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Clinical Trial 20415

Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT04182204

Phase: Phase III
Principal Investigator: Sandoval-Sus, Jose

Call 813-745-6100
or 1-800-679-0775 Learn More

Overview

Study Title

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating The Safety And Efficacy Of Polatuzumab Vedotin In Combination With RituximabI Plus Gemcitabine Plus Oxaliplatin (R-Gemox) Versus R-Gemox Alone In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Summary

This study is currently being conducted at Moffitt's Memorial Healthcare site in Hollywood, Florida. This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial.

Objective

To evaluate the safety and tolerability of Pola-R-GemOx as a combination therapy, To evaluate the efficacy of Pola-R-GemOx compared with R-GemOx alone

Treatments

Therapies

Medications

Inclusion Criteria

Inclusion Criteria:

Histologically-confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS) or history of transformation of indolent disease to DLBCL

Relapsed disease (disease that has recurred following a response that lasted ≥ 6 months from completion of the last line of therapy) or refractory disease (disease that progressed during therapy or progressed within 6 months (> At least one (≥ 1) line of prior systemic therapy:

Patients may have undergone autologous hematopoietic stem cell transplantation (HSCT) prior to recruitment; chemotherapy followed by consolidative autologous HSCT will be counted as one line of therapy

Patients may have undergone allogeneic HSCT prior to recruitment, so long as they are off all immunosuppressive therapy and have no active GVHD; chemotherapy followed by allogeneic HSCT will be counted as one line of therapy

Local therapies (e.g., radiotherapy) will not be considered as lines of treatment

At least one bi-dimensionally measurable lesion, defined as > 1.5 cm in its longest dimension as measured by CT or MRI

Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2

Adequate hematological function

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs

For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.

Exclusion Criteria

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products

Contraindication to rituximab, gemcitabine or oxaliplatin

Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0

Prior use of polatuzumab vedotin or a gemcitabine plus platinum-based agent combination, recent participation in a clinical trial, and/or treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy within 2 weeks

Planned autologous or allogenic stem cell transplantation at time of recruitment

Primary or secondary central nervous system (CNS) lymphoma

Richter's transformation or prior CLL

Abnormal laboratory values or health conditions, as assessed by the investigator, any known conditions preventing adherence to protocol or active bacterial, viral, fungal, mycobacterial, parasitic, or other infection

Vaccination with a live vaccine within 4 weeks prior to treatment

Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis

Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications

Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug

Women of childbearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.