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

NCT00494780 | Completed Phase 2 Results DMC

• 3 other identifiers: 111775Hx-CD20-409The MUNIN trial
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Lymphoma, Follicular

Keywords

CHOP (cyclophosphamide,doxorubicin,vincristine,prednisolone); ofatumumab

Outcome Measures

Primary Outcomes (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).

  Maximum of 23 months after the start of treatment

Secondary Outcomes (15)

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

  Maximum of 23 months after the start of treatment

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

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

• Time to New Anti-follicular Lymphoma (FL) Therapy

  Followed up to 5 years

• Progression-Free Survival (PFS)

  Followed up to 5 years

• Duration of Response

  Followed up to 5 years

Study Arms (2)

Active Comparator 1

ACTIVE COMPARATOR

Each 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

Drug: Ofatumumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone, Prednisone or equivalent

Active Comparator 2

ACTIVE COMPARATOR

Each 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

Drug: Ofatumumab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisolone, Prednisone or equivalent

Interventions

Ofatumumab DRUG

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

Active Comparator 1; Active Comparator 2

Cyclophosphamide DRUG

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

Also known as: CHOP

Active Comparator 1; Active Comparator 2

Doxorubicin DRUG

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

Also known as: CHOP

Active Comparator 1; Active Comparator 2

Vincristine DRUG

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

Also known as: CHOP

Active Comparator 1; Active Comparator 2

Prednisolone, Prednisone or equivalent DRUG

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

Also known as: CHOP

Active Comparator 1; Active Comparator 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• 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.

  PMID: 22409295 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

ofatumumab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisolone; Prednisone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2007
• First Posted: July 2, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: September 1, 2010
• Last Updated: July 11, 2014
• Results First Posted: August 26, 2011

Record last verified: 2014-05

Locations

US (1)