Acute Lymphoblastic LeukemiaNCT04943952
JZP458 - Recombinant Erwinia Asparaginase for Treatment of ALL / LBL Patients With Hypersensitivity to E. Coli-derived Asparaginase
A study testing Asparaginase Erwinia Chrysanthemi (recombinant) in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals.
Trial summary
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
- What is being tested?
- Asparaginase Erwinia Chrysanthemi (recombinant)
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Patient (or parent/legally authorized representative thereof) is able to understand and voluntarily give informed consent/assent
- Patient has a diagnosis of ALL or LBL
- Patient received appropriate standard treatment without success (or no standard treatment exists for the patient's condition), and no satisfactory alternative drug is available
- Patient had a ≥ Grade 2 allergic reaction (Common Terminology Criteria for Adverse Events [CTCAE] v5.0) to a long-acting E. coli-derived asparaginase OR have silent inactivation
- Patient, in Investigators' opinion, has fully recovered from their prior allergic reaction to E. coli-derived asparaginase Note: Patients must have completed antihistamine, epinephrine, and/or corticosteroid treatment for the allergic reaction ≥ 24 hours prior to JZP458 administration.
- Patient has adequate liver function, defined as: direct (conjugated) bilirubin ≤ 3X upper limit of normal (ULN); serum glutamic pyruvic transaminase (SGPT)(alanine aminotransferase [ALT]), and serum glutamic-oxaloacetic transaminase (SGOT)(aspartate transaminase [AST]) ≤ 5X ULN
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- For female patients of childbearing potential (i.e., fertile, following menarche) and male patients who have female partners of childbearing potential:
- Patient has agreed to use medically acceptable methods of contraception with their partners for the duration of treatment with JZP458 and for 30 days after the last dose of JZP458.
- Medically acceptable methods of contraception that the patient may use include abstinence, progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action; a combination of male condoms with either cap, diaphragm, or sponge with spermicide (double barrier methods).
Who cannot join
- Patient is currently taking part in or is eligible for a clinical trial for JZP458
- Patient previously received asparaginase Erwinia Chrysanthemi AND has access to a short-acting non-E. Coliasparaginase
- Patient experienced concern of a possible adverse event (AE) related to asparaginase Erwinia Chrysanthemi
- Patient to receive asparaginase Erwinia Chrysanthemi within 1 week of plans to start JZP458
- Patient is concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP458(within 48 hours)
- Patient has a history of ≥ Grade 3 pancreatitis (per CTCAE v5.0)
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- Patient has a history of ≥ Grade 3 hypersensitivity to asparaginase Erwinia Chrysanthemi
- Patient has a prior history of asparaginase-associated ≥ Grade 3 (per CTCAE v5.0) haemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events
- Female patients who are lactating and do not agree to stop breast-feeding
- Eligibility Criteria (Re-Supply Requests)
- Patient remains eligible for inclusion in the Expanded Access Protocol (EAP)
- Patient continues to benefit from treatment with JZP458
- Patient has not encountered unacceptable toxicity
- Patient has not shown signs/symptoms of relapsed or refractory disease
- Patient has not encountered ≥ Grade 3hypersensitivity symptoms
- Patient is not pregnant or breastfeeding
About this study
Official title: JZP458 -Asparaginase Erwinia Chrysanthemi (Recombinant) for the Treatment of Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LBL) in Adult and Pediatric Patients Who Have Developed Hypersensitivity or Silent Inactivation to E. Coli-derived Asparaginase
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.
Read the detailed description
JZP458 is a recombinant Erwinia asparaginase that utilizes a novel Pseudomonas fluorescent technology expression platform to produce an enzyme with no immunologic cross-reactivity to E.coli-derived asparaginases. JZP458 is currently being studied in an open-label, multicenter, dose confirmation, and Pharmacokinetic (PK) study of JZP458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess tolerability and efficacy by measuring asparaginase activity. For the EAP, JZP458 will be provided free of charge by the Sponsor for the duration of the program. In addition, JZP458 will continue to be provided to eligible patients at referring sites until it becomes commercially available in the US.
JZP458 will be administered per each patient's original treatment plan, as long as the patient derives clinical benefit.
- Being tested
- Asparaginase Erwinia Chrysanthemi (recombinant)
- Keywords
- JZP458, Asparaginase Erwinia Chrysanthemi (Recombinant), Recombinant Erwinia Asparaginase, RC-P
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asparaginase Erwinia Chrysanthemi (recombinant)Drug
Also called JZP458, RC-P
Participants will receive JZP458 via intramuscular injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Jazz PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jazz Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943952
- Sponsor's protocol ID
- JZP458-701-01
- Status last verified
- Jul 2021
- First submitted
- 21 Jun 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JZP458 -Asparaginase Erwinia Chrysanthemi (Recombinant) for the Treatment of Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LBL) in Adult and Pediatric Patients Who Have Developed Hypersensitivity or Silent Inactivation to E. Coli-derived Asparaginase
- ClinicalTrials.gov ID
- NCT04943952
- Acronym / sponsor ID
- JZP458-701-01
- Keywords
- JZP458, Asparaginase Erwinia Chrysanthemi (Recombinant), Recombinant Erwinia Asparaginase, RC-P
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Jazz PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an Expanded Access Protocol (EAP) of JZP458 in participants with ALL/LBL who are hypersensitive to an E.coli-derived asparaginase (allergic reaction or silent inactivation) and unable to access alternative licensed treatment, to receive JZP458 treatment prior to potential Food and Drug Administration (FDA) approval and commercial availability.
Detailed description
JZP458 is a recombinant Erwinia asparaginase that utilizes a novel Pseudomonas fluorescent technology expression platform to produce an enzyme with no immunologic cross-reactivity to E.coli-derived asparaginases. JZP458 is currently being studied in an open-label, multicenter, dose confirmation, and Pharmacokinetic (PK) study of JZP458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess tolerability and efficacy by measuring asparaginase activity. For the EAP, JZP458 will be provided free of charge by the Sponsor for the duration of the program. In addition, JZP458 will continue to be provided to eligible patients at referring sites until it becomes commercially available in the US.
JZP458 will be administered per each patient's original treatment plan, as long as the patient derives clinical benefit.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patient (or parent/legally authorized representative thereof) is able to understand and voluntarily give informed consent/assent
- Patient has a diagnosis of ALL or LBL
- Patient received appropriate standard treatment without success (or no standard treatment exists for the patient's condition), and no satisfactory alternative drug is available
- Patient had a ≥ Grade 2 allergic reaction (Common Terminology Criteria for Adverse Events [CTCAE] v5.0) to a long-acting E. coli-derived asparaginase OR have silent inactivation
- Patient, in Investigators' opinion, has fully recovered from their prior allergic reaction to E. coli-derived asparaginase Note: Patients must have completed antihistamine, epinephrine, and/or corticosteroid treatment for the allergic reaction ≥ 24 hours prior to JZP458 administration.
Key exclusion criteria (16 listed)
- Patient is currently taking part in or is eligible for a clinical trial for JZP458
- Patient previously received asparaginase Erwinia Chrysanthemi AND has access to a short-acting non-E. Coliasparaginase
- Patient experienced concern of a possible adverse event (AE) related to asparaginase Erwinia Chrysanthemi
- Patient to receive asparaginase Erwinia Chrysanthemi within 1 week of plans to start JZP458
- Patient is concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP458(within 48 hours)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Asparaginase Erwinia Chrysanthemi (recombinant)Also: JZP458, RC-PParticipants will receive JZP458 via intramuscular injection. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Asparaginase Erwinia Chrysanthemi (recombinant) in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by Jazz Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.