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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Follicular Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence rate of dose-limiting toxicities and adverse events

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CHCD122A2104

NCT ID:

NCT01275209

Start Date:

February 2011

Completion Date:

May 2012

Related Keywords:

  • Follicular Lymphoma
  • HCD122
  • Lucatumumab
  • CD40
  • Follicular Lymphoma
  • Non-Hodgkin's Lymphoma
  • Antibody
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (6)Detroit, Michigan  48201
Dana Farber Cancer Institute SC-5Boston, Massachusetts  02115
Duke University Medical Center Duke Hem & OncDurham, North Carolina  27710
Sarah Cannon Research Institute SC - 2Chattanooga, Tennessee  37404