Rituxan INF II

Titre officiel

Phase II Follow-up trial for Rituximab Interferon Transplant trial: Study Drug-Rituximab, Interferon

Sommaire:

Un essai antérieur de phase II intitulé « Traitement à forte dose d’un lymphome de bas grade en association avec une greffe de cellules souches, suivi d’une immunothérapie de consolidation par le rituximab et l’interféron alpha » a été mené à l’OCC (Odette Cancer Centre) entre 2005 et 2012. Cet essai visait principalement à évaluer la survie sans progression et la survie globale. Sur les 36 patients ayant participé à cet essai, environ 18 sont toujours en rémission. Dans ce nouvel essai de suivi, des données de suivi seront recueillies de façon prospective auprès des patients ayant donné leur consentement éclairé à cette collecte.

Description de l'essai

The objectives of this trial are to:

• Obtain long-term clinical follow-up on patients treated in the Phase II trial- Treatment of low grade lymphoma with high dose therapy and stem cell support followed by consolidative immunotherapy with Rituximab and interferon α conducted at the Odette Cancer Centre between 2005 and 2012.
• Obtain long term follow-up on adverse events possibly related to the study treatment. Specifically, second malignancies, myelodysplastic syndrome (MDS), hypogammaglobulinemia, and pulmonary fibrosis.
• Obtain long-term follow-up on exploratory endpoints such as molecular remissions and immune competence.

We propose to prospectively collect follow-up clinical, molecular and adverse event data on these patients.  Patients will be entered into the study after signing informed consent.  

Patients will be followed every 6 months.  At each follow-up appointment, clinical information will be collected including survival and relapse.  If relapse has occurred the nature of the next treatment will be documented. Occurrence of a possible adverse event will be documented.  Routine blood work to evaluate major organ function (renal and hepatic), thyroid function (TSH), quantitative immunoglobulins will be obtained.  We will also obtain blood work twice annually for quantitation of B and T cells and molecular remission status by real- time polymerase chain reaction (PCR).  At baseline, we will test for immune competence to common recall antigens.  Abdomen/pelvis ultrasound will be performed annually.  CT scans and BM aspirate and biopsy will be obtained only if clinically indicated. If such tissue is obtained, the specimen will also be tested by PCR for detection of the original lymphoma.  Patients will be followed until time of next treatment for relapse or death (which ever comes first).

Data will be collected on case report forms specifically designed for this study and data will be entered into a database which will correlate this follow-up information on other demographic data already collected.

Patients will be free to withdraw from this study at their own discretion at any time point.