Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon

NCT ID: NCT03087929

Last Updated: 2017-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 12 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-09-20
• Study Completion Date: 2017-03-15

Brief Summary

A previous phase II trial entitled Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon was conducted at the Odette Cancer Centre between 2005 and 2012. The primary objectives of this previous trial was to assess progression free survival and overall survival. Of the 36 patients in this trial, approximately 18 remain in remission. In this new follow up trial, follow up data will prospectively be collected on patients who provide informed consent to do so.

Conditions

Lymphoma, Follicular

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Treatment Arm

Patients who had previously undergone high dose therapy with stem cell support followed by consolidation with Rituximab and alpha-interferon as part of the trial Treatment of Follicular non-Hodgkin's Lymphoma with High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy with Rituximab and Alpha Interferon. The patients in this arm have consented to long-term follow up.

Follow up

Intervention Type: OTHER

Interventions

Follow up

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
• Central pathology review before registration
• Ann Arbor stage III or IV
• Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
• ECOG performance status of <2.
• Patients may have received not more than 1 prior course (4 infusions) of rituximab. Timing from last dose of rituximab must exceed 6 months prior to registration. Patients must have demonstrated at least a PR to rituximab if previously administered.
• Patient consent according to institutional and university human experimentation committee requirements
• Adequate Renal, hepatic and hematopoietic function test unless the abnormal values are thought to be due to involvement with lymphoma as defined by:

• Hb> 85
• ANC >1000/mm3
• Platelets >100,000/mm3
• Serum/Total Bilirubin >=2 SI units
• AST/ALT <2x Upper Limit of Normal

Exclusion Criteria

• Positive serology for HIV
• Uncontrolled Infection
• Pregnancy
• CNS Metastases
• History of Psychiatric Disorder
• Other Malignancy (except nonmelanoma skin cancer)
• Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
• Major surgery, other than diagnostic surgery, within four weeks.
• Presence of anti-murine antibody (HAMA) reactivity. These laboratory results must be available prior to receiving treatment for those patients
• who have received prior murine proteins or patients who have allergies to murine proteins.
• New York Heart Association Class III or IV heart disease (see Appendix H, Clinical Evaluation of Functional Capacity of Patients with Heart Disease in Relation to Ordinary Physical Activity) or myocardial infarction within the past six months.
• Treatment with an investigational drug within 30 days or five half-lives (of the study drug with the longest half-life) prior to entry into the study, which ever is longer.
• Previous chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the last 5 years.
• History of allergic reactions to compounds chemically related to Rituximab.
• Refusal to practice contraception if of reproductive potential.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Neil Berinstein

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neil Berinstein, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

Rituxan INF II

Identifier Type: -

Identifier Source: org_study_id