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Lymphoma, FollicularPhase 2MUNINNCT00494780

Ofatumumab (Humax-CD20) With CHOP (Cyclophosphamide,Doxorubicin, Vincristine, Predisolone) in Follicular Lymphoma (FL) Patients

A Phase 2 study testing Ofatumumab, Cyclophosphamide and Doxorubicin in people with Lymphoma, Follicular, run by GlaxoSmithKline at 1 site in United States.

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

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular
What is being tested?
Ofatumumab, Cyclophosphamide and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteUnited States
Study dates
Jun 2007to Sep 2010
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

  • Patient with Follicular Lymphoma (FL)
  • Confirmed diagnosis of Follicular lymphoma
  • 18 years or above
  • Verbal and written information about the study

Who cannot join

  • No previous treatment for Follicular Lymphoma
  • Clinical suspicion that the Follicular Lymphoma has transformed to aggressive lymphoma
  • Several diseases such as malignancies etc.
  • Screening laboratory values
  • Current participation in any other interventional clinical study
  • Breast feeding women or pregnant women
  • Women of childbearing potential not willing to use adequate contraception

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Being tested
Ofatumumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisolone, Prednisone or equivalent
Keywords
CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone), ofatumumab
Medical subject headings
Lymphoma, Follicular

What participants receive

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

  • OfatumumabDrug

    ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given

  • CyclophosphamideDrug

    Also called CHOP

    Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

  • DoxorubicinDrug

    Also called CHOP

    Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start

  • VincristineDrug

    Also called CHOP

    Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

  • Prednisolone, Prednisone or equivalentDrug

    Also called CHOP

    100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start

Study groups in NCT00494780
Study groupRoleWhat they receive
Active Comparator 1Active comparatorEach patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 500mg
Receives: Drug: Ofatumumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone, Prednisone or equivalent
Active Comparator 2Active comparatorEach patient will receive a total of 6 infusions with ofatumumab in combination with CHOP every 3 weeks. The first infusion will be 300mg followed by 5 infusions of 1000mg
Receives: Drug: Ofatumumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone, Prednisone or equivalent

What is being measured

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

  1. Number of Participants With the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab)

    Based on standardized response criteria for NHL, responders included participants with CR (complete disappearance of all detectable clinical and radiographic evidence of disease), CRu (more than a 75% decrease in LN size compared to baseline), and PR (>=50% decrease in LN size and evidence of new lesions). Non-responders included participants with stable disease (SD; <50% decrease in LN size from baseline) and progressive disease (PD; >=50% increase in LN size and evidence of new lesions).

    Measured: Maximum of 23 months after the start of treatment

Secondary outcomes (15)

  1. Number of Participants With Complete Remission (CR) at Visit 26

    Participants were evaluated for response by an Independent Endpoint Review Committee in accordance with the standardized response criteria for NHL. Participants with CR were defined as those with the complete disappearance of all detectable clinical and radiographic evidence of disease.

    Measured: Maximum of 23 months after the start of treatment

  2. Median Percent Change From Visit 1 (Screening, Week -2) in Tumor Size at Visit 33 (24 Months After the Last Infusion of Ofatumumab)

    The tumor size for a participant was computed as the sum of product of diameters (SPD) for the indicator lesions. Reduction in tumor size was calculated as percent change from Visit 1 until Visit 33, separately by radiologist 1 and radiologist 2. Percent change from Visit 1 (Screening, Week -2) = (value at Visit 33 minus value at Visit 1 divided by value at Visit 1) * 100.

    Measured: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

  3. Time to New Anti-follicular Lymphoma (FL) Therapy

    Time to new FL therapy is defined as the time from randomization until the time of first administration of the new FL therapy other than ofatumumab. Time to new FL therapy will be censored if participants are lost to follow-up. The censoring date in such cases will be the date of the last attended visit at which the endpoint was assessed.

    Measured: Followed up to 5 years

  4. Progression-Free Survival (PFS)

    PFS is defined as the time from randomization until progression or death.

    Measured: Followed up to 5 years

  5. Duration of Response

    The duration of response is defined as the time from the initial response (the first visit at which response was observed) to progression or death.

    Measured: Followed up to 5 years

  6. Percent Change From Visit 1 (Screening) in Peripheral CD19+ and CD20+ Cell Counts at Visit 33 (24 Months After the Last Infusion of Ofatumumab)

    The peripheral blood for each participant was collected and analyzed for CD19+ and CD20+ cell counts. CD19+ and CD20+ are B-cell types which are used as an index of a participant's response to treatment.

