Trial · NCT04145531
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
NCT04145531, Phase 2, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2023-11-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL). Trials, record NCT04145531. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04145531
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)
- NCT number
- NCT04145531
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 229 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Acute Lymphoblastic Leukemia, Lymphoblastic Leukemia
- Interventions
- IM JZP-458, IV JZP-458
- First posted
- 2019-10-30
- Last updated
- 2023-11-18
- Results first posted
- 2023-11-18
- Limitations and caveats
- Participants in this study received JZP-458 as part of a multi-agent chemotherapeutic regimen.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response Rate During the First Course of JZP-458 Administration | Baseline up to 2 weeks | The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination. |
| Primary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not considered related to study drug. AEs were classified by the Investigator using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. |
| Secondary | Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Baseline up to 2 weeks | Blood samples were collected for serum asparaginase activity level determination. |
| Secondary | Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Baseline up to 2 weeks | Blood samples were collected for serum asparaginase activity level determination. |
| Secondary | Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration | Up to 2 weeks (6 doses) | Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported. |
| Secondary | Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458 | 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 | Blood samples were collected for immunogenicity analysis. Anti-drug antibody positive (ADA+) participants were those with a positive result on the first test and also a positive result on the confirmatory test. Anti-drug antibody negative (ADA-) participants had a negative result on the first test. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response Rate During the First Course of JZP-458 Administration | Baseline up to 2 weeks | Response rates were assessed in the Efficacy Analysis Set in participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Date of written informed consent up to 30 days after last dose of last course, up to approximately 2 years 7 months | Safety events were assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Baseline up to 2 weeks | Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Last NSAA Levels ≥ 0.4 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Baseline up to 2 weeks | Nadir serum asparaginase activity levels were assessed in the Efficacy Analysis Set in participants with available data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration | Up to 2 weeks (6 doses) | Serum asparaginase activity levels were assessed in participants with available data in the Efficacy Analysis Set. | IU/mL | MEAN |
| SECONDARY | Number of Participants Who Are Anti-drug Antibody Positive or Negative Against JZP-458 | 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 | Immunogenicity was assessed in the Safety Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Response Rate During the First Course of JZP-458 Administration | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 18 | Participants | ||
| Response Rate During the First Course of JZP-458 Administration | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 70 | Participants | ||
| Response Rate During the First Course of JZP-458 Administration | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 44 | Participants | ||
| Response Rate During the First Course of JZP-458 Administration | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 20 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 32 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 49 | Participants | ||
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 60 | Participants | ||
| Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 31 | Participants | ||
| Number of Participants With Last 48-hour NSAA Level ≥ 0.1 IU/mL During The First Course (6 Doses) of JZP-458 Administration | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 82 | Participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 33 | |
| Part A | STARTED | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 | |
| Part A | STARTED | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 51 | |
| Part A | STARTED | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 0 | |
| Part A | Safety Analysis Set | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 33 | |
| Part A | Safety Analysis Set | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 | |
| Part A | Safety Analysis Set | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 51 | |
| Part A | Safety Analysis Set | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 0 | |
| Part A | Efficacy Analysis Set | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 32 | |
| Part A | Efficacy Analysis Set | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 83 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events948
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 13 | 33 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 47 | 83 | |
| other | Anaemia | Blood and lymphatic system disorders | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 28 | 51 | |
| other | Anaemia | Blood and lymphatic system disorders | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 22 | 61 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 1 | 33 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 5 | 83 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 2 | 51 | |
| other | Febrile Neutropenia | Blood and lymphatic system disorders | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 0 | 61 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 1 | 33 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 1 | 83 |
1 to 10 of 948Source ClinicalTrials.gov
See all 948 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 1 | 33 |
| Total, all-cause mortality | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 2 | 83 |
| Total, all-cause mortality | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 0 | 51 |
| Total, all-cause mortality | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 0 | 61 |
| Total, other adverse events | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 31 | 33 |
| Total, other adverse events | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 81 | 83 |
| Total, other adverse events | Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F) | 48 | 51 |
| Total, other adverse events | Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F) | 56 | 61 |
| Total, serious adverse events | Part A: JZP-458 IM 25 mg/m^2 (MWF) | 20 | 33 |
| Total, serious adverse events | Part A: JZP-458 IM 37.5 mg/m^2 (MWF) | 57 | 83 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04145531
GET https://conductscience.org/api/trials/v1/NCT04145531/results?page=2