Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00622388
First received: February 13, 2008
Last updated: July 3, 2014
Last verified: June 2013

February 13, 2008
July 3, 2014
December 2007
May 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Objective Response [ Time Frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months. ] [ Designated as safety issue: No ]
    Objective response of ofatumumab treatment was assessed according to the "revised response criteria for malignant lymphoma." Participants with objective response were defined as responders with complete remission (CR) or partial remission (PR) of disease. CR is defined as the disappearance of all evidence of disease, and PR is defined as the regression of measurable disease with no new sites of disease.
  • Number of Participants Classified as Responders and Non-responders for Objective Response [ Time Frame: 6-month period from start of treatment (up to Week 24). Participants were followed up for an average of 2.8 months. ] [ Designated as safety issue: No ]
    According to the "revised response criteria for malignant lymphoma," responders included participants with CR and PR, and non-responders included participants with stable disease (SD) and progressive disease (PD). Participants not evaluable (NE) were also considered to be non-responders. PD is defined as any new lesion or an increase by more than or equal to 50% of previously involved sites from baseline. SD is defined as failure to attain CR, PR, or PD.
To investigate the efficacy of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant [ Time Frame: Objective response as measured over a 6 month period from start of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00622388 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ] [ Designated as safety issue: No ]
    The duration of response was defined as the time from the initial response (CR or PR) to the time of relapse, progression, or death. If the participant was lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. However, in cases in which the participant was withdrawn due to ineffective therapy, the withdrawal date was considered as the relapse or progression date.
  • Progression-free Survival (PFS) [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ] [ Designated as safety issue: No ]
    PFS was defined as the time from treatment start until progression or death.
  • Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy [ Time Frame: From date of randomization of the first participant to when the last participant completed the 6-month follow up visit. Participants were followed up for an average of 2.8 months. ] [ Designated as safety issue: No ]
    Time to next DLBCL therapy was defined as the time from the first infusion date to the time of the first administration of the next DLBCL treatment other than ofatumumab. If the participants were lost to follow-up, the endpoint was censored, and the censoring date was the date of the last attended visit at which the endpoint was assessed. However, in cases in which the participant was withdrawn due to ineffective therapy, the withdrawal date was to be considered as the next DLBCL therapy date.
  • Overall Survival (OS) [ Time Frame: Participants were followed up for an average of 2.8 months ] [ Designated as safety issue: No ]
    Overall survival is defined as the time from first infusion to death. It is not possible to analyze data for this outcome measure at this time due to the short follow up period. Data will be analyzed and reported when all participants have completed the trial.
  • Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18 [ Time Frame: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24) ] [ Designated as safety issue: No ]
    HAHA are indicators of immune response to ofatumumab. Blood samples were collected from participants at Visits 1, 12, 13, 14, and 18 and analyzed in batches. The number of participants with positive results at each visit is reported.
  • Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits [ Time Frame: Baseline and Visit 10 (Week 8), Visit 11 (Week 11), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), Visit 15 (Month 15), Visit 16 (Month 18), Visit 17 (Month 21), Visit 18 (Month 24) ] [ Designated as safety issue: No ]
    Malignant B cells (CD45+CD19+ and CD45+CD20+) were measured in peripheral blood samples by flow cytometry. Percent change from Baseline = (value at the indicated visits minus the value at Baseline divided by the value at Baseline) * 100.
  • Number of Participants Who Experienced at Least One Adverse Event (AE) [ Time Frame: Participants were followed up for an average of 2.8 months from start of treatment. ] [ Designated as safety issue: No ]
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment. The protocol-defined AE reporting period was from the first infusion (Visit 2/Week 0) to Visit 18 (Month 24 of follow-up) or time of withdrawal (treatment and follow-up).
  • Percent Change From Screening in Complement (CH50) Levels [ Time Frame: Screening and post-baseline visits (last visit was to occur 24 months post first dose) ] [ Designated as safety issue: No ]
    CH50 was mistakenly registered as an outcome measure with the protocol record. Samples were not collected, and no analysis will take place. Thus, no data will be reported for this outcome measure.
  • AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ] [ Designated as safety issue: No ]
    AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-168) is the AUC from the start of infusion to 168 hours after the start of the infusion; AUC(0-inf) is the AUC from the start of infusion extrapolated to infinity.
  • Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions [ Time Frame: Visit 2 (Week 0) and Visit 9 (Week 7) ] [ Designated as safety issue: No ]
    Cmax is defined as the maximum concentration of drug in serum samples. Ctrough is defined as the minimum observed concentration prior to the start of the next dose. No drug is present prior to the first infusion; therefore, there are no Ctrough results for the first dose.
  • Half-life (T1/2) for Ofatumumab at the Eighth Infusion [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ] [ Designated as safety issue: No ]
    t1/2 is defined as terminal half-life and is the time required for the amount of drug in the body to decrease by half.
  • Clearance (CL) of Ofatumumab at the Eighth Infusion [ Time Frame: Visit 9 (Week 7; up to 11 months after last dose) ] [ Designated as safety issue: No ]
    CL is the clearance of drug from serum, which is defined as the volume of serum from which the drug is cleared per unit time.
  • Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion [ Time Frame: Visit 9 (Week 7; up to 11 months after the last dose) ] [ Designated as safety issue: No ]
    Vss is the volume of distribution at steady state of ofatumumab.
To determine the safety and pharmacokinetic profile of ofatumumab in patients with relapsed DLBCL ineligible for transplant or relapsed after autologous transplant [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Ofatumumab in Patients With Relapsed/Progressive Diffused Large B-Cell Lymphoma (DLBCL) Ineligible for or Relapse/Progression After Transplant
An Open-label, Single-arm. Multi-center Phase 2 Trial With Ofatumumab in Patients With Relapsed/Progressive Diffuse Large B-Cell Lymphoma (DLBCL) Ineligible for Transplant or Relapse/Progression After Autologous Transplant

The purpose of this trial is to determine the effect of ofatumumab in patients with Diffused Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma, Large-Cell, Diffuse
Drug: Ofatumumab
8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg
Experimental: Ofatumumab
8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
Intervention: Drug: Ofatumumab
Coiffier B, Radford J, Bosly A, Martinelli G, Barca G, Davies A, Decaudin D, Gallop-Evans E, Padmanabhan-Iyer S, Van Eygen K, Wu KL, Gupta IV, Lin TS, Goldstein N, Jewell RC, Winter P, Lisby S; 415 study investigators. A multicentre, phase II trial of ofatumumab monotherapy in relapsed/progressive diffuse large B-cell lymphoma. Br J Haematol. 2013 Nov;163(3):334-42. doi: 10.1111/bjh.12537. Epub 2013 Aug 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
81
August 2014
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with DLBCL

  • and relapse after complete remission or disease progression after partial remission who are ineligible for autologous stem cell transplantation
  • and relapse after complete remission or disease progression after partial remission following autologous stem cell transplantation.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00622388
111776, GEN415
Yes
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP