	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	14.3% 1/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
General disorders Pyrexia	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	14.3% 1/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	33.3% 1/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Psychiatric disorders Dysarthria	33.3% 1/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	33.3% 1/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	0.00% 0/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	33.3% 1/3 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.	14.3% 1/7 • Adverse events were assessed for up to 266 days. All-Cause Mortality was assessed for up to 44 months. An AE is any untoward medical occurrence in a study patient who is administered a medicinal product (drug or biologic); the event may or may not have a causal relationship with the medicinal product.

Other adverse events

Additional Information

Ira Gupta, MD, Senior Vice President, Clinical Development & Medical Affairs - Hematology

Stemline Therapeutics, Inc.

Phone: 1-877-332-7967

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place