Is NCT07400029 recruiting in Basking Ridge, NJ?

Yes, NCT07400029 is currently recruiting participants at its Basking Ridge, NJ location. This acute lymphoblastic leukemia clinical trial is actively enrolling qualified participants.

Is participation in this Basking Ridge 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 Basking Ridge, NJ

Q: How do I join the acute lymphoblastic leukemia clinical trial in Basking Ridge?

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

About This Acute Lymphoblastic Leukemia Study in Basking Ridge

The researchers are doing this study to find out whether obecabtagene autoleucel (obe-cel) is an effective treatment for people with B-cell acute lymphoblastic leukemia (ALL) that is in complete remission (CR, meaning all signs of cancer are gone) with no measurable residual disease (MRD-negative, meaning there are no detectable cancer cells). Participants in this study will have received past treatment for their B-cell ALL, and their disease will be in MRD-negative CR for the first time (first MRD-negative CR).

Sponsor: Memorial Sloan Kettering Cancer Center

Who Can Participate

Inclusion Criteria

Diagnosis of CD19+ B-cell ALL.

Both Ph-negative and Ph-positive are allowed

Patients with EMD must have detectable disease in the bone marrow (by flow cytometry or molecular methods) in order to follow MRD.

Patients aged ≥ 40 years at time of screening A.

Patients aged 30-39 years (at time of Screening A) are allowed in the presence of high-risk comorbidities or poor tolerability of chemotherapy (e.g. history or experienced pancreatitis with therapy, BMI ≥40kg/m2, underlying liver disease precluding safer administration of pediatric inspired regimens, any further combination of documented severe comorbidities that the investigator judges to be incompatible with administering an intensive pediatric or pediatric-inspired standard chemotherapy regimen).

In MRD negative CR or CR with incomplete hematologic recovery (CRi) at the time of screening. MRD will be assessed by flow cytometry and/or molecular testing such as ClonoSEQ at the minimum sensitivity of 10-4 from the bone marrow. Patients with MRD \<10\^-4 will be eligible.

Patients may receive more than one course of upfront induction and/or consolidation, but must be in MRD- CR/CRi at time of screening, within 4 months from initiation of treatment. The 4-month window will be measured from the first day of anti-leukemic therapy initiation (excluding steroid prophase) until the Screening A test for the trial. Frontline regimens include but are not limited to:

HyperCVAD or mini-hyper-CVD

Asparaginase-containing multiagent chemotherapy (e.g. CALGB10403, pediatric inspired chemo)

Inotuzumab or blinatumomab with or without chemotherapy

Tyrosine kinase inhibitor plus steroids, chemotherapy, or blinatumomab \- Adequate organ function at time of screening A, including:

ALT or AST ≤5x ULN and total bilirubin ≤2 (or ≤3 if history of Gilbert's syndrome or leukemic infiltration of the liver)

Serum creatinine \<2.0mg/dL

SaO2 ≥92% on room air

Left ventricular ejection fraction (LVEF) ≥50% within 1 month of screening

ECOG performance status 0-2

CD19 expression is required at any time since diagnosis. CD19 expression may be detected by immunohistochemistry or by flow cytometry. Patients receiving prior blinatumomab are eligible if there is no documentation of CD19-negative disease after blinatumomab.

CNS1 status must be documented at time of screening by CSF assessment. Patients with prior CNS2 or CNS3 disease must be CNS1 at screening and have no residual CNS deficits or symptoms.

Patients will need to adhere to institutional contraception guidelines for a minimum of 1 year.

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

Exclusion Criteria

Burkitt's leukemia or lymphoma

Patients with measurable extramedullary disease at screening are excluded. Patients with prior history of extramedullary disease are allowed after documentation of disease resolution by either PET/CT scan (or CT with contrast if PET cannot be performed).

The following medications are excluded:

Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.

Systemic chemotherapy: Must be discontinued 7 days prior to leukapheresis or 7 days prior to starting lymphodepleting chemotherapy if used during bridging.

Tyrosine kinase inhibitors: Must be discontinued 48 hours prior to apheresis and 48 hours prior to starting lymphodepleting chemotherapy, if used during bridging.

Blinatumomab must be discontinued 5 days before apheresis

Inotuzumab must be discontinued 2 weeks before apheresis to allow T cell recovery

Patients with uncontrolled systemic fungal, bacterial, viral or other infection at time of leukapheresis or at time of CAR T cell infusion

Blinatumomab may not be used as bridging therapy following apheresis

Positive test indicating the presence of active infection with the following pathogens: HIV, Hepatitis B (detectable Hep B DNA by PCR or Hep B surface antigen), Hepatitis C (detectable Hep C RNA by PCR), HTLV, Syphilis. The tests required will be agreed upon with the manufacturer to comply with manufacturer's regulatory and manufacturing requirements.

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 Basking Ridge?

Yes, this clinical trial (NCT07400029) has an active research site in Basking Ridge, NJ 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 Basking Ridge, NJ

If you're searching for acute lymphoblastic leukemia treatment options in Basking Ridge, NJ, this clinical trial (NCT07400029) 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 Basking Ridge research site is actively enrolling participants for this 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 Basking Ridge, NJ

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