Factors for predicting treatment success and severe adverse events of chimeric antigen receptor (CAR) T-cell therapy in relapsed or refractory diffuse large B-cell lymphoma

This is a protocol for a Cochrane Review (prognosis). The objectives are as follows:

To identify and meta-analyse prognostic factors for efficacy and safety of CAR T-cell therapy for treating aggressive large B-cell lymphomas before therapy has started.


  • Adult patients with a confirmed diagnosis of a relapsed or refractory aggressive large B-cell lymphoma (DLBCL, PMBCL, FL grade 3b, HGBCL) who received CAR T-cell therapy

Index factor(s)

  • Any prognostic factor


  • Not applicable, no specific comparison will be performed; all factors will be summarised separately.


Efficacy outcomes

  • Overall survival

  • Response (complete response, partial response)

  • Treatment-related mortality

  • Progression-free survival

  • Quality of life

Safety outcomes

  • Severe ICANS, drug treatment for ICANS

  • CRS, drug treatment for CRS

  • Prolonged neutropenia, grade 3-4

  • Infections, grade 3-4

  • B-cell aplasia

  • Hypogammaglobulinaemia


Timing of prediction

  • At decision for CAR T-cell therapy

  • At start of therapy

Prediction horizon

  • Any future time point (longer follow-up times preferred if multiple reported)


  • Any setting

CAR: chimeric antigen receptor; CRS: cytokine release syndrome; DLBCL: diffuse large B-cell lymphoma; FL: follicular lymphoma; HGBCL: high-grade B-cell lymphoma; ICANS: immune effector cell-associated neurotoxicity syndrome; PMBCL: primary mediastinal large B-cell lymphoma

This is a protocol.