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

NCT03087929 | Completed

• 1 other identifier: Rituxan INF II
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Adverse events possibly or probably related to transplant

  through study completion, up to 15 years

• Minimal Residual Disease

  through study completion, up to 15 years

Study Arms (1)

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

Interventions

Follow up OTHER

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Neil Berinstein, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 23, 2017
• Study Start: September 20, 2013
• Primary Completion: March 15, 2017
• Study Completion: March 15, 2017
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)