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

Lymphoma, Follicular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087929
• Other study ID #: Rituxan INF II
• Status: Completed
• Phase: N/A
• First received: February 10, 2017
• Last updated: March 17, 2017
• Start date: September 20, 2013
• Est. completion date: March 15, 2017

Study information

• Verified date: March 2017
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma, Follicular

Intervention

Other:
• Follow up

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre, Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Number of months from date of enrollment to date of death or last follow-up, whichever comes first.	through study completion, up to 15 years
Primary	Progression-free survival	Number of months from date of enrollment to date of progression. Progression is defined as a greater than or equal to 50% increase in the sum of the product of measurable lesions. Appearance of new lesions will also constitute progressive disease.	through study completion, up to 15 years
Primary	Event-free survival	Number of months from date of enrollment to date of an event. An event is defined as death, disease progression, transformation, or development of secondary malignancy.	through study completion, up to 15 years
Secondary	Adverse events possibly or probably related to transplant	Adverse events include second malignancies, myelodysplastic syndrome (MDS), hypogammaglobulinemia, and pulmonary fibrosis. This outcome measurement is descriptive.	through study completion, up to 15 years
Secondary	Minimal Residual Disease	This exploratory endpoint is used to evaluate the detection of recurrent lymphoma in peripheral blood DNA. It is measured as real-time quantitative polymerase chain reaction (RQ-PCR) and is expressed as a percent of detection per 100,000 cells at each follow-up time point.	through study completion, up to 15 years