Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma (LIFT)
This study has been terminated.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01275209
First received: January 10, 2011
Last updated: July 30, 2012
Last verified: July 2012
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Purpose
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with bendamustine in patients with follicular lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Follicular Lymphoma |
Drug: HCD122 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Incidence rate of dose-limiting toxicities and adverse events [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 1 |
| Study Start Date: | February 2011 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: HCD122 |
Drug: HCD122
Other Name: Lucatumumab
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275209
Locations
| United States, Massachusetts | |
| Dana Farber Cancer Institute SC-5 | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6) | |
| Detroit, Michigan, United States, 48201 | |
| United States, Tennessee | |
| Sarah Cannon Research Institute SCRI (2) | |
| Chattanooga, Tennessee, United States, 37404 | |
| Belgium | |
| Novartis Investigative Site | |
| Gent, Belgium, 9000 | |
| Novartis Investigative Site | |
| Leuven, Belgium, 3000 | |
| Canada, Ontario | |
| Novartis Investigative Site | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| France | |
| Novartis Investigative Site | |
| Paris, France, 75475 | |
| Italy | |
| Novartis Investigative Site | |
| Pisa, PI, Italy, 56126 | |
| Novartis Investigative Site | |
| Reggio Calabria, RC, Italy, 89124 | |
| Novartis Investigative Site | |
| Torino, TO, Italy, 10126 | |
| Spain | |
| Novartis Investigative Site | |
| Barcelona, Cataluña, Spain, 08035 | |
| Novartis Investigative Site | |
| Madrid, Spain, 28046 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01275209 History of Changes |
| Other Study ID Numbers: | CHCD122A2104, 2010-022350-17 |
| Study First Received: | January 10, 2011 |
| Last Updated: | July 30, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Federal Public Service (FPS) Health, Food Chain Safety and Environment Italy: Italian Pharmaceutical Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Canada: Health Canada Netherlands: Medicines Evaluation Board Spain: Medicines and Health Products Agency (AEMPS) Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Novartis:
|
HCD122 Lucatumumab CD40 |
Follicular Lymphoma Non-Hodgkin's Lymphoma Antibody |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
Bendamustine Rituximab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on October 18, 2012
