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No longer recruiting (closed or complete)Last updated: 1 February 2024

ELARA: This phase II trial is testing a new biological therapy (tisagenlecleucel) that is made using a patient's T-Cells, to treat people who have been diagnosed with Follicular Lymphoma but have got worse or not responded to other therapiesA Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

ELARA

Clinical summary

Summary

This trial is treating patients with refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A). Tisagenlecleucel(CTL019) will be administered as a single infusion.

Conditions

This trial is treating people with follicular lymphoma

Eligibility

Inclusion

  • Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
  • Radiographically measurable disease at screening

Exclusion

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Prior anti-CD19 therapy
  • Prior gene therapy
  • Prior adoptive T cell therapy
  • Prior allogeneic hematopoietic stem cell transplant
  • Active CNS involvement by malignancy

Other protocol-defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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No longer recruiting (closed or complete) hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

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