Phase 2
N=64
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma
Follicular Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00366275 ↗Enrolled (actual)
64
Serious AEs
3.1%
Results posted
Oct 2010
Primary outcome: Primary: Progression-free Survival — 59 percent chance of PFS at 5 years
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Immunochemotherapy, in vivo purging and autrotransplant (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Primary completion
- Jan 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
59 | — |
Summary
The purpose of this study is to determine the rate and duration of complete remission and molecular response in patients with relapsed/refractory follicular lymphoma, using a combined treatment with rituximab plus chemotherapy followed by in vivo purged peripheral blood stem cells (PBSC) mobilization and autotransplant.
Eligibility Criteria
Inclusion Criteria
- Patients with relapsed or refractory follicular lymphoma after chemotherapy
- Patients with relapsed or refractory follicular lymphoma after rituximab as single agent or with chemotherapy
- Patients with transformed follicular lymphoma
- CD20-positivity
- Age between 18 and 60 years
- Advanced Ann Arbor stage
- Normal cardiac, renal and hepatic functions
- Negativity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Total amount of anthracycline previously received 2 mg/dl
- Alanine transaminase (ALT) and alkaline phosphatase > 2N
- Cardiac or pulmonary disease
- Severe organic or psychiatric disease
- Positivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Pregnancy, breastfeeding
- Cancer diagnosis in the 5 years before lymphoma diagnosis, except of non-melanoma skin cancer and Cervical Intraepithelial Neoplasia (CIN)
Data sourced from ClinicalTrials.gov (NCT00366275). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.