Evaluation of Parsaclisib plus Bendamustine and Rituximab in patients with Newly Diagnosed Mantle Cell Lymphoma

Purpose

The purpose of this trial is to study whether the condition of patients with newly diagnosed mantle cell lymphoma improves on parsaclisib plus bendamustine and rituximab.

Costs

Participation in the clinical trial is free of charge.

Condition

Lymphoma

Trial phase

Phase 3 trial (what are the 4 phases of clinical trials?)

Countries

Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Israel, Italy, Poland, Portugal, Romania, Spain, Switzerland, Turkey, Ukraine

Which Lymphoma patients can access this clinical trial?

Patients who wish to participate in this clinical trial need to fulfill a number of eligibility criteria. Some are very specific and we will require the medical records from your doctor.

You could be eligible if:

  • You can take part in the trial in Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Israel, Italy, Poland, Portugal, Romania, Spain, Switzerland, Turkey, Ukraine;
  • You have not received any previous systemic antilymphoma therapies;
  • You have pathologically confirmed Mantle Cell Lymphoma by a local laboratory;
  • You have histologically confirmed CD20 expression of Mantle Cell Lymphoma;
  • You are ineligible for high-dose chemotherapy and ASCT;
  • You have a radiographically measurable lymphadenopathy, defined as at least 1 nodal lesion > 1.5 cm in LDi or at least 1 extranodal lesion > 1.0 cm in LDi per Lugano criteria;
  • You have an ECOG (Eastern Cooperative Oncology Group) Performance Status of 0 to 2.

If you meet all of these conditions you might be allowed to enter the screening process.

You are not eligible if:

  • You are not being treated in Austria, Belgium, Canada, Czech Republic, Denmark, Finland, Israel, Italy, Poland, Portugal, Romania, Spain, Switzerland, Turkey, Ukraine;
  • You show presence of central nervous system (CNS) lymphoma (either primary or secondary) or leptomeningeal disease;
  • You have a significant uncontrolled medical condition such as renal, hepatic, hematological, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease;
  • You have a history of stroke or intracranial hemorrhage within 6 months of this trial;
  • You have an HIV infection;
  • You have a hepatitis B (HBV) or hepatitis C (HCV) infection: Participants positive for HBV surface antigen or HBV core antibody will be eligible if they are negative for HBV DNA; you could be considered for prophylactic antiviral therapy. If you are positive for HCV antibody, you could be eligible if you are negative for HCV RNA;
  • You have a cardiac disease such as unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months before the start of this trial;
  • You have congestive heart failure or uncontrolled arrhythmia;
  • You are unable to swallow and retain oral medication, you have malabsorption syndrome, a disease significantly affecting GI function, a total resection of the stomach or small bowel, ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

If you meet all of these conditions you might be allowed to enter the screening process.

Learn how to access this clinical trial

If you meet the conditions and you would like to participate in this study, please register your interest by filling in the Participation Form and we will contact you shortly with additional information on the screening process.

Be fully informed before you show interest in taking part in this study

Joining a clinical trial study can be unnerving for both you and your loved ones, which is why you first need to consult your treating doctor to weigh up the pros and cons. We will try to give you all the information you and your doctor need, so you and your doctor can make the best decision for you.

Please be aware that as part of the screening process you and your doctor will need to send us your medical records.

Be aware:

  • Being selected for the study depends on whether you are eligible for the trial;
  • At all times your data will be kept safe and protected;
  • If you join the trial, you could be randomly assigned to a placebo group.

Yes, I want to participate

Fill in the form below so we can contact you with more details about this study.

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Thank you for registering your interest in this clinical trial!

We will get in touch with you shortly at . If you have any questions, send an email to [email protected]

463 Evaluation of Parsaclisib plus Bendamustine and Rituximab in patients with Newly Diagnosed Mantle Cell Lymphoma