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A Phase II Trial of 4 vs 6 Cycles of CHP Combined With Polatuzumab Vedotin-Rituximab in Untreated DLBCL Patients With IPI 0-1

ConditionDLBCL - Diffuse Large B Cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

This is an open-label, multicentre, randomized phase II non-inferiority trial aiming to compare the efficacy and safety of 4 versus 6 cycles of CHP (administered at 21-day intervals), both in combination with 6 cycles of polatuzumab vedotin and rituximab, in previously untreated patients with diffuse large B-cell lymphoma (DLBCL) and an International Prognostic Index (IPI) score of 0-1. The study's primary objective is to determine if shorter CHP duration can achieve comparable outcomes to the standard 6-cycle regimen when combined with polatuzumab vedotin and rituximab

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL)

Age ≥18yo and ≤80yo at the time of signing consent

International Prognostic Index (IPI) score 0-1

ECOG 0-2

Disqualifiers

Patients with central nervous system or primary mediastinal lymphoma, and patients with transformed lymphoma.

Patients with uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, etc.

Pregnant or lactating women.

Known history of human immunodeficiency virus (HIV) or active hepatitis C virus (HCV; positive by RNA polymerase chain reaction [PCR]) infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Polatuzumab Vedotin

    Drug

    Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

  • Rituximab

    Drug

    Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

  • Cyclophosphamide

    Drug

    Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm

  • Doxorubicin

    Drug

    Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

  • Prednisone

    Drug

    Prednisone PO will be administered as per the schedule specified in the respective arm.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: 4×Pola-RCHP followed by 2×Pola-RExperimental treatment 5 interventions
Group B: 6×Pola-RCHPActive comparator 5 interventions

Trial outcomes

Primary outcomes

1

Complete response rate (CR)

To assess the complete response rate (CR) at the end of treatment with Treatment

Time frame
up to the end of 6 cycles of treatment (each cycle is 28 days)]

Secondary outcomes

1

Overall Response Rate (ORR)

Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment

Time frame
up to the end of 6 cycles of treatment (each cycle is 28 days)
2

Duration of Response (DoR)

The length of time between the achievement of criteria for response to treatment (first documented complete or partial response) and the first documented relapse or progression.

Time frame
up to 2 years
3

Progression-free survival (PFS)

The time from the enrollment of a subject to the occurrence of (in any way) progression of disease or Death for any reason. patients with indeterminate recurrence or Death at the last follow-up, defined as the date of the last Investigation

Time frame
up to 2 years
4

To identify biomarkers

To identify biomarkers that may predict response to a combination regimen, biomarkers associated with progression to a more severe disease state, biomarkers that are sensitive to the development of Adverse event, biomarkers that provide evidence of the activity of the combination, or biomarkers that may enhance the understanding or understanding of the biology of the disease.

Time frame
up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: