Rituximab in Treating Patients With Hodgkin's Lymphoma

March 8, 2017 updated by: Ranjana Advani

Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant Hodgkin's lymphoma. Subjects will receive rituximab by IV infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months.

This was a single-arm study with multiple treatment periods added by amendment (ie, Secondary Group), with results reported by treatment period. As this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the Initial Group vs the Secondary Group.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine
      • Stanford, California, United States, 94305
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  • Age ≥ 3 years
  • Lymphocyte-predominant Hodgkin's disease (LPHD) of B-cell lineage
  • Biopsy-confirmed expression of CD20 antigen
  • At least one tumor mass measuring > 1.0 cm in largest dimension
  • No evidence of active infection
  • Subjects at high risk of Hepatitis B virus (HBV) infection should be screened prior to enrollment.
  • Performance status of 0 to 2
  • Absolute neutrophil count (ANC) > 1500/mL
  • Platelet count > 50,000/mL
  • Serum creatinine (Cr) < 1.5 x upper limit of normal (ULN)
  • Alkaline phosphatase < 2 x ULN, unless related to primary disease
  • Bilirubin < 2 x ULN, unless related to primary disease
  • Aspartate transaminase (AST) and alanine transaminase (ALT) < 2 x ULN, unless related to primary disease
  • Subjects must be able to read and sign Institutional Review Board-approved informed consent

EXCLUSION CRITERIA

  • Life expectancy at least 12 weeks
  • Evidence of other active malignancies other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin
  • Active HBV infection or hepatitis.
  • Serious non-malignant disease (eg, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections)
  • Concomitant or treatment within prior 4 weeks with radiotherapy or chemotherapy (within prior 6 weeks for nitrosourea compounds)
  • Concurrent treatment with prednisone or other systemic steroid medication
  • Treatment with any investigational drug within 30 days prior to entry into the study
  • Treatment with any investigational drug within 5 half-lives of that drug prior to entry into the study
  • Major surgery, other than diagnostic surgery, within 4 weeks
  • Any other conditions which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives
  • Female patients must be of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab 375 mg/m2 per week

375 mg/m2 rituximab by IV infusion weekly. The initial course of treatment is 4 weeks.

Subjects who achieve an objective response or stable disease after the initial course (4 weeks) were permitted to continue additional 4-week cycles of treatment, for 3 additional courses starting every 6 months (ie, at 6; 12; and 18 months).
Drug: Rituximab
Rituximab (biosimilar is Zytux) is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B-cells. Rituximab destroys B-cells and is therefore used to treat diseases which are characterized by excessive numbers of B-cells, overactive B-cells, or dysfunctional B-cells. This includes many lymphomas, leukemias, transplant rejection, and autoimmune disorders.
Other Names:
  • Rituxan
  • MabThera
  • IDEC-C2B8
  • Anti-CD20
  • Zytux (biosimilar)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: 5 years
PFS, assessed as the number of patients 5 years after treatment who are alive and without a ≥ 50% increase from nadir in the sum of the product of the greatest lesion diameters (SPD) of any previously-identified abnormal node, or appearance of any new lesion
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: 5 years
OS, assessed as the number of patients 5 years after treatment who are alive
5 years
Overall Response Rate (ORR)
Time Frame: 4 weeks

Overall response as assessed as Complete Response (CR) + Partial Response (PR)

  • CR was determined as complete metabolic response (CMR), meaning complete resolution of 18-fluorodeoxyglucose (FDG) uptake within the tumor volume so that it is indistinguishable from surrounding normal tissue.
  • PR was determined as partial metabolic response (PMR), meaning reduction of greater than 25% in the standardized uptake value (SUV) adjusted for body surface area (SUV-BSA). A reduction in the extent of tumor FDG uptake is not required for PMR.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranjana Advani

Collaborators

Genentech, Inc.

Investigators

  • Study Director: Ranjana H Advani, MD, Stanford University
  • Principal Investigator: Richard T Hoppe, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 1999

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Actual)

April 20, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-13452
  • 75967 (Other Identifier: Stanford IRB, historical)
  • U2082N
  • LYMHD0003 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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