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Rituximab, bendamustine and cytarabine followed by venetoclax (V-RBAC) in high-risk elderly patients with mantle cell lymphoma (MCL)
EU CTIS ID: 2024-511533-35-00
What this study is testing
To evaluate whether the addition of venetoclax after R-BAC to HR patients with MCL, as defined above, improves the results of the standard R-BAC, in terms of PFS.
- 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
- Previously untreated patients with MCL aged ≥65 years if they are FIT according to the geriatric CGA assessment.
- age ≤64 years not eliglible to high-dose chemotherapy plus transplantation at physician's judgement (details for non eligibility to be recorded by means of the CIRS, Cumulative Illness rating Scale).
- Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions.
- ECOG performance status ≤2.
- Positivity for cyclin D1 and/or SOX11 [the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative].
- Adequate renal function (Creatinine clearance >50 mL/min), with preserved diuresis
You likely can't join if
- Human immunodeficiency virus (HIV) positive.
- Uncontrolled diabetes mellitus
- Active secondary malignancy
- Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol.
- Major surgery within 4 weeks of study Day 1.
- HBsAg+
See the full eligibility criteria
- Previously untreated patients with MCL aged ≥65 years if they are FIT according to the geriatric CGA assessment.
- age ≤64 years not eliglible to high-dose chemotherapy plus transplantation at physician's judgement (details for non eligibility to be recorded by means of the CIRS, Cumulative Illness rating Scale).
- Measurable nodal or extranodal disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions.
- ECOG performance status ≤2.
- Positivity for cyclin D1 and/or SOX11 [the latter being mandatory in cases lacking cyclin D1- or t(11;14)-negative].
- Adequate renal function (Creatinine clearance >50 mL/min), with preserved diuresis
- Adequate liver function: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) <2.5 x upper limit of normal (ULN) value, total bilirubin <1.5 x ULN, unless directly attributable to the patient’s tumor or to congenital causes.
- Hepatitis B core antibody (HBcAb) positive/HBsAg negative/HBV-DNA negative patients may be enrolled if correct antiviral prophylaxis is administered at least 2 weeks before initiating protocol treatment.
- Written informed consent
- Human immunodeficiency virus (HIV) positive.
- Uncontrolled diabetes mellitus
- Active secondary malignancy
- Known hypersensitivity or anaphylactic reactions to murine antibodies and proteins, to Bendamustine or mannitol.
- Major surgery within 4 weeks of study Day 1.
- HBsAg+
- HCVAb+ patients with active viral replication (HCV-RNA+ with AST>2 x normal limit)
- Any co-existing medical or psychological condition that would preclude participation in the study or compromise the patient’s ability to give informed consent, or that may affect the interpretation of the results, or render the patient at high risk from treatment complications.
- CNS involvement
- Chronic treatment with strong or moderate CYP3A inhibitors (e.g. ketoconazole, ritonavir, clarithromycin, itraconazole, voriconazole)
- Previous treatment for lymphoma
- Disease confined to the bone marrow/peripheral blood/spleen, without any other nodal or extranodal involvement
- In-situ MCL.
- Medical conditions or organ injuries that could interfere with administration of therapy.
- Active bacterial, viral, or fungal infection requiring systemic therapy
- Seizure disorders requiring anticonvulsant therapy
- Severe chronic obstructive pulmonary disease with hypoxiemia.
- History of severe cardiac disease: New York Heart Association (NYHA) functional class III-IV, myocardial infarction within 6 months, ventricular tachyarrhythmias, dilatative cardiomyopathy, or unstable angina.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.