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New treatment option for B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative
Official title Asparaginase Erwinia Chrysanthemi With Chemotherapy for the Treatment of High-Risk Adults With Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
ClinicalTrials.gov ID: NCT06918431
What this study is testing
What is Asparaginase Erwinia chrysanthemi?
Asparaginase Erwinia chrysanthemi is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for b acute lymphoblastic leukemia, philadelphia chromosome negative.
Also referred to as Asparaginase Erwinia chrysanthemi (Recombinant)-rywn, Asparaginase Erwinia chrysanthemi, Recombinant-rywn.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 54
You may be able to join if
- 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...
- Both B- and T-cell phenotypes are allowed.
You likely can't join if
- Leukemia-based therapy with chemotherapy with the exception of:
- Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
- Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
- Received previous treatment with any other asparaginase formulation
- Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+...
- Known presence of Philadelphia chromosome positive (Ph+; t[9;22])
See the full eligibility 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 ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
- Note: AST ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
- Alanine aminotransferase (ALT) ≤ 3.0 x ULN (ALT ≤ 5.0 x ULN if related to underlying leukemia) (within 14 days prior to day 1 of protocol therapy)
- Note: ALT ≤ 3.0 x ULN at the time of first dose of recombinant Erwinia asparaginase administration
- Creatinine clearance of ≥ 60 mL/min per 24-hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)
- Prothrombin (PT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
- Activated partial thromboplastin time (aPTT) ≤ 1.5 ULN (within 14 days prior to day 1 of protocol therapy)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Note: Echocardiogram to be performed within 42 days prior to day 1 of protocol therapy
- Seronegative for active hepatitis B virus (HBV) (surface antigen negative and anti-hepatitis B virus core antibody [HBc] negative) for CD20+ patients only
- Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy
- Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)
- If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- Agreement by females and males of childbearing potential to use an effective (non-hormonal) method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the...
- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
- Leukemia-based therapy with chemotherapy with the exception of:
- Cytoreduction with steroid or hydroxyurea or a single dose of intrathecal chemotherapy is allowed before initiating the study
- Prior treatment with all-trans-retinoic acid (ATRA) for suspected acute promyelocytic leukemia (APL) is allowed
- Received previous treatment with any other asparaginase formulation
- Must not have received or planning to receive live vaccine while being on study or 2 weeks before and after completion of treatment. For CD20+ patients only: Must not have received any vaccines (live or non-live) 4...
- Known presence of Philadelphia chromosome positive (Ph+; t[9;22])
- Class III/IV cardiovascular disability according to the New York Heart Association classification. people with controlled, asymptomatic atrial fibrillation can enroll
- Parenchymal central nervous system (CNS) involvement
- Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment
- History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment
- History of intracranial thrombosis or history of recurrent thrombosis or grade 3 and greater pulmonary embolism (except for catheter-related thrombosis)
- Participants with history of grade ≥ 3 pancreatitis
- History of alcohol overuse if deemed relevant in investigator opinion
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent
- Uncontrolled active infection
- Clinically significant uncontrolled illness
- Other active malignancy
- Females only: Pregnant or breastfeeding
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Duarte, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Chicago, Illinois, United States
- New York, New York, United States
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 54 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Duarte, California, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Chicago, Illinois, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.