NCT06918431 · City of Hope Medical Center
Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Asparaginase Erwinia chrysanthemi
Given IM
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
PROCEDURE
Bone Marrow Aspiration
Undergo bone marrow aspiration and/or biopsy
PROCEDURE
Bone Marrow Biopsy
Undergo bone marrow aspiration and/or biopsy
PROCEDURE
Computed Tomography
Undergo CT or PET/CT
DRUG
Cyclophosphamide
Given IV
DRUG
Cytarabine
Given IT
DRUG
Cytarabine
Given IV or SC
DRUG
Daunorubicin Hydrochloride
Given IV
DRUG
Dexamethasone
Given PO
PROCEDURE
Echocardiography
Undergo echocardiography
PROCEDURE
Lumbar Puncture
Undergo lumbar puncture
DRUG
Mercaptopurine
Given PO
DRUG
Methotrexate
Given IT
PROCEDURE
Positron Emission Tomography
Undergo PET/CT
BIOLOGICAL
Rituximab
Given IV
DRUG
Vincristine Sulfate
Given IV
Primary outcome measures
Incidence of adverse events (AEs) (Safety Lead-in)
Time frame: Up to completion of induction cycle (cycle length = 28 days)
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.
Incidence of unacceptable adverse events (Safety Lead-in)
Time frame: Up to completion of induction cycle 1 (cycle length = 28 days)
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.
Incidence of grade 3 or higher hepatotoxicity and not resolved to grade 1 or lower within 14 days of occurrence (Expansion)
Time frame: Up to completion of induction (cycle length = 28 days)
Will be graded using NCI CTCAE 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. The overall rate and its 95% Clopper Pearson binomial confidence interval (CI) will be estimated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Documented informed consent of the participant and/or legally authorized representative
- Age between 18 and 39 with body mass index (BMI) ≥ 30 or age 40-54 years, regardless of BMI
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Patients with newly diagnosed Philadelphia (Ph)-negative (-) acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL) according to World Health Organization (WHO) criteria
- Both B- and T-cell phenotypes are allowed.
- CD20+ patients only: White blood cell count less than 25 x 10\^9/L prior to initiation of rituximab (within 14 days prior to day 1 of protocol therapy)
- Cytoreduction with hydroxyurea or steroid or a single dose of intrathecal chemotherapy prior to treatment may be required
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy) (unless has Gilbert's disease or related to underlying leukemia, ≤ 3 x ULN)
- Aspartate aminotransferase (AST) ≤ 3.0 x ULN (AST
Where
- Phoenix, Arizona
- Duarte, California
- Irvine, California
- La Jolla, California
- Los Angeles, California
- Chicago, Illinois
- New York, New York
- Cleveland, Ohio
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 17, 2026 · Source of record for eligibility and locations