Trial Outcomes & Findings for Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia (NCT NCT03071276)

Last Updated: 2020-05-22

Results Overview

Complete response or complete response with incomplete count recovery or partial response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Results posted on

2020-05-22

Participant Flow

Participants must have a diagnosis of AML and must have disease that has relapsed or is refractory to chemotherapy, or that has relapsed after hematopoietic stem cell transplantation (HSCT).

Participant milestones

Participant milestones
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine Interventions: Selinexor, Fludarabine, and Cytarabine
Overall Study STARTED	37
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Reasons for withdrawal
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine Interventions: Selinexor, Fludarabine, and Cytarabine
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	14

Baseline Characteristics

Selinexor in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=37 Participants Interventions: Selinexor, Fludarabine, and Cytarabine
Age, Continuous	8.04 years STANDARD_DEVIATION 6.25 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Population: Patients with response data available

Outcome measures

Outcome measures
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=28 Participants Interventions: Selinexor, Fludarabine, and Cytarabine
The Overall Response (OR) Rate (Complete Response + Incomplete Count Recovery + Partial Response)	53.6 percentage of participants Interval 33.9 to 72.5

PRIMARY outcome

Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Population: Patients with response data available

Complete response, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study

Outcome measures

Outcome measures
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=28 Participants Interventions: Selinexor, Fludarabine, and Cytarabine
Complete Response	46.4 percentage of participants Interval 27.5 to 66.1

PRIMARY outcome

Timeframe: Between days 28 and 35 of cycle 1 (cycle length is 42-56 days)

Population: Patients with response data available

Complete response or complete response with incomplete count recovery, of selinexor in combination with fludarabine and cytarabine for patients with relapsed or refractory AML in the phase II portion of the study

Outcome measures

Outcome measures
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=28 Participants Interventions: Selinexor, Fludarabine, and Cytarabine
Complete Response or Complete Response With Incomplete Count Recovery	50.0 percentage of participants Interval 30.6 to 69.4

Adverse Events

Interventions: Selinexor, Fludarabine, and Cytarabine

Serious events: 1 serious events

Other events: 36 other events

Deaths: 22 deaths

Serious adverse events

Serious adverse events
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=37 participants at risk Interventions: Selinexor, Fludarabine, and Cytarabine
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Cardiac disorders Pericardial effusion	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.

Other adverse events

Other adverse events
Measure	Interventions: Selinexor, Fludarabine, and Cytarabine n=37 participants at risk Interventions: Selinexor, Fludarabine, and Cytarabine
General disorders Graft Versus host disease	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Blood and lymphatic system disorders Anemia	81.1% 30/37 • Number of events 133 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Blood and lymphatic system disorders Febrile neutropenia	48.6% 18/37 • Number of events 28 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Abdominal pain	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Diarrhea	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Enterocolitis	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Esophagitis	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Nausea	2.7% 1/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Oral pain	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Gastrointestinal disorders Vomiting	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
General disorders Edema limbs	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
General disorders Fever	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
General disorders Flu like symptoms	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
General disorders Pain	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Immune system disorders Allergic reaction	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Enterocolitis infectious	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Infections and infestations - Other, specify	10.8% 4/37 • Number of events 6 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Lung infection	18.9% 7/37 • Number of events 10 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Otitis media	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Sepsis	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Sinusitis	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Skin infection	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Soft tissue infection	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Upper respiratory infection	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Urinary tract infection	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Infections and infestations Wound infection	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Alanine aminotransferase increased	16.2% 6/37 • Number of events 8 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Aspartate aminotransferase increased	18.9% 7/37 • Number of events 10 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Blood bilirubin increased	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Creatinine increased	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Electrocardiogram QT corrected interval prolonged	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations GGT increased	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Lymphocyte count decreased	62.2% 23/37 • Number of events 89 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Neutrophil count decreased	83.8% 31/37 • Number of events 103 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Platelet count decreased	89.2% 33/37 • Number of events 360 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations Weight loss	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Investigations White blood cell decreased	78.4% 29/37 • Number of events 133 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Anorexia	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Dehydration	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hyperglycemia	29.7% 11/37 • Number of events 16 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hyperkalemia	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypermagnesemia	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypernatremia	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypertriglyceridemia	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypokalemia	29.7% 11/37 • Number of events 41 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypomagnesemia	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hyponatremia	48.6% 18/37 • Number of events 48 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Metabolism and nutrition disorders Hypophosphatemia	8.1% 3/37 • Number of events 7 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Musculoskeletal and connective tissue disorders Arthralgia	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Musculoskeletal and connective tissue disorders Chest wall pain	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Nervous system disorders Intracranial hemorrhage	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Nervous system disorders Syncope	5.4% 2/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Renal and urinary disorders Proteinuria	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.7% 1/37 • Number of events 2 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.4% 2/37 • Number of events 3 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Respiratory, thoracic and mediastinal disorders Pneumonitis	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Vascular disorders Hypertension	8.1% 3/37 • Number of events 4 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Vascular disorders Hypotension	8.1% 3/37 • Number of events 4 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	2.7% 1/37 • Number of events 1 • Adverse Events (AEs) were collected for 30 days after completion of treatment plan or until other anti-leukemia therapy was initiated. If discontinuation from study was due to an AE considered related to study treatment, a follow-up visit was conducted no later than 30 days after the last dose of protocol therapy with recommended safety assessments at least every 30 days, until all toxicities resolved, returned to baseline or became clinically satisfactory, stable, or considered irreversible.

Additional Information

Jeffrey E. Rubnitz, MD, PhD

St. Jude Children's Research Hospital

Phone: 901-595-2388

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place