← Back to Search

Enzyme

IM JZP-458 for Lymphoblastic Leukemia

Phase 2 & 3
Waitlist Available
Research Sponsored by Jazz Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pediatric and adult patients with a diagnosis of ALL or LBL.
Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 30 days (ada- samples) after last dose of last course and up to 6 months (ada+ samples) after last dose of last course, up to approximately 2 years 7 months
Awards & highlights

Study Summary

This trial is testing a new asparaginase drug for people with leukemia who are allergic to current asparaginase drugs. The new drug will be tested for safety, tolerability, and efficacy.

Eligible Conditions
  • Lymphoblastic Leukemia
  • Acute Lymphoblastic Leukemia

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 30 days (ada- samples) after last dose of last course and up to 6 months (ada+ samples) after last dose of last course, up to approximately 2 years 7 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 30 days (ada- samples) after last dose of last course and up to 6 months (ada+ samples) after last dose of last course, up to approximately 2 years 7 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Response Rate During the First Course of JZP-458 Administration
Secondary outcome measures
Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration
Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458
Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration
+1 more

Side effects data

From 2022 Phase 2 & 3 trial • 229 Patients • NCT04145531
42%
Neutrophil count decreased
39%
Anaemia
39%
Platelet count decreased
36%
Vomiting
36%
White blood cell count decreased
36%
Headache
30%
Fatigue
27%
Back pain
27%
Febrile neutropenia
24%
Lymphocyte count decreased
24%
Pain in extremity
24%
Pyrexia
24%
Nausea
21%
Decreased appetite
21%
Hyperglycaemia
18%
Stomatitis
18%
Alanine aminotransferase increased
15%
Cough
15%
Aspartate aminotransferase increased
15%
Arthralgia
15%
Abdominal pain
15%
Sinus tachycardia
15%
Insomnia
12%
Diarrhoea
12%
Gastrooesophageal reflux
12%
Contusion
12%
Hypocalcaemia
12%
Alopecia
12%
Pain
12%
Hypoalbuminaemia
12%
Constipation
12%
Blood cholesterol increased
12%
Flushing
12%
Rhinorrhoea
9%
Muscular weakness
9%
Hypokalaemia
9%
Irritability
9%
Hypoglycaemia
9%
Blood fibrinogen decreased
9%
Hypertriglyceridaemia
9%
Agitation
9%
Upper respiratory tract infection
9%
Dehydration
9%
Oral pain
9%
Injection site pain
9%
Abdominal pain upper
9%
Paraesthesia
6%
Drug hypersensitivity
6%
Blood bilirubin increased
6%
Sinus bradycardia
6%
Periorbital oedema
6%
Enterocolitis infectious
6%
Arthropod bite
6%
Paronychia
6%
CD4 lymphocytes decreased
6%
Haematocrit decreased
6%
Haemoglobin decreased
6%
Weight increased
6%
Dizziness
6%
Bone pain
6%
Oropharyngeal pain
6%
Myalgia
6%
Dyspnoea
6%
Vision blurred
6%
Epistaxis
6%
Corona virus infection
6%
Hyperphosphataemia
6%
Pruritis
6%
Musculoskeletal pain
6%
Pain in jaw
6%
Asthenia
6%
Mood swings
6%
Muscle spasms
6%
Peripheral motor neuropathy
6%
Sepsis
6%
Toothache
6%
Hypermagnesemia
6%
Hyponatraemia
6%
Peripheral sensory neuropathy
6%
Anxiety
6%
Rash maculo-papular
3%
Chills
3%
Dyspepsia
3%
Rash
3%
Dysuria
3%
Wound infection
3%
Osteonecrosis
3%
Hypotension
3%
Activated partial thromboplastin time prolonged
3%
Weight decreased
3%
Dermatitis diaper
3%
Cerebrospinal fluid leakage
3%
Dry skin
3%
Hypertension
3%
Nasal congestion
3%
Hypoxia
3%
Toxicity to various agents
3%
Acute respiratory distress syndrome
3%
Dermatitis contact
3%
Leukoencephalopathy
3%
Depression
3%
Acidosis
3%
Soft tissue infection
3%
Cardiac failure
3%
Colitis
3%
Methaemoglobinaemia
3%
Tachycardia
3%
Thrombocytopenia
3%
Respiratory failure
3%
Necrotising fasciitis
3%
Febrile Neutropenia
3%
Skin infection
3%
Blood alkaline phosphatase increased
3%
Acute kidney injury
3%
Presyncope
3%
Anal fissure
3%
Hypophosphataemia
3%
Neuropathy peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part A: JZP-458 IM 25 mg/m^2 (MWF)
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

Trial Design

1Treatment groups
Experimental Treatment
Group I: JZP-458Experimental Treatment2 Interventions
Part A (IM JZP-458) of the study will have 2 IM cohorts: Cohort 1: a JZP-458 repeat dose/confirmatory cohort; a final IM JZP-458 dose level will be selected, and Cohort 2: an expansion cohort to confirm the efficacy and safety of the final IM JZP-458 dose level and schedule Part B (IV JZP-458 Dose Confirmation) will be conducted to define the optimal dose of the IV administration of JZP-458 for further study in ALL/LBL patients as a repeated dose. Additional courses of JZP-458 (IM or IV depending on patient's allocation at study enrollment) will be administered based on each patient's original treatment plan for as long as the patient derives clinical benefit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IM JZP-458
2019
Completed Phase 3
~230
IV JZP-458
2019
Completed Phase 3
~230

Find a Location

Who is running the clinical trial?

Jazz PharmaceuticalsLead Sponsor
248 Previous Clinical Trials
34,130 Total Patients Enrolled
Children's Oncology Group (COG)UNKNOWN
1 Previous Clinical Trials
128 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~44 spots leftby Mar 2025