Asparaginase Erwinia Chrysanthemi + Chemotherapy for Blood Cancer

Recruiting at 7 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Asparaginase, Live vaccines

Disqualifiers: Ph+, CNS involvement, cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

53 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of asparaginase Erwinia chrysanthemi, an enzyme used in chemotherapy, combined with chemotherapy for treating adults with newly diagnosed high-risk acute lymphoblastic leukemia or lymphoblastic lymphoma. The drug breaks down an amino acid that cancer cells need to grow. This trial may suit adults recently diagnosed with these blood cancers who cannot take the usual form of asparaginase derived from E. coli. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like live vaccines are not allowed during the study, and some medications may need to be adjusted. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Earlier studies have shown that asparaginase Erwinia chrysanthemi is safe for patients with acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). This medication is often used for individuals who have allergic reactions to a similar enzyme from another source. Research indicates that it is well-tolerated, particularly for those who cannot use the standard version due to allergies.

While some side effects may occur, as with most cancer treatments, they are usually manageable. These studies provide strong evidence for its continued use in clinical trials to further understand its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blood cancer?

Asparaginase Erwinia chrysanthemi is unique because it offers a new approach to treating blood cancer, distinct from the more common treatments like asparaginase derived from E. coli. This alternative enzyme is derived from a different bacterial source, which may be tolerated better by patients who develop allergies to the standard E. coli-derived asparaginase. Researchers are excited about this option because it could provide an effective treatment for patients who otherwise have limited options due to allergic reactions, potentially improving outcomes and expanding treatment availability.

What evidence suggests that this trial's treatments could be effective for blood cancer?

Research has shown that asparaginase Erwinia chrysanthemi, which participants in this trial may receive, effectively treats acute lymphoblastic leukemia (ALL). Studies have demonstrated its ability to break down asparagine, a substance cancer cells need to grow. This action helps stop cancer cells from growing and may even kill them. Previous research indicates that this drug is as safe as other similar treatments for ALL. Patients who received this treatment responded well, making it a viable option for those unable to use the E. coli-derived version. ^{6 7 8 9 10}

Who Is on the Research Team?

Ibrahim Aldoss

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

Adults newly diagnosed with high-risk acute lymphoblastic leukemia or lymphoblastic lymphoma are eligible for this trial. The study is designed for those who can't take the E. coli-derived asparaginase and need an alternative treatment.

Inclusion Criteria

Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)

My heart's pumping ability is normal.

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I haven't had a heart attack or unstable angina in the last 6 months.

I have another active cancer besides the one being treated.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Patients receive induction therapy with cytarabine, dexamethasone, vincristine, daunorubicin, asparaginase Erwinia chrysanthemi, and methotrexate. CD20 positive patients also receive rituximab.

4 weeks

Weekly visits for drug administration

Extended Induction

Patients with M2 marrow receive extended induction therapy with dexamethasone, vincristine, daunorubicin, and asparaginase Erwinia chrysanthemi.

2 weeks

Consolidation

Patients receive consolidation therapy with cyclophosphamide, cytarabine, mercaptopurine, vincristine, methotrexate, and rituximab for CD20 positive patients.

8 weeks

Bi-weekly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Asparaginase Erwinia chrysanthemi
• Cyclophosphamide
• Cytarabine
• Daunorubicin Hydrochloride
• Dexamethasone
• Mercaptopurine
• Methotrexate
• Rituximab
• Vincristine Sulfate

Trial Overview The trial tests asparaginase Erwinia chrysanthemi combined with induction chemotherapy (cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, rituximab), followed by consolidation therapy to kill any remaining cancer cells.

How Is the Trial Designed?

Group I: Treatment (asparaginase Erwinia chrysanthemi) Experimental Treatment 16 Interventions

See Detailed Description

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36108304/

results from the phase 2/3 AALL1931 study Results demonstrate that IM JZP458 at 25/25/50 mg/m2 MWF is efficacious and has a safety profile consistent with other asparaginases.

2. haematologica.org haematologica.org/article/view/11165

the amazing journey of the therapeutic anti-leukemia ... In 2023, Maese et al. reported that this recombinant Erwinia c. ASNase was efficacious at 25/25/50 mg/m when given IM on a MondayWednesday- ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07133997

Recombinant Erwinia Asparaginase and Venetoclax in ... Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It ...

4. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/1498/501397/Efficacy-and-Safety-of-Recombinant-Erwinia

Efficacy and Safety of Recombinant Erwinia Asparaginase ... Treatment-related adverse events (TRAEs) ≥ grade 3 occurred in 126/228 (55%) patients; but no TRAE led to death. Table 2 shows the most commonly ...

5. aetna.com aetna.com/cpb/medical/data/800_899/0864.html

Asparaginase Erwinia Chrysanthemi (Recombinant)-rywn ... Emadi et al (2014) stated that asparaginases are among the most effective agents against acute lymphoblastic leukemia (ALL) and are Food and Drug Administration ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24436152/

Safety profile of asparaginase Erwinia chrysanthemi in a ... This study further established the safety profile of asparaginase Erwinia chrysanthemi in patients with ALL or LBL who had a hypersensitivity reaction.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pbc.24938

Safety profile of asparaginase Erwinia chrysanthemi in a ... Background. L-Asparaginase is an integral component of standard chemotherapy regimens for the treatment of acute lymphoblastic leukemia (ALL).

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06918431

NCT06918431 | Asparaginase Erwinia Chrysanthemi With ... This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by ...

9. ashpublications.org ashpublications.org/bloodadvances/article/9/1/66/525802/Recombinant-Erwinia-asparaginase-JZP458-in-ALL-LBL

Recombinant Erwinia asparaginase (JZP458) in ALL/LBL Safety profile of asparaginase Erwinia chrysanthemi in a large compassionate-use trial . Pediatr Blood Cancer . 2014. ;. 61. (. 7. ): 1232. -.

10. sciencedirect.com sciencedirect.com/science/article/pii/S0006497123081016

Efficacy and Safety of Recombinant Erwinia Asparaginase ... It is used in treatment of patients with acute lymphoblastic leukemia/lymphoblastic lymphoma who developed hypersensitivity/silent inactivation to Escherichia ...