Is NCT05464719 recruiting in Houston, TX?

Yes, NCT05464719 is currently recruiting participants at its Houston, TX location. This large b-cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the large b-cell lymphoma clinical trial in Houston?

To join this clinical trial in Houston, 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 Houston 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.

Large B-cell Lymphoma Clinical Trial in Houston, TX

About This Large B-cell Lymphoma Study in Houston

To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.

Sponsor: M.D. Anderson Cancer Center

Who Can Participate

Inclusion Criteria

Eligible subjects will be considered for inclusion in this study if they meet the following criteria:

Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma

Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial

≥ 18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy

At least 30 days must have elapsed since CAR T-cell therapy infusion

No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment

No additional anti-tumoral therapy, with the

Exclusion Criteria

of palliative radiotherapy, must have been received after CAR T-cell therapy

Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days prior to screening assessment.

Platelet count of ≥ 50×109/L without transfusion for 3 days prior to screening assessment.

Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

Serum alanine transaminase (ALT) or aspartate transaminase (AST) ≤ 2.5 upper limit of normal (ULN)

Total bilirubin ≤2 mg/dL, except in subjects with Gilbert's syndrome.

Cardiac ejection fraction ≥ 45% with no evidence of clinically significant pericardial effusion

Baseline oxygen saturation \> 92% on room air

No evidence or suspicion of lymphoma actively involving the central nervous system (CNS)

Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)

Resolution of any previous CRS and/or ICANS to grade 0. 4.3 Exclusion criteria Subjects will be ineligible for this study if they meet the following criteria:

Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)

History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. prostate, cervix, bladder, breast) unless disease free for at least 12 months

History of Richter's transformation of chronic lymphocytic leukemia (CLL)

Treatment with CAR T-cell therapy on clinical trial as immediate treatment before enrollment

Prior treatment with lonca

Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Principal investigator

Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of HIV, hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.

Subjects with active cardiac atrial or cardiac ventricular lymphoma involvement

History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrolment

Primary immunodeficiency

History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring active systemic immunosuppression/systemic disease modifying agents within the last 2 years

History of clinically significant deep vein thrombosis or pulmonary embolism within 1 month of enrollment per investigators discretion.

Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

History of severe immediate hypersensitivity reaction to any of the agents used in this study

Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the PBD on the fetus or infant.

Subjects of both genders who are not willing to practice birth control. Women of childbearing potential must use a highly effective method of contraception (hormonal birth control such as birth control pills, intravaginal ring, skin patch, implant or injection, intrauterine device or surgical sterilization) until 9 months after last dose of lonca, and men with female partners who are of childbearing potential should use a condom when sexually active until 6 months after the last dose of lonca

In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation Trial Treatments

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 Houston?

Yes, this clinical trial (NCT05464719) has an active research site in Houston, TX 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.

Large B-cell Lymphoma Treatment Options in Houston, TX

If you're searching for large b-cell lymphoma treatment options in Houston, TX, this clinical trial (NCT05464719) 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 Houston research site is actively enrolling participants for this clinical trial. You'll receive care from experienced large b-cell 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 large b-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Large B-cell Lymphoma Clinical Trial in Houston, TX

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