Rituximab in Treating Patients With Hodgkin's Lymphoma

NCT ID: NCT00003820

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-01-31
• Study Completion Date: 2008-08-31

Brief Summary

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

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.

Conditions

Lymphoma; Hodgkin Lymphoma (Category); Nodular Lymphocyte Predominant Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Rituximab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Rituxan; MabThera; Anti-CD20; IDEC-C2B8; Zytux (biosimilar)

Eligibility Criteria

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Ranjana Advani

OTHER

Sponsor Role: lead

Responsible Party

Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ranjana H Advani, MD

Role: STUDY_DIRECTOR

Stanford University

Richard T Hoppe, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

References

Advani RH, Horning SJ, Hoppe RT, Daadi S, Allen J, Natkunam Y, Bartlett NL. Mature results of a phase II study of rituximab therapy for nodular lymphocyte-predominant Hodgkin lymphoma. J Clin Oncol. 2014 Mar 20;32(9):912-8. doi: 10.1200/JCO.2013.53.2069. Epub 2014 Feb 10.

Reference Type: RESULT

PMID: 24516013 (View on PubMed)

Horning SJ, Bartlett NL, Breslin S, et al. Results of a prospective phase II trial of limited and extended rituximab treatment in nodular lymphocyte predominant Hodgkin's disease (NLPHD). Blood [ASH Annual Meeting Abstracts]. 2007;110:abs644.

Reference Type: RESULT

Other Identifiers

75967

Identifier Type: OTHER

Identifier Source: secondary_id

U2082N

Identifier Type: -

Identifier Source: secondary_id

LYMHD0003

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-13452

Identifier Type: -

Identifier Source: org_study_id