Rituximab in Treating Patients With Hodgkin's Lymphoma

NCT00003820 | Completed Phase 2 Results FDA Drug

• 4 other identifiers: IRB-1345275967U2082NLYMHD0003
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  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 Outcomes (2)

• Overall Survival (OS)

  5 years

• Overall Response Rate (ORR)

  4 weeks

Study Arms (1)

Rituximab 375 mg/m2 per week

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).

Drug: Rituximab

Interventions

Rituximab 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.

Also known as: Rituxan, MabThera, Anti-CD20, IDEC-C2B8, Zytux (biosimilar)

Rituximab 375 mg/m2 per week

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ranjana Advani: lead
• Genentech, Inc.: collaborator

Study Sites (2)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (2)

• 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.

  PMID: 24516013 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Rituximab; Biosimilar Pharmaceuticals

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Ranjana Advani, MD, Professor of Lymphoma
• Organization: Stanford University

radvani@stanford.edu

650-725-6456

Study Officials

• Ranjana H Advani, MD

  Stanford University

  STUDY DIRECTOR

• Richard T Hoppe, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Saul A. Rosenberg, MD, Professor of Lymphoma

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: January 1, 1999
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: April 20, 2017
• Results First Posted: April 20, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)