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Completed

NCT Number: NCT01419665

GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL)

The purpose of this study is to demonstrate comparability of the ORR in patients with previously untreated, advanced stage FL who receive GP2013-treatment to patients who receive MabThera-treatment.

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Key information

Conditions

Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative site, La Plata, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with previously untreated advanced stage, CD20-positive FL
  • Patient with ECOG performance status 0, 1 or 2.

Exclusion criteria

  • Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a
  • Patient who has previously received any prior therapy for lymphoma
  • Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal).
  • Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer.

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

GP2013

Biological

Type: Biological/Vaccine

Other names: no brand name available

Rituximab

Biological

Type: Biological/Vaccine

Other names: MabThera(R)

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 24 weeks

    ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.

Secondary outcomes

  1. To Evaluate the Complete Response (CR) Rate During the Combination Treatment Period

    Time frame: 24 weeks

  2. To Evaluate the Partial Response (PR) Rate During the Combination Treatment Period

    Time frame: 24 weeks

  3. To Evaluate the Progression Free Survival (PFS) With up to 3 Years of Follow-up Post Randomization

    Time frame: 3 years

    Number of participants with progression free survival events

  4. To Evaluate the Overall Survival (OS) With up to 3 Years of Follow-up Post Randomization, as Assessed by the Number of Deaths

    Time frame: 3 years

    OS was defined as the time from date of randomization to date of death due to any cause. If a patient was not known to have died, OS was censored at the date of last contact including survival follow-up.

  5. To Evaluate the Incidence of Immunogenicity (ADA Formation) Against GP2013 and MabThera (Rituximab)

    Time frame: 24 weeks, 3 years

    number of participants with confirmed positive ADA

  6. To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Max)

    Time frame: day 63

    C max

    For descriptive purposes only, no hypothesis testing

  7. To Evaluate a PK Marker Following the Treatment With GP2013-Chemotherapy and MabThera-Chemotherapy (C Trough)

    Time frame: day 63

    C through

    For descriptive purposes only, no hypothesis testing

  8. To Evaluate a PD Marker (Peripheral CD19+ B-cell Counts) Following the Treatment With GP2013 + Chemotherapy Amd MabThera- Chemotherapy

    Time frame: 21 days

    AUEC (0-21d)

    For descriptive purposes only, no hypothesis testing

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Collaborators

  • Novartis Pharmaceuticals

Registry information

Official study title

A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 vs. MabThera® in Patients With Previously Untreated, Advanced Stage Follicular Lymphoma

Acronym: ASSIST_FL

Important dates

Study start
2011
Primary completion
2015
Study completion
2018
First posted
Aug 18, 2011
Registry last updated
May 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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