Is NCT06934382 recruiting in Philadelphia, PA?

Yes, NCT06934382 is currently recruiting participants at its Philadelphia, PA location. This t-cell acute lymphoblastic leukemia/lymphoma clinical trial is actively enrolling qualified participants.

Is participation in this Philadelphia 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.

T-Cell Acute Lymphoblastic Leukemia/Lymphoma Clinical Trial in Philadelphia, PA

Q: How do I join the t-cell acute lymphoblastic leukemia/lymphoma clinical trial in Philadelphia?

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

Who Can Participate

Inclusion Criteria

Patients must meet all the following criteria to be eligible for enrollment into the study:

Patients (ages ≥ 18 years) or parent/legal guardians (for patients ages \< 18 years) must provide signed, written informed consent according to local IRB and institutional requirements.

Ages 0 to 29 years.

T-ALL/T-LLy in second or greater relapse, first relapse post-transplant, or chemotherapy-refractory disease. Specifically:

Second or greater relapse or post-transplant relapse, defined as:

BM with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease after second documented CR; OR

Flow cytometric confirmation of relapsed T-ALL of at least 0.1% after second CR documented to have been MRD negative \< 0.1%; OR

Any detectable relapsed disease post-allogeneic HSCT with flow cytometric confirmation of T-ALL of at least 0.1%; OR

Biopsy confirmed evidence of relapsed T-LLy after second CR; OR

Any detectable disease post-allogeneic transplant with biopsy confirmed evidence of T-LLy

Refractory disease, defined as:

Primary refractory T-ALL or T-LLy, defined as failure to achieve CR after induction chemotherapy, per investigator assessment and based on biopsy-or MRD-confirmed evidence of residual T-ALL or T-LLy; OR

Relapsed, refractory disease, defined as \> 0.1 % MRD or morphologic evidence of disease or evidence of residual T-LLy after 1 course of re-induction chemotherapy for patients who have relapsed after previously achieving a CR NOTE: Patients with mixed phenotype acute leukemia with T cell dominant phenotype may be enrolled if the aforementioned criteria are met.

Documentation of CD7 expression on leukemic or T-LLy blasts (defined as at least 90% of blasts positive for CD7 by flow cytometry or immunohistochemistry).

Patients with prior or current history of CNS3 disease will be eligible if CNS disease is responsive to therapy

Eligible for myeloablative conditioning for and allogeneic HSCT based on the investigator's assessment with an available donor identified by a FACT accredited transplant center.

Lansky Performance Status (ages \< 16 years at time of consent) or Karnofsky Performance Status (KPS) (ages ≥ 16 years at time of consent) score of ≥ 50.

Patients of childbearing potential must have a negative urine or serum pregnancy test at screening.

Adequate organ function defined as:

Adequate Serum creatinine based on age/gender

ALT ≤ 5x ULN in the absence of ALL infiltration of the liver

Bilirubin ≤ 3 × ULN for age Note: ALT and/or bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to ALL infiltration of the liver.

Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \<Grade 3 hypoxia; DLCO ≥40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the investigator.

Cardiac echocardiography (ECHO) with left ventricular shortening fraction (LVSF) ≥ 30% or left ventricular ejection fraction (LVEF) ≥ 50%. In cases where quantitative assessment of LVSF/LVEF is not possible, a statement by the cardiologist that the ECHO shows qualitatively normal ventricular function will suffice

Patients who are sexually active and of reproductive potential must agree to use an acceptable form of highly effective contraception from consent to 12 months after BEAM 201 infusion. 4.2 Exclusion Criteria Patients who meet any of the following criteria will be disqualified from entering the study:

Active hepatitis B or active hepatitis C

Active HTLV infection

HIV infection

Uncontrolled, active bacterial, viral, or fungal infection.

CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.

Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.

Receipt of prior CD7 targeted therapy.

Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.

Acute GVHD that is grade ≥ 2 and requiring systemic immunosuppression (corticosteroids), or chronic GVHD that is mild, moderate, or severe and requiring systemic immunosuppression (corticosteroids). Grade 1 acute GVHD not requiring immunosuppression is allowable.

Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).

Any other condition that would make the patient ineligible for HSCT as determined by the investigator.

Known primary immunodeficiency or BM failure syndrome.

Atrial fibrillation/flutter (not including isolated episodes that responded to medical management)

Clinically significant pericardial effusion

Myocardial infarction within the last 12 months

QT interval corrected for heart rate \> 480 msec

Cardiac dysfunction NYHA (New York Heart Association) III or IV

Patients with an autoimmune disorder requiring systemic immunosuppressive therapy that cannot be safely withheld for 3 months. Concurrent use of systemic corticosteroids for diagnoses unrelated to T-ALL/T-LLy is prohibited, with exception of physiologic corticosteroid replacement therapy treatment for adrenal insufficiency.

Pregnant or breastfeeding

Exclusion Criteria

Patients who meet any of the following criteria will be disqualified from entering the study:

Active hepatitis B or active hepatitis C

Active HTLV infection

HIV infection

Uncontrolled, active bacterial, viral, or fungal infection.

CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.

Clinically active CNS dysfunction or known history of irreversible central neurological toxicity related to prior antileukemic therapy.

Receipt of prior CD7 targeted therapy.

Radiation therapy within 2 weeks prior to completion of screening, other than prophylaxis for CNS disease.

Undergone HSCT within 90 days prior to completion of screening (or donor leukocyte infusion, if received within 30 days prior to completion of screening).

Any other condition that would make the patient ineligible for HSCT as determined by the investigator.

Known primary immunodeficiency or BM failure syndrome.

Atrial fibrillation/flutter (not including isolated episodes that responded to medical management)

Clinically significant pericardial effusion

Myocardial infarction within the last 12 months

QT interval corrected for heart rate \> 480 msec

Cardiac dysfunction NYHA (New York Heart Association) III or IV

Pregnant or breastfeeding

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 Philadelphia?

Yes, this clinical trial (NCT06934382) has an active research site in Philadelphia, PA 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.

T-Cell Acute Lymphoblastic Leukemia/Lymphoma Treatment Options in Philadelphia, PA

If you're searching for t-cell acute lymphoblastic leukemia/lymphoma treatment options in Philadelphia, PA, this clinical trial (NCT06934382) 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 Philadelphia research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced t-cell acute lymphoblastic leukemia/lymphoma 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 t-cell acute lymphoblastic leukemia/lymphoma clinical trials near you to find additional studies recruiting in your area.

T-Cell Acute Lymphoblastic Leukemia/Lymphoma Clinical Trial in Philadelphia, PA

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