Is NCT06918431 recruiting in Duarte, CA?

Yes, NCT06918431 is currently recruiting participants at its Duarte, CA location. This acute lymphoblastic leukemia clinical trial is actively enrolling qualified participants.

How do I join the acute lymphoblastic leukemia clinical trial in Duarte?

To join this clinical trial in Duarte, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Duarte clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Acute Lymphoblastic Leukemia Clinical Trial in Duarte, CA

About This Acute Lymphoblastic Leukemia Study in Duarte

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 peopl

Sponsor: City of Hope Medical Center

Who Can Participate

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 ≤ 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 last dose of protocol therapy. For participants taking rituximab, effective birth control or abstinence to be used for at least 12 months after last dose

Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)

Exclusion Criteria

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 weeks before rituximab

Known presence of Philadelphia chromosome positive (Ph+; t\[9;22\])

Class III/IV cardiovascular disability according to the New York Heart Association classification. Subjects 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)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Duarte?

Yes, this clinical trial (NCT06918431) has an active research site in Duarte, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Lymphoblastic Leukemia Treatment Options in Duarte, CA

If you're searching for acute lymphoblastic leukemia treatment options in Duarte, CA, this clinical trial (NCT06918431) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Duarte research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced acute lymphoblastic leukemia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute lymphoblastic leukemia clinical trials near you to find additional studies recruiting in your area.

Acute Lymphoblastic Leukemia Clinical Trial in Duarte, CA

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