    Measured: Maximum of 24 months after the last infusion of Ofatumumab (Visit 33; median of 33.8 months)

  7. Number of Participants Who Experienced Any Adverse Event (AEs) From First Treatment to Visit 33 (24 Months After Last Infusion)

    An adverse event is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. A list of AEs experienced in the study with a frequency threshold of 5% can be found in the AE section.

    Measured: Up to 22 months after study start

  8. Number of Participants With Positive Human Anti-human Antibodies (HAHA) at Visits 1, 28, and 33

    HAHA are indicators of immunogenicity to ofatumumab. Blood samples were drawn from participants at Visits 1, 28, and 33 for analysis of HAHA.

    Measured: Visits 1 (Screening), 28 (9 months after last dose), and 33 (24 months after last dose)

  9. Median Percent Change From Visit 1 (Screening) in Serum Complement (CH50) Levels at Visit 22

    The peripheral blood for each participant was collected and analyzed for serum complement CH50 levels. Cluster of Differentiation index 50 (CD50) is a human gene which is used as an index of immune response. CD50Percent change from Visit 1 (Screening, Week -2) = (value at Visit 22 minus value at Visit 1 divided by value at Visit 1) * 100.

    Measured: Visit 1 (Screening, Week -2) and Visit 22 (Week 15)

  10. Number of Participants Who Had a Conversion of BCL-2 t(14;18)-Positive to Negative by Polymerase Chain Reaction (PCR) in Peripheral Blood and Bone Marrow Aspirate and Its Durability Post-therapy

    This is a genetic prognostic marker of FL response. The former sponsor decided to not analyze these samples; therefore, no results are presented.

    Measured: Maximum of 6 years follow-up

  11. Cmax and Ctrough at the Sixth Infusion (Week 15, Visit 22)

    Cmax is defined as the maximum concentration of drug in plasma samples. Ctrough is defined as the trough plasma concentration (measured concentration at the end of a dosing interval [taken directly before next administration]).

    Measured: Week 15 (Visit 22)

  12. AUC(0-inf) and AUC(0-504) After the Sixth Infusion (Week 15, Visit 22)

    AUC is defined as the area under the ofatumumab concentration-time curve as a measure of drug exposure. AUC(0-504) is AUC from the start of infusion to 504 hours after the start of the infusion; AUC(0-inf) is AUC from the start of infusion extrapolated to infinity.

    Measured: Week 15 (Visit 22)

  13. Half Life (t1/2) of Ofatumumab at the Sixth Infusion (Week 15, Visit 22)

    Half life is defined as the period of time required for the amount of drug in the body to be reduced by half.

    Measured: Week 15 (Visit 22)

  14. CL After the Sixth Infusion (Week 15, Visit 22)

    CL is the clearance of drug from plasma, which is defined as the volume of plasma from which the drug is cleared per unit time.

    Measured: Week 15 (Visit 22)

  15. Vss at the Sixth Infusion (Week 15, Visit 22)

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

    Measured: Week 15 (Visit 22)

Timeline

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

  1. First posted2 Jul 2007 (estimated)
  2. Study startJun 2007
  3. Primary completionApr 2009
  4. Study completionSep 2010

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00494780
Sponsor's protocol ID
111775
Other IDs
Hx-CD20-409, The MUNIN trial
Acronym
MUNIN
Status last verified
May 2014
First submitted
29 Jun 2007
Last updated
11 Jul 2014
Data monitoring committee
Yes

Publications

  • Czuczman MS, Hess G, Gadeberg OV, Pedersen LM, Goldstein N, Gupta I, Jewell RC, Lin TS, Lisby S, Strange C, Windfeld K, Viardot A; 409 Study Investigators. Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma. Br J Haematol. 2012 May;157(4):438-45. doi: 10.1111/j.1365-2141.2012.09086.x. Epub 2012 Mar 13.

    PubMed 22409295

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ofatumumab, Cyclophosphamide and Doxorubicin in people with Lymphoma, Follicular, run by GlaxoSmithKline at 1 site in United States.

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 4 inclusion and 7 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 11 Jul 2014. 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 States. 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 26 Aug 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 the Indicated Overall Best Response (OBR) at Visit 26 (3 Months After the Last Infusion of Ofatumumab) (time frame: Maximum of 23 months after the start of treatment). 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 NCT00494780, 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 11 Jul 2014.

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