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NEDD8-activating enzyme inhibitor

Pevonedistat for Acute Lymphoblastic Leukemia

Phase 1
Waitlist Available
Research Sponsored by Julio Barredo, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from cycle 1 day 1 to up to 30 days post last dose of protocol therapy, about 90 days
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it can help people with a certain kind of leukemia who have relapsed or don't respond to other treatments.

Eligible Conditions
  • Acute Lymphoblastic Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from cycle 1 day 1 to up to 30 days post last dose of protocol therapy, about 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and from cycle 1 day 1 to up to 30 days post last dose of protocol therapy, about 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of the Maximum Tolerated Dose (MTD) in Study Participants Receiving Protocol Therapy
Rate of Toxicity in Study Participants Receiving Protocol Therapy
Secondary outcome measures
Pharmacodynamics (PD): Expression Levels of Endoplasmic Reticulum (ER) Stress Response and Unfolded Protein Response (UPR) in Primary ALL Cells to Pevonedistat Therapy
Pharmacokinetics (PK): Area Under the Curve (AUC) of Plasma Concentration of Pevonedistat
Pharmacokinetics (PK): Maximum (Peak) Plasma Concentration (Cmax) of Pevonedistat
+3 more

Side effects data

From 2021 Phase 2 trial • 120 Patients • NCT02610777
47%
Constipation
45%
Nausea
44%
Anaemia
40%
Fatigue
35%
Pyrexia
34%
Cough
34%
Neutropenia
27%
Diarrhoea
26%
Dyspnoea
24%
Febrile neutropenia
24%
Thrombocytopenia
21%
Decreased appetite
21%
Asthenia
21%
Vomiting
19%
Arthralgia
18%
Hypokalaemia
16%
Abdominal pain
15%
Oedema peripheral
15%
Dizziness
13%
Pneumonia
13%
Back pain
13%
Headache
13%
Pruritus
11%
Platelet count decreased
11%
Bronchitis
11%
Injection site pain
11%
Insomnia
11%
Chills
10%
Epistaxis
10%
Fall
10%
Neutrophil count decreased
10%
Oral herpes
10%
Oropharyngeal pain
10%
White blood cell count decreased
8%
Erythema
8%
Aspartate aminotransferase increased
8%
Hypomagnesaemia
8%
Muscular weakness
8%
Stomatitis
8%
Urinary tract infection
8%
Weight decreased
8%
Pleural effusion
6%
Dehydration
6%
Musculoskeletal pain
6%
Hypophosphataemia
6%
Contusion
6%
Pain in extremity
6%
Productive cough
6%
Non-cardiac chest pain Pain
6%
Sepsis
6%
Alanine aminotransferase increased
6%
Hypoalbuminaemia
6%
Hypocalcaemia
6%
Hyponatraemia
6%
Malaise
6%
Nasal congestion
6%
Non-cardiac chest pain
6%
Oral candidiasis
6%
Petechiae
6%
Nasopharyngitis
3%
Cellulitis
3%
Cerebrovascular accident
3%
Gastric haemorrhage
2%
Atrial fibrillation
2%
Congestive cardiomyopathy
2%
Acute febrile neutrophilic dermatosis
2%
Embolic stroke
2%
Endocarditis
2%
Failure to thrive
2%
Gastrointestinal necrosis
2%
Hepatic lesion
2%
Lower respiratory tract infection
2%
Lung infiltration
2%
Multiple organ dysfunction syndrome
2%
Myocardial infarction
2%
Wound infection
2%
Postoperative hypotension
2%
Acute myeloid leukaemia
2%
Ankle fracture
2%
Arthritis
2%
Arthritis reactive
2%
Autoimmune haemolytic anaemia
2%
Bacteraemia
2%
Bacterial sepsis
2%
Bronchopulmonary aspergillosis
2%
Cauda equina syndrome
2%
Cholecystitis
2%
Drug hypersensitivity
2%
Gastrointestinal ulcer perforation
2%
Haematuria
2%
Haemorrhage intracranial
2%
Hypoxia
2%
Influenza
2%
Inguinal hernia
2%
Ischaemic gastritis
2%
Leukopenia
2%
Myelodysplastic syndrome
2%
Myelodysplastic syndrome transformation
2%
Post procedural hypotension
2%
Rectal haemorrhage
2%
Renal colic
2%
Respiratory tract infection
2%
Soft tissue infection
2%
Spinal compression fracture
2%
Urinary tract infection enterococcal
2%
Urinary tract obstruction
2%
Lung infection
2%
Chronic kidney disease
2%
Death
2%
Gastritis erosive
2%
Supraventricular tachycardia
2%
Thrombophlebitis superficial
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azacitidine 75 mg/m^2
Azacitidine 75 mg/m^2 + Pevonedistat 20 mg/m^2

