NCT00811733

Brief Summary

Given the tolerability and efficacy of ofatumumab in follicular lymphoma and Chronic Lymphocytic Leukemia, and the need to improve therapy for patients with WM utilizing a non-myelosuppressive agent this phase II trial of ofatumumab is being initiated in patients with Waldenstrom's Macroglobulinemia (WM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Longer than P75 for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 30, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

May 30, 2017

Status Verified

March 1, 2015

Enrollment Period

2.3 years

First QC Date

December 18, 2008

Results QC Date

February 9, 2012

Last Update Submit

April 28, 2017

Conditions

Waldenstrom Macroglobulinaemia

Keywords

Waldenstrom's MacroglobulinemiaOfatumumab

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Overall Response (OR) for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator

    OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.

    Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment

  • Number of Participants With OR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator

    OR (based on the Consensus Panel recommendations from the 2nd and 3rd International Workshop on WM) included Complete Response (CR), Partial Response (PR), or a Minor Response (MR). CR: Complete disappearance of serum monoclonal (SM) Immunoglobulin (Ig) E (IgE), measured centrally; resolution of adenopathy/organomegaly upon physical exam and computerized tomography (CT) scan; lymph nodes =\<1.5 centimeters; absence of malignant cell by bone marrow histologic examination. PR: a \>=50% reduction from baseline in the SM IgM concentration. MR: \>=25%, but a \<50% reduction of SM IgM from baseline.

    Baseline and up to Study Week 16

Secondary Outcomes (19)

  • Number of Participants With CR, PR, and MR for Cycle 1 (Including the Redosing Cycle), as Assessed by the Investigator

    Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment

  • Number of Participants With CR, PR, and MR for Cycle 1 (Excluding the Redosing Cycle), as Assessed by the Investigator

    Baseline and up to Study Week 16

  • Number of Participants With IgM Flare for Cycle 1 Response (Including the Redosing Cycle)

    Baseline and up to 27 months from the first dose of Cycle 1 (Study Day 1), and before Cycle 2 treatment

  • Duration of Response for All Responders (CR, PR, MR), as Assessed by the Investigator

    From baseline up to approximately 5 years

  • Progression-free Survival

    From baseline up to approximately 5 years

  • +14 more secondary outcomes

Study Arms (1)

Ofatumumab

EXPERIMENTAL

Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.

Biological: Ofatumumab

Interventions

OfatumumabBIOLOGICAL

Ofatumumab is a fully human antibody, targeting a unique epitope on the CD20 molecule expressed on human B cells.

Ofatumumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed and active Waldenstrom's Macroglobulinemia requiring treatment.
  • Ambulatory and capable of all selfcare. Up and about more than 50% of waking hours.
  • Adequate organ function.
  • Detectable CD20 positive of the tumor cells.
  • Measurable disease as defined by a monoclonal IgM paraprotein level greater than 1000 mg/dL.

You may not qualify if:

  • Treatment of WM within the past 28 days.
  • Treatment with rituximab or alemtuzamab within the past 3 months.
  • Certain heart problems, chronic or current active infection not controlled with oral antibiotics, other current cancer or within last 5 years.
  • Current participation in another interventional clinical study.
  • Lactating or pregnant women or female patients of child-bearing potential (or male patients with such partners) not willing to use adequate contraception.
  • Active cerebrovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

Los Angeles, California, 90095-6984, United States

Location

GSK Investigational Site

Stanford, California, 94305, United States

Location

GSK Investigational Site

Rochester, Minnesota, 55905, United States

Location

GSK Investigational Site

Buffalo, New York, 14263, United States

Location

GSK Investigational Site

New York, New York, 10021, United States

Location

GSK Investigational Site

Columbus, Ohio, 43210-1228, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Furman RR, Eradat HA, DiRienzo CG, Hofmeister CC, Hayman SR, Leonard JP, Coleman M, Advani R, Chanan-Khan A, Switzky J, Liao QM, Shah D, Jewell RC, Lisby S, Lin TS. Once-weekly ofatumumab in untreated or relapsed Waldenstrom's macroglobulinaemia: an open-label, single-arm, phase 2 study. Lancet Haematol. 2017 Jan;4(1):e24-e34. doi: 10.1016/S2352-3026(16)30166-1. Epub 2016 Dec 1.

    PMID: 27914971DERIVED

MeSH Terms

Conditions

Waldenstrom Macroglobulinemia

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 19, 2008

Study Start

March 1, 2009

Primary Completion

June 1, 2011

Study Completion

February 1, 2014

Last Updated

May 30, 2017

Results First Posted

April 30, 2012

Record last verified: 2015-03

Locations

US(7)