Evaluation of Tafasitamab plus Parsaclisib in patients with Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

Purpose

The purpose of this trial is to study whether the condition of patients with relapsed or refractory non Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CCL) improves on Tafasitamab plus Parsaclisib.

Costs

Participation in the clinical trial is free of charge.

Condition

Leukemia or Lymphoma

Trial phase

Phase 1b/2a Trial (what are the 4 phases of clinical trials?)

Countries

France, Germany, Italy, Spain

Which Leukemia or 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 France, Germany, Italy, Spain;
  • You have an R/R B-cell malignancy of the following types: Cohort 1: Diffuse large B-cell lymphoma (DLBCL), T-cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr virus–positive DLBCL of the elderly, Grade 3b Follicular Lymphoma, highgrade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma), histological transformation from an earlier diagnosis of low-grade lymphoma (such as FL, MZL, CLL) into DLBCL. Cohort 2: Mantle Cell Lymphoma (MCL) with documentation of either overexpression of cyclin D1 or t(11;14). Cohort 3: FL Grade 1, 2, and 3a. Cohort 4: Marginal Zone Lymphoma (MZL), including extranodal, nodal, and splenic subtypes. Cohort 5: Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL);
  • You have previously received at least 2 systemic treatment regimens as follows: Cohorts 1 and 2 (DLBCL, MCL): Must have been previously treated with at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 antibody (you have been administered at least 6 doses). This includes treatments such as chemotherapy plus rituximab or obinutuzumab. Cohorts 3 and 4 (FL, MZL): Must have been previously treated with at least 1 prior chemoimmunotherapy or immunotherapy regimen that included an antiCD20 antibody (you have been administered at least 6 doses). This includes treatments such as rituximab or obinutuzumab monotherapy or chemotherapy plus rituximab or obinutuzumab, with or without rituximab or obinutuzumab maintenance. Cohort 5 (CLL/SLL): Must have been previously treated with at least 1 prior systemic therapy including a BTK inhibitor regimen or chemoimmunotherapy regimen that included an anti-CD20 antibody;
  • You have relapsed, progressive, or refractory Non Hodgkin's Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL) : Relapsed: progressive disease (PD) after response of complete response (CR) to prior therapy. Progressive: progressive disease (PD) after response of partial response (PR) or stable disease to prior therapy. Refractory: achieved less than partial response (PR) to the last prior therapy, or achieved a complete response (CR) or partial response PR that lasted < 6 months before progressive disease (PD).
  • You have a lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest transverse diameter and ≥ 1.0 cm in the longest perpendicular diameter as assessed by CT or MRI);
  • You have an Eastern Cooperative Oncology Group (ECOG) Scale of 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 receiving treatment in one of the countries specified for this study;
  • You have a history of or evidence of CNS lymphoma (primary and secondary);
  • You have had an allogeneic stem cell transplantation within the past 6 months, or autologous stem cell transplant (ASCT) within 3 months before starting this trial;
  • You have previously been under treatment with CD19-targeted therapy or PI3K inhibitors;
  • You have or had a clinically significant cardiac disease, including unstable angina, acute myocardial infarction, congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of starting this trial;
  • You have an uncontrolled medical condition such as renal, hepatic, hematologic, GI, endocrine, pulmonary, neurological, cerebral, or psychiatric disease;
  • You have a history of stroke or intracranial hemorrhage within 6 months of starting this trial;
  • You have had a positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA (used for testing for hepatitis C). Participants with positive serology must be tested locally for HCV RNA and are eligible in case of negative HCV RNA test results;
  • You have had a positive test result for chronic HBV infection (hepatitis B). You can join the trial, however, if HBV DNA is undetectable when tested at the clinical trial site, provided that you are willing to undergo ongoing DNA testing. Antiviral prophylaxis may be administered as per institutional guidelines. If you have protective titers of HBsAb after vaccination or prior but cured hepatitis B, you may still be eligible;
  • You have an HIV infection;
  • You have an inability to swallow and retain oral medication, you have a 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;
  • You have a history or evidence of interstitial lung disease.

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]

460 Evaluation of Tafasitamab plus Parsaclisib in patients with Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia