Clinical trial NCT00003820: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma
Hodgkin Lymphoma (Category)
Nodular Lymphocyte Predominant Hodgkin Lymphoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2003-01-27
Enrollment: 39
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: 5 years
measure: Overall Response Rate (ORR)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Ranjana H Advani, MD
role: STUDY_DIRECTOR
affiliation: Stanford University
name: Richard T Hoppe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.