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New treatment option for Large B-cell Lymphoma
Official title Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT07316010
What this study is testing
What is Lymphodepleting Chemotherapy?
Lymphodepleting Chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for large b-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of the main clinical research study is to learn if treatment with a chimeric antigen receptor (CAR) T-cell therapy called lisocabtagene maraleucel (liso-cel) can help to prevent recurrence of large B-cell cell lymphoma in patients who have achieved complete response (CR) after standard first-line therapy but have tested positive for lymphoma DNA. CAR T therapy is a type of treatment that uses your own immune cells to fight your cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients must meet the following criteria for study entry: 2\. Age ≥18 years 3. Histologically diagnosed 4. Diffuse large B-cell lymphoma, not...
- R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)
- DA-EPOCH-R
- Polatuzumab-R-CHP 8. Achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment
- Or PR only if suitable for observation, defined as either negative biopsy or deemed too small or not amenable to biopsy 9. Had a response assessment...
You likely can't join if
- people will be ineligible for this study if they meet any of following criteria:
- Having radiologically confirmed relapsed/refractory disease.
- Have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities \> Grade 1) with the exception of...
- Known central nervous system lymphoma or leptomeningeal disease.
- Suspicious case at end of treatment from first line treatment should be evaluated with brain MRI with or without lumber puncture.
- Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 2 years and felt to be at low risk for...
See the full eligibility criteria
Who can join
- Patients must meet the following criteria for study entry: 2\. Age ≥18 years 3. Histologically diagnosed 4. Diffuse large B-cell lymphoma, not otherwise specified (NOS) or 5. High grade B-cell lymphoma (NOS or MYC and...
- R-CHOP (cyclophosphamide, doxorubicin, vincristine sulfate, and prednisone)
- DA-EPOCH-R
- Polatuzumab-R-CHP 8. Achieved complete metabolic response by Lugano criteria4 at the end of treatment response evaluation after first line treatment
- Or PR only if suitable for observation, defined as either negative biopsy or deemed too small or not amenable to biopsy 9. Had a response assessment within 8 weeks following completion of first line standard of care...
- Absolute neutrophil count (ANC) ≥1.0 × 109 /L\ \ Growth factor permitted during screening
- Platelet count ≥75 × 109 /L
- Hemoglobin ≥ 8 g/dL
- Total bilirubin ≤ 3 ULN, unless consistent with Gilbert's syndrome
- AST and ALT ≤ 3x upper limit of normal (ULN)
- Alkaline phosphatase \< 2.5 ULN
- Creatinine clearance \>40 ml/min calculated by modified Cockcroft-Gault formula or estimated GFR (eGFR) \> 40 ml/min/1.73m2
- Cardiac ejection fraction ≥ 40%, no evidence of clinically significant pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings 13. All people must
- Agree to refrain from donating blood while on study treatment, and for at least 12 months following the last dose of study treatment. 14\. The effects of liso-cel on the developing human fetus are unknown. For this...
- Postmenopausal (non-chemically induced menopause in greater than or equal to 12 consecutive months).
- History of hysterectomy or bilateral salpingo-oophorectomy.
- Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
- History of bilateral tubal ligation or another surgical sterilization procedure. 15\. Females of childbearing potential (FCBP) must:
- Have 2 negative pregnancy tests as verified by the Investigator (one negative serum beta-human chorionic gonadotropin [ß-hCG] pregnancy test result at screening, and within 7 days prior to the first dose of LD...
- Either commit to true abstinence from heterosexual contact (which must be reviewed monthly and source documented) or agree to use, and be able to comply with, effective contraception without interruption. Contraception...
- Agree to abstain from breastfeeding during study participation and for at least 12 months following LD chemotherapy.
- Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy...
- Male Practice true abstinence (which must be reviewed monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for 12 months after LD chemotherapy even...
What rules you out
- people will be ineligible for this study if they meet any of following criteria:
- Having radiologically confirmed relapsed/refractory disease.
- Have not recovered from non-hematological AEs due to prior first line therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia.
- Known central nervous system lymphoma or leptomeningeal disease.
- Suspicious case at end of treatment from first line treatment should be evaluated with brain MRI with or without lumber puncture.
- Any prior history of other malignancy besides B-NHL, unless the patient has been free of disease for ≥ 2 years and felt to be at low risk for recurrence by the treating physician, except:
- Adequately treated localized non-melanoma skin cancer without evidence of disease.
- Adequately treated localized prostate cancer without evidence of disease.
- Adequately treated localized breast cancer without evidence of disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study outcomes at undue risk.
- Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection...
- Patients with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. The treatment and monitoring of hepatitis B will follow the institutional standard of practice...
- History of severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody.
- History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of...
- Clinically significant cardiovascular diseases such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4...
- History or presence of clinically significant central nervous system (CNS) pathology such as epilepsy (a seizure disorder), a seizure within the past 2 years prior to signing the ICF, paresis, aphasia, stroke, cerebral...
- Lactating or pregnant people. Pregnant women are excluded from this study for unknown potential for teratogenic or abortifacient effects by liso-cel. Because there is an unknown but potential risk for adverse events in...
- Had blood transfusion within 14 days prior to first dose of LDC.
- Administration of any investigational agent within 28 days of first dose of study drug.
- Patients who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.
- Administration of a live, attenuated vaccine within 4 weeks before lymphodepleting treatment administration or anticipation that such a live, attenuated vaccine will be required during the study.
- Patients taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to \ 20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note...
- Patients who have concern for the accurate assessment of neuro toxicity.
- Patients who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.