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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03069248
Other study ID # 089-2000
Secondary ID
Status Completed
Phase Phase 2
First received February 17, 2017
Last updated March 1, 2017
Start date June 1, 2000
Est. completion date September 17, 2009

Study information

Verified date February 2017
Source Sunnybrook Health Sciences Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a non-comparative, prospective, non-randomized single centre phase II clinical trial of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer Centre/Sunnybrook and Women's Health Sciences Centre.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 17, 2009
Est. primary completion date September 17, 2009
Accepts healthy volunteers No
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 of rituximab must exceed 12 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab

Alpha Interferon


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 Survival (Overall survival) Overall survival From date of randomization until date of death or last follow-up, whichever comes first, assessed up to 116 months
Primary Survival (Progression free survival) Progression free survival From date of randomization until date of relapse or disease progression, assessed up to 116 months
Secondary Toxicities (Possible transplant-related adverse events) Possible transplant-related adverse events such as secondary malignancies, hypogammaglobulinemia, and pulmonary fibrosis assessed semi-annually, from date of enrollment up to 116 months
Secondary Minimal Residual Disease Occult disease by PCR analysis of the t(14;18) or of patient specific V(D)J rearrangements in peripheral blood, bone marrow and stem cell graft collections. assessed semi-annually, from date of enrollment up to 116 months
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