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.

Population

• 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

Comparator(s)

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

Outcome(s)

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

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)

Setting

• 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