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Lymphoma, Large-Cell, DiffusePhase 2NCT00622388

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

A Phase 2 study testing Ofatumumab in people with Lymphoma, Large-Cell, Diffuse, run by GlaxoSmithKline at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Large-Cell, Diffuse
What is being tested?
Ofatumumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited Kingdom
Study dates
Dec 2007to Aug 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • GSK Investigational Site

    London, London, EC1M 6BQ

Other trials in United Kingdom

About this study

Official title: 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

Being tested
Ofatumumab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabDrug

    8 weekly intra-venous (i.v.) infusions, 1 x 300mg and 7 x 1000mg

Study groups in NCT00622388
Study groupRoleWhat they receive
OfatumumabExperimental8 weekly intra-venous (I.V.) infusions, 1 x 300mg and 7 x 1000mg
Receives: Drug: Ofatumumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Objective Response

    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.

    Measured: 6-month period from start of treatment (up to Week 24)

  2. Number of Participants Classified as Responders and Non-responders for Objective Response

    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.

    Measured: 6-month period from start of treatment (up to Week 24)

Secondary outcomes (13)

  1. Duration of Response

    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.

    Measured: From date of start of treatment to 2 years or withdrawal

  2. Progression-free Survival (PFS)

    PFS was defined as the time from treatment start until progression or death.

    Measured: From date of start of treatment to 2 years or withdrawal

  3. Time to Next Diffuse Large B-Cell Lymphoma (DLBCL) Therapy

    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.

    Measured: From date of start of treatment to 5 years or withdrawal

  4. Overall Survival (OS)

    Overall survival is defined as the time from first infusion to death. Overall survival was a secondary endpoint in the study. However, since many participants withdrew from the study after developing disease progression overall survival could not be reliably estimated.

    Measured: From date of start of treatment to 5 years or withdrawal

  5. Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Screening and at Visits 12, 13, 14, and 18

    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.

    Measured: Screening visit (=<14 days before treatment start), Visit 12 (Month 6), Visit 13 (Month 9), Visit 14 (Month 12), and Visit 18 (Month 24)

  6. Median Percent Change From Baseline in CD45+CD19+ and CD45+CD20+ Cells in the Peripheral Blood at the Indicated Visits

    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.

    Measured: 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), Visit 19 (Month 30), Visit 20 (Month 36)

  7. Number of Participants Who Experienced at Least One Adverse Event (AE)

    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).

    Measured: Time frame is from date of start of treatment to 2 years or withdrawal

  8. Percent Change From Screening in Complement (CH50) Levels

    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.

    Measured: Screening and post-baseline visits (last visit was to occur 24 months post first dose)

  9. AUC(0-inf) and AUC(0-168) for Ofatumumab at the Eighth Infusion

    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.

    Measured: Visit 9 (Week 7; up to 11 months after last dose)

  10. Cmax and Ctrough for Ofatumumab at the First and Eighth Infusions

    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.

    Measured: Visit 2 (Week 0) and Visit 9 (Week 7)

  11. Half-life (T1/2) for Ofatumumab at the Eighth Infusion

    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.

    Measured: Visit 9 (Week 7; up to 11 months after last dose)

  12. Clearance (CL) of Ofatumumab at the Eighth Infusion

    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.

    Measured: Visit 9 (Week 7; up to 11 months after last dose)

  13. Volume of Distribution at Steady State (Vss) of Ofatumumab at the Eighth Infusion

    Vss is the volume of distribution at steady state of ofatumumab.

    Measured: Visit 9 (Week 7; up to 11 months after the last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2010
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00622388
Sponsor's protocol ID
111776
Other IDs
GEN415
Status last verified
Jan 2015
First submitted
13 Feb 2008
Last updated
24 Jul 2015
Data monitoring committee
Yes

Publications

  • Coiffier B, Radford J, Bosly A, Martinelli G, Verhoef 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.

    PubMed 24032456

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab in people with Lymphoma, Large-Cell, Diffuse, run by GlaxoSmithKline at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Objective Response (time frame: 6-month period from start of treatment (up to Week 24)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00622388, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2015.

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