Is NCT07040982 recruiting in Duarte, CA?

Yes, NCT07040982 is currently recruiting participants at its Duarte, CA location. This b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 clinical trial is actively enrolling qualified participants.

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.

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Clinical Trial in Duarte, CA

Q: How do I join the b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 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.

About This B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Study in Duarte

This phase I trial tests the safety, side effects and best dose of asciminib as maintenance treatment for adults with Philadelphia chromosome positive acute lymphoblastic leukemia (ALL) who have undergone cellular therapies such as hematopoietic stem cell transplantation (HSCT) or chimeric antigen receptor (CAR) T cell therapy. Maintenance treatment is given to help keep cancer from coming back after it has disappeared following initial therapy. Asciminib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving asciminib may be safe and tolerable as maintenance treatment for adult patients with Philadelphia chromosome positive ALL who have undergone cellular therapies.

Sponsor: City of Hope Medical Center

Who Can Participate

Inclusion Criteria

PRE-SCREENING: Documented informed consent of the participant and/or legally authorized representative

PRE-SCREENING: Age ≥ 18 years

PRE-SCREENING: Participant was diagnosed with Ph+ ALL according to World Health Organization criteria. The BCR::ABL1 translocation may be detected by fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), next generation sequencing (NGS), or cytogenetics at least once any time prior to cellular therapy. Participants may have p190 or p220 isoform, and participants with T315I mutation are not excluded

PRE-SCREENING: Participant meets one of the following criteria:

Arm 1: Have a date for HSCT scheduled within the next 30 days or have received HSCT within the last 30 days. Note: all HSCT donors, conditioning regimens, and GVHD prophylaxis regimens will be acceptable.

Arm 2: Have a date for CAR T cell infusion scheduled within the next 30 days or have received CAR T cell infusion within the last 30 days

PRE-SCREENING: History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

PRE-SCREENING: History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Documented informed consent of the participant and/or legally authorized representative.

Assent, when appropriate, will be obtained per institutional guidelines

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Eastern Cooperative Oncology Group (ECOG) ≤ 2

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant is between day +30 and +150 after one of the following cellular therapies:

Arm 1: HSCT

Participants on Arm 1 must be fully engrafted post-HSCT.

Arm 2: CD19-targeted CAR T cell therapy (brexucabtagene autoleucel, tisagenlecleucel, obecabtagene autoleucel, investigational CD19 CAR T cell therapy)

Participants on Arm 2 must be fully recovered from cytopenia

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Day 30 (+/- 5 days) marrow post cellular therapy should show evidence of complete morphologic remission defined as \< 5% bone marrow (BM) blasts, no extramedullary disease, and transfusion independence

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Participant should have no morphological evidence of relapse

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Absolute neutrophil count (ANC) ≥ 500/mm\^3 for 3 days

NOTE: Patients are allowed growth factors

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Platelets ≥ 75,000/mm\^3

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Hemoglobin ≥ 9g/dL

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease)

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Aspartate aminotransferase (AST) ≤ 3.0 x ULN

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Alanine aminotransferase (ALT) ≤ 3.0 x ULN

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: serum creatinine \<1.5 mg/dL

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Left ventricular ejection fraction (LVEF) ≥ 50%

Note: To be performed within 28 days prior to day 1 of protocol therapy

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Bazett's corrected QT interval (QTcB) ≤ 480 ms

Note: To be performed within 28 days prior to day 1 of protocol therapy

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Oxygen (O2) saturation \> 90% on room air

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Seronegative for HIV antigen (Ag)/antibody (Ab) combination (combo), hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) OR

If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Meets other institutional and federal requirements for infectious disease titer requirements

Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

PATIENTS AFTER DAY +30 FOLLOWING CELLULAR THERAPY: Agreement by females and males of childbearing potential\

to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 120 days after the last dose of protocol therapy.

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

Prior treatment failure with asciminib

Treatment with strong inducers of CYP3A is not allowed and should be switched to an alternative at least 1 week prior to the start of study treatment

ARM 1: Treatment with prior HSCT is allowed

ARM 2: Treatment with prior CAR T cell therapy is allowed

Cardiac or cardiac repolarization abnormality, including any of the following:

History within 6 months prior to starting study treatment of myocardial infarction (MI), or coronary artery bypass graft (CABG)

Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block)

Fridericia's corrected QT interval (QTcF) at screening ≥ 450 msec (male patients), ≥ 470 msec (female patients)

Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome

History of pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis

ARM 1: Active grade 3 or higher graft-versus-host disease (GVHD) after allogeneic HSCT within 14 days of enrollment. Note: prednisone administration (flat dose of 0.5 mg/kg) is allowed. Patients receiving any other medication to control active/progressive GVHD will be excluded

Clinically significant uncontrolled illness

Active infection not responding to treatment

Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

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 (NCT07040982) 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.

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Treatment Options in Duarte, CA

If you're searching for b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 treatment options in Duarte, CA, this clinical trial (NCT07040982) 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 clinical trial. You'll receive care from experienced b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 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 b acute lymphoblastic leukemia with t(9;22)(q34.1;q11.2); bcr-abl1 clinical trials near you to find additional studies recruiting in your area.

B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 Clinical Trial in Duarte, CA

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