Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma

NCT ID: NCT05498220

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2026-11-07

Brief Summary

This study aimed to evaluate the efficacy of a novel regimen consisting of polatuzumab vedotin in combination with rituximab, gemcitabine, dexamethasone, and cisplatin (PV-RGDP) for the treatment of diffuse large B-cell lymphoma that either came back or did not improve after the treatments (rrDLBCL).

This combination has not been approved by the Food and Drug Administration (FDA) for the treatment of rrDLBCL. Salvage therapy (treatment after standard treatment failed) needs to be improved. Rituximab, gemcitabine, dexamethasone, and cisplatin combination is a standard therapy for rrDLBCL and polatuzumab vedotin (PV) is a novel antibody-drug conjugate targeting CD79b. PV has shown efficacy in the setting of rrDLBCL and can improve the response rates of standard salvage therapy.

This study will focus on subjects in the first relapse (one prior regimen) and will include both subjects who are transplant eligible and those who are transplant ineligible.

Conditions

Diffuse Large B-cell Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single Arm

The subjects with diffuse large B-cell lymphoma were relapsed or refractory after the first treatment and receiving the study protocol treatment.

Group Type: EXPERIMENTAL

Polatuzumab vedotin (PV)

Intervention Type: DRUG

1.8 mg/kg, intravenous, at day 1, in every 21 days

Rituximab

Intervention Type: DRUG

375 mg/m2 intravenous, at day 1 or day 2, in every 21 days

Hyaluronidase

Intervention Type: DRUG

1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days

Gemcitabine

Intervention Type: DRUG

1,000 mg/m2 intravenous at day 1 and 8, in every 21 days

Cisplatin

Intervention Type: DRUG

75 mg/m2, intravenous, at day 1, in every 21 days

Dexamethasone

Intervention Type: DRUG

40 mg intravenous at day 1, Per oral days at days 2-4

GCSF

Intervention Type: DRUG

granulocyte-colony stimulating factor (GCSF )

Interventions

Polatuzumab vedotin (PV)

1.8 mg/kg, intravenous, at day 1, in every 21 days

Intervention Type: DRUG

Rituximab

375 mg/m2 intravenous, at day 1 or day 2, in every 21 days

Intervention Type: DRUG

Hyaluronidase

1,400 mg/23,400 units sub-cutaneous, starts at cycle 2, in every 21 days

Intervention Type: DRUG

Gemcitabine

1,000 mg/m2 intravenous at day 1 and 8, in every 21 days

Intervention Type: DRUG

Cisplatin

75 mg/m2, intravenous, at day 1, in every 21 days

Intervention Type: DRUG

Dexamethasone

40 mg intravenous at day 1, Per oral days at days 2-4

Intervention Type: DRUG

GCSF

granulocyte-colony stimulating factor (GCSF )

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.

2. Biopsy proven diffuse large B-cell lymphoma (DLBCL) in the first relapse (biopsy can be from initial diagnosis). The study will allow high-grade B cell lymphoma, but not including Burkitt's lymphoma.

3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.

4. Radiologic evidence of active disease within 28 days of starting trial therapy.

5. Only one prior line of therapy.

6. Prior cancer treatment must be completed at least 14 days prior to the start of treatment and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to ≤ Grade 1 or start of treatment.

7. Subjects may be eligible or ineligible for autologous stem cell transplant

Exclusion Criteria

1. Known severe, active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment that may put the subject at undue risk as determined by the investigator.

2. Subjective hearing loss interfering with daily activities or evidence of greater than mild hearing loss compared to age appropriate normal on screening audiometry are excluded.

3. Women who are pregnant or breastfeeding or who intend to become pregnant within a year of the last dose of study treatment.

4. Subjects with a history of prior or concurrent second primary malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the study drugs are eligible for enrollment in the trial.

5. Previous exposure to polatuzumab vedotin.

6. History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine.

7. Contraindication to gemcitabine or cisplatin, or dexamethasone or similar corticosteroid.

8. Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction < 40%, symptomatic coronary artery disease or symptomatic arrhythmias.

9. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher Dittus, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Division of Hematology | Lymphoma Program Lineberger Comprehensive Cancer Center

Locations

Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Countries

United States

Related Links

http://unclineberger.org/patientcare/clinical-trials/clinical-trials

University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Other Identifiers

LCCC2033

Identifier Type: -

Identifier Source: org_study_id