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Dose Level 1: Pevonedistat 15 + VXLDExperimental Treatment8 Interventions
Pevonedistat: 15 mg/m2 intravenously (IV) Vincristine: 1.5 mg/m2/dose IV push Dexamethasone: 10 mg/m2/day divided twice daily PEG-asparaginase: 2000 IU's/m2/day, capped at maximal dose of 3750 IU's. Doxorubicin: 60 mg/m2/day IV Intrathecal (IT) chemotherapy via injection per protocol: All subjects: Cytarabine 70 mg ; For central nervous system (CNS) negative subjects: Methotrexate 15 mg; For CNS positive subjects (Triple IT Therapy): Cytarabine 30 mg, Methotrexate 15 mg, and Hydrocortisone 15 mg.
Group II: Dose Level 2: Pevonedistat 20 + VXLDActive Control8 Interventions
Pevonedistat: 20 mg/m2 IV Vincristine: 1.5 mg/m2/dose IV push Dexamethasone: 10 mg/m2/day divided twice daily PEG-asparaginase: 2000 IU's/m2/day, capped at maximal dose of 3750 IU's. Doxorubicin: 60 mg/m2/day IV Intrathecal (IT) chemotherapy via injection per protocol: All subjects: Cytarabine 70 mg ; For CNS negative subjects: Methotrexate 15 mg; For CNS positive subjects (Triple IT Therapy): Cytarabine 30 mg, Methotrexate 15 mg, and Hydrocortisone 15 mg.
Group III: Dose Level -1: Pevonedistat 10 + VXLDActive Control8 Interventions
Pevonedistat: 10 mg/m2 IV Vincristine: 1.5 mg/m2/dose IV push Dexamethasone: 10 mg/m2/day divided twice daily PEG-asparaginase: 2000 IU's/m2/day, capped at maximal dose of 3750 IU's. Doxorubicin: 60 mg/m2/day IV Intrathecal (IT) chemotherapy via injection per protocol: All subjects: Cytarabine 70 mg ; For CNS negative subjects: Methotrexate 15 mg; For CNS positive subjects (Triple IT Therapy): Cytarabine 30 mg, Methotrexate 15 mg, and Hydrocortisone 15 mg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine
2003
Completed Phase 4
~2910
PEG-asparaginase
2006
Completed Phase 3
~340
Dexamethasone
2007
Completed Phase 4
~2590
Pevonedistat
2021
Completed Phase 2
~290
Methotrexate
2013
Completed Phase 4
~3800
Doxorubicin
2012
Completed Phase 3
~7940
Cytarabine
2016
Completed Phase 3
~3310
Hydrocortisone
2005
Completed Phase 4
~1260

Find a Location

Who is running the clinical trial?

Julio Barredo, MDLead Sponsor
TakedaIndustry Sponsor
1,202 Previous Clinical Trials
4,178,010 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL
Julio Barredo, MD 2019. "Pevonedistat With VXLD Chemotherapy for Adolescent/Young Adults With Relapsed/Refractory ALL or Lymphoblastic NHL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03349281.
~1 spots leftby Apr 2025
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