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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma, Follicular
• Intervention / Treatment: Other: Follow up

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre, Odette Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Twelve patients with low grade follicular lymphoma who consented to long term follow-up and were previously treated with high dose therapy and autologous stem cell transplant with rituximab and alpha interferon as part of the phase II 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Other: Follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Neil Berinstein, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2013
• Primary Completion (Actual): March 15, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: February 10, 2017
• First Submitted That Met QC Criteria: March 17, 2017
• First Posted (Actual): March 23, 2017

Study Record Updates

• Last Update Posted (Actual): March 23, 2017
• Last Update Submitted That Met QC Criteria: March 17, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, Follicular
• Other Study ID Numbers: Rituxan INF II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No