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Multicentric phase II trial to evaluate the efficacy and safety of Ibrutinib in combination with rituximab in patients with indolent clinical forms of Mantle Cell Lymphoma.
EU CTIS ID: 2024-512370-94-00
What this study is testing
To explore the efficacy of I+R combination as a therapeutic alternative to immuno-chemotherapy (R-CHOP regimen) in indolent forms of MCL by assessing the rate of complete responses achieved at 12 months of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
- Stable disease without evidence of clinical progression criteria for at least 3 months. Patients in prolonged therapeutic abstention may be included.
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
- Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
- Age 18 years or older.
You likely can't join if
- Aggressive histological variants: blastic and pleomorphic variants (blastoid).
- Known CNS infiltration.
- Subjects with expected therapy requirement for MCL in a short time (< 3 months).
- Patients with active hepatitis B or C infection or HIV infection. Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) will be excluded with the following exceptions. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing or antiviral prophylaxis. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Anticoagulation requirement with vitamin K antagonists.
- Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion
See the full eligibility criteria
Who can join
- Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
- Stable disease without evidence of clinical progression criteria for at least 3 months. Patients in prolonged therapeutic abstention may be included.
- Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. Men must agree to not donate sperm during and after the study. For females, these restrictions apply for 1 month after the last dose of study drug. For males, these restrictions apply for 3 months after the last dose of study drug.
- Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [ß-hCG]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
- Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study.
- Age 18 years or older.
- Subjects must not have received any prior therapies (excluding diagnostic splenectomy).
- Asymptomatic patients.
- Ann Arbor clinical stages I-IV.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (0-1).
- Subjects with a non-nodal MCL presentation with mainly bone marrow or peripheral blood involvement.
- Other asymptomatic clinical presentations are acceptable in case of low tumor burden, including nodal MCL with lymph node enlargement ≤ 3 cm in the maximum diameter and with low proliferation index (Ki-67 ≤ 30%).
- The following laboratory values at screening: ● ● Neutrophil count ≥ 1×10e9/L, Hemoglobin level ≥ 100 g/L or platelet count ≥ 100×10e9/L Transaminases (AST and ALT) ≤ 3 x ULN ●Total bilirubin ≤ 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin ●Creatinine ≤ 2 x ULN or calculated creatinine clearance ≥ 40 mL/min/1.73m2
What rules you out
- Aggressive histological variants: blastic and pleomorphic variants (blastoid).
- Known CNS infiltration.
- Subjects with expected therapy requirement for MCL in a short time (< 3 months).
- Patients with active hepatitis B or C infection or HIV infection. Positive test results for chronic HBV infection (defined as positive HBsAg serology) or positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) will be excluded with the following exceptions. Patients with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA is undetectable, provided that they are willing to undergo monthly DNA testing or antiviral prophylaxis. Patients who have protective titers of hepatitis B surface antibody (HBsAb) after vaccination or prior but cured hepatitis B are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA.
- Anticoagulation requirement with vitamin K antagonists.
- Past medical history of stroke or intracranial haemorrhage within 6 months prior to inclusion
- Required medication with strong CYP3A4/5 inhibitors.
- Any serious comorbidity that makes the patient unacceptable for receiving the treatment
- Concomitant or previous malignancies the last 2 years other than basal skin cancer or in situ uterine cervix cancer.
- Pregnancy or lactation.
- Major surgery within 4 weeks of inclusion.
- Proliferation index measured by Ki-67 > 30%.
- Clinically significant cardiovascular disease 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 (severe) cardiac disease as defined by the New York Heart Association Functional Classification.
- Vaccinated with live, attenuated vaccines within 4 weeks of randomization.
- Uncontrolled systemic infection requiring intravenous (IV) antibiotics.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the subject’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk.
- B-cell monoclonal lymphocytosis with MCL phenotype.
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
- Presence of B symptoms or any relevant symptoms related to the MCL.
- Nodal clinical forms with lymph node enlargement > 3 cm (maximum diameter).
- Cytopenias attributable to MCL: Neutrophil count < 1×10e9/L, Hemoglobin level < 100 g/L or platelet count < 100×10e9/L.
- Organ dysfunction related to MCL including creatinine level > 2 ULN or altered liver biochemistry (> 3x ULN).
- Gradual increase in different determinations of serum LDH attributable to MCL that exceeds 20% of the ULN.
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.