Completed

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

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What is being tested

Rituximab

Drug
Who is being recruted

Hemic and Lymphatic Diseases+6

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 3 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1999
See protocol details

Summary

Principal SponsorRanjana Advani
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003820
Principal SponsorRanjana Advani
Last updated: April 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

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

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeHodgkin DiseaseLymphoma

Criteria

14 inclusion criteria required to participate
Absolute neutrophil count (ANC) > 1500/mL
Age >= 3 years
Alkaline phosphatase < 2 x ULN, unless related to primary disease
Aspartate transaminase (AST) and alanine transaminase (ALT) < 2 x ULN, unless related to primary disease
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11 exclusion criteria prevent from participating
Active HBV infection or hepatitis
Any other conditions which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Stanford University Medical Center

Stanford, United StatesOpen Stanford University Medical Center in Google Maps

Stanford University School of Medicine

Stanford, United States
Completed2 Study Centers