Clinical trial NCT03087929: Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
Official title: Phase II Follow-up Trial of Rituximab Interferon Transplant Trial: Study Drug-Rituximab and Alpha Interferon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphoma, Follicular
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-03-23
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, up to 15 years
measure: Progression-free survival
timeFrame: through study completion, up to 15 years
measure: Event-free survival
timeFrame: through study completion, up to 15 years
Secondary outcomes:
measure: Adverse events possibly or probably related to transplant
timeFrame: through study completion, up to 15 years
measure: Minimal Residual Disease
timeFrame: through study completion, up to 15 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre, Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Neil Berinstein, MD
role: PRINCIPAL_INVESTIGATOR
References: