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Rituximab in Treating Patients With Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003820
First Posted: January 27, 2003
Last Update Posted: April 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Ranjana Advani, Stanford University
  Purpose
Phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant Hodgkin's lymphoma.

Condition Intervention Phase
Lymphoma Hodgkin Lymphoma (Category) Nodular Lymphocyte Predominant Hodgkin Lymphoma Drug: Rituximab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease

Resource links provided by NLM:


Further study details as provided by Ranjana Advani, Stanford University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: 5 years ]
    OS, assessed as the number of patients 5 years after treatment who are alive

  • 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.


Enrollment: 39
Study Start Date: January 1999
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • Anti-CD20
  • IDEC-C2B8
  • Zytux (biosimilar)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003820


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Ranjana Advani
Genentech, Inc.
Investigators
Study Director: Ranjana H Advani, MD Stanford University
Principal Investigator: Richard T Hoppe, MD Stanford University
  More Information

Publications:
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.

Responsible Party: Ranjana Advani, Saul A. Rosenberg, MD, Professor of Lymphoma, Stanford University
ClinicalTrials.gov Identifier: NCT00003820     History of Changes
Other Study ID Numbers: IRB-13452
75967 ( Other Identifier: Stanford IRB, historical )
U2082N
LYMHD0003 ( Other Identifier: OnCore )
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: May 29, 2013
Results First Posted: April 20, 2017
Last Update Posted: April 20, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents