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Rituximab in Treating Patients With Hodgkin's Lymphoma

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Ranjana Advani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center
  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab 375 mg/m2 per week

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival (OS)
OS, assessed as the number of patients 5 years after treatment who are alive
Overall Response Rate (ORR)
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.

Full Information

First Posted
November 1, 1999
Last Updated
March 8, 2017
Sponsor
Ranjana Advani
Collaborators
Genentech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00003820
Brief Title
Rituximab in Treating Patients With Hodgkin's Lymphoma
Official Title
Phase 2 Trial to Evaluate the Efficacy of Anti-CD20 Antibody in Patients With Lymphocyte Predominant Hodgkin's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 1999 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ranjana Advani
Collaborators
Genentech, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Hodgkin Lymphoma (Category), Nodular Lymphocyte Predominant Hodgkin Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab 375 mg/m2 per week
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera, Anti-CD20, IDEC-C2B8, Zytux (biosimilar)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS, assessed as the number of patients 5 years after treatment who are alive
Time Frame
5 years
Title
Overall Response Rate (ORR)
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ranjana H Advani, MD
Organizational Affiliation
Stanford University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Richard T Hoppe, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24516013
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

Learn more about this trial

Rituximab in Treating Patients With Hodgkin's Lymphoma

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