Evaluation of Parsaclisib plus Rituximab or Obinutuzumab in patients with Lymphoma that has stopped responding to treatment

Purpose

The purpose of this trial is to study whether the condition of patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma improves on parsaclisib with either rituximab or obinutuzumab.

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, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Spain, Turkey, Ukraine, United Kingdom

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, Canada, Czech Republic, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Poland, Spain, Turkey, Ukraine, United Kingdom;
  • You have a diagnosis of Grade 1, 2, or 3a Follicular Lymphoma (FL) or Marginal Zone Lymphoma, including extranodal, nodal, and splenic subtypes;
  • You have been treated with at least 1 anti-CD20 mAb (either alone or together with chemoimmunotherapy) and at least 2 doses of an anti-CD20 therapy;
  • Your disease has come back (relapsed) or became worse (progressed), or did not respond anymore to the most recent previous treatment which is not an anti-CD20 therapy (refractory);
  • You are a candidate for treatment with either rituximab or obinutuzumab, because:
    • Your disease came back, worsened or stopped responding to treatment after at least 2 lines of antilymphoma treatment, or because
    • Your disease came back after it did not get worse for at least 12 months after 1 line of anti-CD20 therapy (given either alone or together with chemoimmunotherapy);
  • You have at least one nodal tumor with a diameter of > 1.5 cm or at least one extranodal tumor with a diameter > 1.0 cm;
  • You have a ECOG performance status score (scale to assess a patient’s daily living abilities) of fully active-0, slightly restricted-1, or slightly restricted-2.

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

You are not eligible if:

  • You have a known history of Non-Hodgkin’s Lymphoma;
  • You have Grade 3b FL;
  • You have a central nervous system (CNS) lymphoma or you have leptomeningeal disease
  • Your tumor does not respond to anti-CD20 therapy;
  • You have been under treatment with PI3K inhibitors;
  • You have had an allogeneic stem cell transplant within the past 6 months, or autologous stem cell transplant within 3 months of starting this study;
  • You have an active medical condition, including, but not limited to, kidney, liver, blood, gut, hormonal, lung, neurological, brain, or psychiatric disease;
  • You have a history of stroke or brain bleedings within 6 months of starting this study;
  • You have an HIV infection;
  • You have an active Hepatitis B or C infection that requires treatment or are at risk for HBV reactivation;
  • You have a severe or unstable heart disease;
  • You have a NYHA (New York Heart Association scoring system for heart failure) score of severe-3 or very severe-4;
  • You are unable to swallow oral medicines, or your body is not able to take up the medicine.

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 [email protected]. If you have any questions, send an email to [email protected]

461 Evaluation of Parsaclisib plus Rituximab or Obinutuzumab in patients with Lymphoma that has stopped responding to treatment
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