Follicular Lymphoma Clinical Trial
Official title:
Phase II Clinical Trial of Immunotherapy With Rituximab and Autologous Effector Lymphocytes in Patients With Non-Hodgkin Follicular Lymphoma in Response to First Line Chemotherapy
Verified date | October 2017 |
Source | Clinica Universidad de Navarra, Universidad de Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nowadays, therapy with monoclonal antibodies is considered to be a standard treatment that
increases the rate of remissions and the overall survival in patients with follicular
lymphoma. Nevertheless there are an important number of patients who do not benefit from this
therapy. A way to improve the efficiency of monoclonal antibodies therapy could be to improve
the activity of the effector arm of the immune system. A strategy that has been proposed to
obtain this improvement is the utilization of lymphocyte activated killer (LAK) cells. In
addition, the combination of LAK cells with monoclonal antibodies might obtain an additive
effect across the stimulation of the antibody dependent cellular cytotoxicity (ADCC)activity.
The present clinical assay proposes to study the feasibility, safety and effectiveness of
treatment with autologous effector cells expanded ex vivo associated with a standard
maintenance treatment with rituximab in patients with follicular lymphoma in remission after
first-line treatment. In addition, we plan to analyse various biological parameters that can
predict the susceptibility of patients to treatment with rituximab. Specifically, we propose
to study the polymorphisms of Fc receptor, polymorphisms related to the ability of complement
activation, to study both the complement activity and peripheral blood cell subpopulations
that can mediate directly or indirectly dependent antibody cytotoxic effect. We will also try
to correlate any of these biological parameters with the response to treatment.
Status | Active, not recruiting |
Enrollment | 38 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients with histologically-confirmed follicular lymphoma CD20-positive grade 1, 2 ó 3a. - Patients with aptitude to sign the written informed consent and to express his desire to fulfill all the requirements of the protocol during the period of study. - Patients not treated before. The induction treatment with rituximab and chemotherapy must be the first line for the patients who are included in the study. - Patients undergoing maintenance therapy with rituximab every two/three months. - Ann Arbor stage II, III o IV before receiving the induction treatment with rituximab and chemotherapy. - The patient must have achieved a partial or complete response based on the revised International Workshop Response Criteria (IWRC) (Cheson, et al 2007) following the induction treatment. - Age >18 years and <75 years. - Performance status <2 following the Eastern Cooperative Oncology Group (ECOG). - Screening laboratory values obtained 28 days before registry (unless due to lymphoma involvement of the bone marrow): Hemoglobin > 8,0 g/dL (5,0 mmol/L), Neutrophil absolute count > 1,5 x 109/L,Platelets > 100 x 109/L Exclusion Criteria: - Patients with transformed follicular lymphoma into diffuse large B-cell lymphoma. - Patients with evidence of follicular lymphoma grade 3b. - Patients with evidence of primary cutaneous or gastrointestinal follicular lymphoma. - Patients with evidence of current central nervous system involvement. - Patients who received previous induction treatment other than rituximab and chemotherapy. - Patients receiving chronic immunosuppressive agents in the last 4 weeks. Patients may be receiving stable chronic doses of corticosteroids with a maximum dose of 20 mg/day of prednisone or equivalent. - Patients who have a history of another primary malignancy < 3 years, with the exception of non-melanoma skin cancer and carcinoma in situ of the uterine cervix. - Decompensated renal function: serum creatininea > 2,0 mg/dL (197 u.mol/L. - Decompensated hepatic function: total bilirrubine > 2,0 mg/dL (34 umol/L), AST (SGOT) > 3 x ULN, unless due to lymphoma involvement - Patients with a known history of human immunodeficiency virus (HIV) seropositivity, chronic hepatitis or other active viral infections due to hepatitis B virus (HBV) or hepatitis C virus (HVC). - Patients with underlying serious diseases that in the criteria of the investigator could concern the capacity of the patient to take part in the test (for example, infection in process, not controlled diabetes mellitus, gastric ulcers, autoimmune active disease). - Life expectancy <6 months. - Female patients who are pregnant or breast feeding. - Patients with known hypersensitivity to rituximab or other murine proteins or to any of the excipients. - Patients who are using other investigational agents or who have received investigational drus 30 days prior to study drug start. - Any other medical or psychological coexistent condition that rejects the participation in the study or compromises the aptitude to give the informed consent. |
Country | Name | City | State |
---|---|---|---|
Spain | Carlos Panizo | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra | Spanish National Health System |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression free survival (PFS) from the entry in the study. | The PFS is defined as the time from the entry in the study up to the progression of the disease. | 01/03/2015 | |
Secondary | Event free survival from the entry in the study | Event: progression, relapse, death for any reason, or institution of a new anti-lymphoma treatment (chemotherapy, radiotherapy or immunotherapy). | 01/03/2015 | |
Secondary | Time to the next anti-lymphoma treatment | Defined as the time from the registry of the patient up to the institution of a new regimen (chemotherapy, radiotherapy or immunotherapy). | 01/03/2015 | |
Secondary | Disease free survival | Defined as the time from the first complete response documented up to the relapse | 01/03/2015 | |
Secondary | Safety | Defined as the incidence of toxicity of all the treatments. | 01/01/2012 |
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