Follicular Lymphoma Clinical Trial
— LIFTOfficial title:
A Phase Ib, Multicenter, Open-label Study of HCD122 Administered Intravenously in Combination With Bendamustine in Patients With CD40+ Follicular Lymphoma Who Are Refractory to Rituximab
| Verified date | December 2012 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Confirmed diagnosis of follicular lymphoma, according to the Revised European American Lymphoma/World Health Organization [REAL/WHO] classification - Documented CD40+ follicular lymphoma - Measurable lesion - Refractory to rituximab - Prior treatment with at least 1 chemotherapeutic regimen - 18 years or older - WHO Performance Status grade 0, 1, or 2 - Life expectancy > 3 months - Obtained written informed consent Exclusion Criteria: - Grade 3b follicular lymphoma or evidence that the indolent lymphoma has transformed to aggressive lymphoma (i.e. DLBCL) - History of another primary malignancy that is currently clinically significant or currently requires active intervention - Prior allogeneic stem cell transplantation - Prior anaphylactic or other severe infusion reaction such that the patient is unable to tolerate human immunoglobulin or monoclonal antibody administration - Impaired cardiac function or clinically significant cardiac disease - History of acute or chronic pancreatitis, surgery of the pancreas, or any risk factors that may increase the risk of pancreatitis - History of an active infection (viral, bacterial, or fungal) requiring systemic therapy within 28 days before study treatment. - Known diagnosis of human immunodeficiency virus (HIV) infection - Evidence of previous hepatitis viral infection such as hepatitis B or hepatitis C - Ongoing corticosteroid use (>10 mg/day prednisone or equivalent) - Pregnant or nursing (lactating) women Other protocol-defined inclusion/exclusion criteria may apply |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Novartis Investigative Site | Prahran | Victoria |
| Belgium | Novartis Investigative Site | Gent | |
| Belgium | Novartis Investigative Site | Leuven | |
| Canada | Novartis Investigative Site | Toronto | Ontario |
| France | Novartis Investigative Site | Paris | |
| Italy | Novartis Investigative Site | Torino | TO |
| Spain | Novartis Investigative Site | Barcelona | Cataluña |
| Spain | Novartis Investigative Site | Madrid | |
| United States | Dana Farber Cancer Institute SC-5 | Boston | Massachusetts |
| United States | Sarah Cannon Research Institute SC - 2 | Chattanooga | Tennessee |
| United States | Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) | Detroit | Michigan |
| United States | Duke University Medical Center Duke Hem & Onc | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Australia, Belgium, Canada, France, Italy, Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence rate of dose-limiting toxicities and adverse events | 2 years | ||
| Secondary | Response rate | 2 years |
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