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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01275209




Registration number
NCT01275209
Ethics application status
Date submitted
10/01/2011
Date registered
12/01/2011
Date last updated
5/12/2012

Titles & IDs
Public title
Study of HCD122 (Lucatumumab) and Bendamustine Combination Therapy in CD40+ Rituximab-refractory Follicular Lymphoma
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
Secondary ID [1] 0 0
2010-022350-17
Secondary ID [2] 0 0
CHCD122A2104
Universal Trial Number (UTN)
Trial acronym
LIFT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HCD122

Experimental: HCD122 -


Treatment: Drugs: HCD122


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence rate of dose-limiting toxicities and adverse events
Timepoint [1] 0 0
2 years
Secondary outcome [1] 0 0
Response rate
Timepoint [1] 0 0
2 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
Belgium
State/province [5] 0 0
Gent
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
France
State/province [8] 0 0
Paris
Country [9] 0 0
Italy
State/province [9] 0 0
TO
Country [10] 0 0
Spain
State/province [10] 0 0
Cataluña
Country [11] 0 0
Spain
State/province [11] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the safety and efficacy of HCD122 (Lucatumumab) when combined with
bendamustine in patients with follicular lymphoma.
Trial website
https://clinicaltrials.gov/show/NCT01275209
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications