NCT01992653 (Clinical Trial / Polatuzumab Vedotin / DCDS4501A / RG-7596)

Study Title
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin’s Lymphoma (NCT01992653)

Trial Description

This multicenter, open-label, dose-escalation study will evaluate the safety and anti-tumor activity of polatuzumab vedotin (DCDS4501A or RG-7596) in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone in participants with non-Hodgkin’s lymphoma. Cohort of participants will receive escalating doses of polatuzumab vedotin intravenously every 3 weeks in combination with standard doses of rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and oral prednisone.

Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with rituximab-prednisone/prednisolone, cyclophosphamide, and doxorubicin (R-CHP) and obinutuzumab-prednisone/prednisolone, cyclophosphamide, and doxorubicin (G-CHP).

The maximum tolerated dose or MTD of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD is determined, polatuzumab vedotin will be dosed at MTD -1 in combination with G-CHP to start the dose escalation of this combination.

Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP and G-CHP. The MTD of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD is determined, polatuzumab vedotin will be dosed at MTD -1 in combination with G-CHP to start the dose escalation of this combination.

This trial is sponsored by Genentech. [1]

Study Data

• Conditions:
  • B-Cell Lymphoma
  • Non-Hodgkin’s Lymphoma
• Interventions:
  • Drugs used in this trial
    • Cyclophosphamide
    • Doxorubicin (Doxil®; TTY Bio pharmacy Company Limited)
    • Obinutuzumab (Gazyva®,Genentech, Inc.)
    • Polatuzumab Vedotin (DCDS4501A or RG-7596; Genentech/Roche)
    • Prednisone/Prednisolone (Orapred®; Concordia Healthcare Corp.)
    • Rituximab (Rituxam®; Biogen, Inc./ Genentech, Inc.)
• Phase: I
• Estimated Enrollment: 110
• Start: November 2013
• Estimated Completion: February 2020
• Last verified: July 2015

Study Schematic

(Coming soon)

Click here to Return to Drug map

Last Editorial review: July 13, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.

Add to Flipboard Magazine.