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NCT06918431 · ClinicalTrials.gov registry record · Phase 2
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
A Phase 2 study of Lymphoblastic Lymphoma and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, sponsored by City of Hope Medical Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
- 8
- Study locations
NCT06918431: Recruiting Phase 2 study of Lymphoblastic Lymphoma and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, sponsored by City of Hope Medical Center.
NCT06918431 is a Phase 2 study of Lymphoblastic Lymphoma and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative that is actively recruiting participants, run by City of Hope Medical Center. The registered enrollment target is 53 participants, below the 190-participant average among 21 other Lymphoblastic Lymphoma trials with a reported enrollment target (72% lower). The trial reports 8 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06918431, a Phase 2 study of Lymphoblastic Lymphoma and B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative, is actively recruiting participants, sponsored by City of Hope Medical Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
- 8
- Study locations
Study Summary
This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwinia chrysanthemi, a type of protein synthesis inhibitor, is a drug that is made up of the enzyme asparaginase, which comes from the bacterium Erwinia chrysanthemi, and is used with other drugs in people who cannot take asparaginase that comes from the bacterium E. coli. Asparaginase Erwinia chrysanthemi breaks down the amino acid asparagine and may stop the growth of cancer cells that need asparagine to grow. It may also kill cancer cells. Induction therapy, consisting of cytarabine, dexamethasone, vincristine, daunorubicin, methotrexate, and rituximab, is the first choice of treatment. Consolidation therapy, consisting of cyclophosphamide, cytarabine, vincristine, mercaptopurine, methotrexate and rituximab, is given after initial therapy to kill any remaining cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Cytarabine and mercaptopurine stop cells from making DNA and may kill cancer cells. They are a type of antimetabolite. Daunorubicin blocks a certain enzyme needed for cell d
Primary Outcome
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Will be summarized for evaluable patients in terms of type (organ affected or laboratory determination), severity, time of onset, duration, frequency, probable association with the study treatment and reversibility or outcome.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Asparaginase Erwinia chrysanthemi
Study Locations (8)
California
- City of Hope Medical Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- UC San Diego Moores Cancer Center - La Jolla
- UCLA / Jonsson Comprehensive Cancer Center - Los Angeles
Arizona
- City of Hope at Phoenix - Phoenix
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2025-10-10 |
| Est. Completion | 2029-03-30 |
| Phase | Phase 2 |
What NCT06918431 shows while recruiting
NCT06918431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 190-participant average among 21 other Lymphoblastic Lymphoma trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Lymphoblastic Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06918431 lists 8 locations in 5 states (California, Arizona, Illinois).
Frequently Asked Questions
What is clinical trial NCT06918431 about?
NCT06918431 is a clinical study titled "Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma". This phase II trial tests the safety, side effects, and effectiveness of asparaginase Erwinia chrysanthemi during induction chemotherapy followed by consolidation chemotherapy in treating high-risk adults with newly diagnosed acute lymphoblastic leukemia or lymphoblastic lymphoma. Asparaginase Erwin...
What is the current status of trial NCT06918431?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2025-10-10. Estimated completion is 2029-03-30.
What conditions does trial NCT06918431 study?
This clinical trial studies the following conditions: Lymphoblastic Lymphoma, B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative.
What interventions are being tested in trial NCT06918431?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Asparaginase Erwinia chrysanthemi (DRUG).
Who is sponsoring clinical trial NCT06918431?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06918431 being conducted?
This trial has 8 study locations across Arizona, California, Illinois, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06918431's enrollment target sits among peer trials
53 15th of 21 higher than 7 of 21 other Lymphoblastic Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoblastic Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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