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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follow up | Other |
|
| 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 |
| 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 |
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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:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Neil Berinstein, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre, Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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 |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |