No longer a GSK study

Study Description:

This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

The purpose of this study is to evaluate the safety and efficacy of ofatumumab added to chlorambucil in patients with untreated Chronic Lymphocytic Leukemia.

GSK Study ID:

OMB110911


Has Results Document Available
ClinicalTrials.gov Identifier:

NCT00748189


EudraCT Number:

2008-004932-19


Study Overview

Medical Conditions

Leukaemia

Product

chlorambucil;ofatumumab

Collaborators

N/A


Date

December 2008 to June 2022

Type

Interventional

Phase

2/3


Gender

Both

Age

18 Year+

Accepts Healthy Volunteers

none


This study has Protocol summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    Not available

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]


Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Safety/Efficacy Study
  • Masking: Not Available
  • Masked Subject: No
  • Masked Caregiver: No
  • Masked Investigator: No
  • Masked Assessor: No
Primary Outcomes:

  • Progression-Free Survival (PFS), as assessed by the Independent Review Committee (IRC)
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

Secondary Outcomes:

  • Duration of response (DOR), as assessed by the IRC
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Time to next therapy
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Dose-normalized AUC(0-6) and AUC(0-inf) of chlorambucil and dose-normalized AUC(0-6) of phenylacetic acid mustard (PAAM)
    Timeframe: Cycle 3 Day 1

  • Change from Baseline in health related quality of life (HRQOL)
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Number of participants with the best overall response (OR), as assessed by the IRC
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Vss of ofatumumab
    Timeframe: Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1

  • Number of participants who were negative for minimal residual disease (MRD)
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Number of participants with any adverse event (AE) or serious adverse event (SAE)
    Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)

  • Cmax and Ctrough of ofatumumab
    Timeframe: Cycle 1 Day 1,Cycle 1 Day 8, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1, and Cycle 9 Day 1

  • Number of participants who recived no transfusion or at least one transfusion during the study
    Timeframe: From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)

  • Number of participants with at least one Grade 3/Grade 4 myelosuppression (anemia, neutropenia, and thrombocytopenia)
    Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)

  • Number of participants with a human anti-human antibody (HAHA) positive result
    Timeframe: Baseline, Cycle 4 Day 1, 1 Month Follow-up, and 6 Month Follow-up

  • Number of participants with autoimmune hemolytic anaemia (AIHA) disease
    Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)

  • Total plasma clearance (CL) of ofatumumab
    Timeframe: Cycle 4 Day 1

  • Overall Survival
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Mean change from Baseline in the Immunoglobulin (Ig) antibodies IgA, IgG, and IgM
    Timeframe: From start of treatment to the last study visit/withdrawal visit (Median follow-up approximately 29.3 months)

  • AUC(0-tau) of ofatumumab
    Timeframe: Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 4 Day 1

  • Time to response, as assessed by the IRC
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Time to progression, as assessed by the IRC
    Timeframe: From randomization until the 259th PFS event occurred (Median follow-up approximately 29.3 months)

  • Number of participants with improvement in ECOG performance status of 0 or 1, as assessed by the IRC
    Timeframe: Baseline, Cycle 3 Day 1, 1 month Follow-up

  • Plasma half life (t1/2) of ofatumumab
    Timeframe: Cycle 4 Day 1

  • Number of participants with improvement in constitutional symptoms (CS)
    Timeframe: Baseline, Cycle 3 Day 1, and 1 month Follow-up

  • Dose-normalized Cmax of chlorambucil and phenylacetic acid mustard (PAAM)
    Timeframe: Cycle 3 Day 1

  • Number of participants with AEs and SAEs of maximum severity of grade 3 or higher
    Timeframe: From the first dose of study medication to 60 days after the last dose of study medication and until follow-up for SAEs unless initiation of subsequent anti-CLL therapy (Median follow-up approximately 29.3 months)

Interventions:

  • drug: chlorambucil, tablets
  • drug: ofatumumab (GSK1841157) infusion

Keyword:

  • Oncology, Untreated, Efficacy, Safety, Chronic Lymphocytic Leukemia, Ofatumumab, Chronic Lymphocytic Leukemia (CLL), untreated
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 447

Clinical Publications:

  • Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F, COMPLEMENT 1 Study Investigators.Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial.Lancet.2015;385(9980):1873-83
  • Roxanne C. Jewell, Kevin Laubscher, Eric Lewis, Lei Fang, Zarina Gafoor, Jodi Carey, Astrid McKeown, Sarah West, Oliver Wright, Donna Sedoti, Iestyn Dixon, Scott Hottenstein, and Geoffrey Chan.Assessment of the Effect of Ofatumumab on Cardiac Repolarization.J Clin Pharmacol.2015;55(1):114-121