|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
11 January 2021 |
|
Main ID: |
NCT01275209 |
|
Date of registration:
|
10/01/2011 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
LIFT |
|
Scientific 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 |
|
Date of first enrolment:
|
February 2011 |
|
Target sample size:
|
1 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01275209 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1
|
|
|
Countries of recruitment
|
|
Australia
|
Belgium
|
Canada
|
France
|
Italy
|
Netherlands
|
Spain
|
United States
|
|
Contacts
|
|
Name:
|
Novartis Pharmaceuticals |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Novartis Pharmaceuticals |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Follicular Lymphoma
|
|
Intervention(s)
|
|
Drug: HCD122
|
|
Primary Outcome(s)
|
|
Incidence rate of dose-limiting toxicities and adverse events
[Time Frame: 2 years]
|
|
Secondary Outcome(s)
|
|
Response rate
[Time Frame: 2 years]
|
|
Secondary ID(s)
|
|
CHCD122A2104
|
|
2010-022350-17
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|