Rituximab in Treating Patients With Hodgkin's Lymphoma
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| ClinicalTrials.gov Identifier: NCT00003820 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma Hodgkin Lymphoma (Category) Nodular Lymphocyte Predominant Hodgkin Lymphoma | Drug: Rituximab | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 39 participants |
| Allocation: | N/A |
| 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 |
| Study Start Date : | January 1999 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | August 2008 |
| Arm | Intervention/treatment |
|---|---|
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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:
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- 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
- 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.
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| Ages Eligible for Study: | 3 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| United States, California | |
| Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| Study Director: | Ranjana H Advani, MD | Stanford University | |
| Principal Investigator: | Richard T Hoppe, MD | Stanford University |
| Responsible Party: | Ranjana Advani, Saul A. Rosenberg, MD, Professor of Lymphoma, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00003820 |
| Other Study ID Numbers: |
IRB-13452 75967 ( Other Identifier: Stanford IRB, historical ) U2082N LYMHD0003 ( Other Identifier: OnCore ) |
| First Posted: | January 27, 2003 Key Record Dates |
| 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 |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases Rituximab Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |