NCT01171378

Brief Summary

The purpose of this study is to evaluate Ofatumumab in combination with CHOP (cyclophosphamide, hydroxydaunorubicin (doxorubicin), Oncovin (vincristine), and prednisone/prednisolone, the standard chemotherapy treatment) in induction and maintenance treatment of Richter's Syndrome. This study aims to evaluate the overall response rate to CHOP-O (CHOP in combination with Ofatumumab) according to the Revised Response Criteria for Malignant Lymphoma. The hypothesis would be that treatment with CHOP-O for Richter's Syndrome (RS), shows a difference in overall survival (more people living longer), when compared with the standard treatment of CHOP-R (CHOP chemotherapy plus Rituximab).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_2

Geographic Reach
1 country

9 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

July 22, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2016

Completed
Last Updated

April 25, 2018

Status Verified

April 1, 2018

Enrollment Period

3.8 years

First QC Date

July 22, 2010

Last Update Submit

April 23, 2018

Conditions

Richter's Syndrome

Keywords

Richter's SyndromeHigh-grade transformation in patients with B cell chronic lymphocytic leukemiaFeasibilityOfatumumab Induction and maintenanceCHOPCHOP-0CHOP-ORNon Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

  • Objective response

    Objective response as defined by the revised response criteria for malignant lymphoma (Cheson et al, JCO, Vol 25, No 5, 2007). Patients will be classified as responders/non-responders as follows: complete remission (CR), nodular partial remission (nPR) and partial remission (PR) are classified as responders; while stable disease (SD) and progressive disease (PD) are classified as non-responders. Non-evaluable patients will be classified as non-responders.

    Week 20

Secondary Outcomes (7)

  • Overall survival

    72 weeks

  • Progression free survival

    72 weeks

  • Duration of response

    72 weeks

  • Time to next DLBCL therapy

    72 weeks

  • Reduction in Tumour Size

    13, 20 and 72 weeks

  • +2 more secondary outcomes

Study Arms (1)

Ofatumumab

OTHER

Single arm study

Drug: Ofatumumab

Interventions

OfatumumabDRUG

1000mg vials (50ml @ 20mg/ml), or 100mg vials (5ml @20mg/ml), to be given as an Intravenous (IV) infusion. Ofatumumab will be infused intravenously on day 1 (300 mg), day 8 (1000 mg) and day 15 (1000mg) in the first cycle, followed by infusions every 3 weeks of 1000 mg on the first day of each cycle for a total of 6 cycles. Maintenance treatment will start 4 weeks after day 1 of cycle 6 in week 20 and consists of six infusions of ofatumumab every 8 weeks

Also known as: Arzerra
Ofatumumab

Eligibility Criteria

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

You may qualify if:

  • Signed written informed consent prior to performing any study-specific procedures
  • Patients with B-CLL and newly diagnosed not previously treated and biopsy proven DLBCL Richter's transformation
  • Computerized tomography (CT) scan performed within 6 weeks prior to starting treatment.
  • ECOG (Eastern Cooperative Oncology Group) Performance Status of 0, 1, 2 or 3
  • Age 18 years and over.

You may not qualify if:

  • CHOP or CHOP-like anthracycline containing treatment for DLBCL within 6 months prior to registration.
  • Known central nervous system (CNS) involvement of B-CLL.
  • Any malignancy that requires active treatment with the exception of basal cell carcinoma and non-invasive squamous cell carcinoma.
  • Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis.
  • Subjects meeting any of the following criteria must not be enrolled in the study:
  • Positive serology for Hepatitis B (HB) defined as a positive test for HBsAg (the surface antigen of the Hepatitis-B-Virus). In addition, if negative for HBsAg but HBcAb (Hepatitis B core Antibody) positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded. Consent will be sought prior to any test being performed.
  • Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
  • Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
  • History of significant cerebrovascular disease in last 6 months.
  • Known Human immunodeficiency virus (HIV) positive.
  • Known or suspected hypersensitivity to components of investigational product.
  • Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to Visit 2 (start of treatment, cycle 1, day 1).
  • Current participation in any other interventional clinical study.
  • Patients known or suspected of not being able to comply with a study protocol (e.g. due to alcoholism, drug dependency or psychological disorder).
  • Breast feeding women or women with a positive pregnancy test at screening.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, L7 8XP, United Kingdom

Location

St Bartholomew's Hospital

London, EC1A 7BE, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Eyre TA, Clifford R, Roberts C, Boyle L, Francis A, Schuh A, Dutton SJ. Single arm NCRI phase II study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter's syndrome. BMC Cancer. 2015 Feb 13;15:52. doi: 10.1186/s12885-015-1048-9.

    PMID: 25775024DERIVED

Related Links

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Anna Schuh, MD, PhD, MRCP, FRCPath

    Oxford University Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2010

First Posted

July 28, 2010

Study Start

April 1, 2011

Primary Completion

February 1, 2015

Study Completion

April 19, 2016

Last Updated

April 25, 2018

Record last verified: 2018-04

Locations

GB(9)