Know Cancer

or
forgot password

A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin's

Thank you

Trial Information

A Phase I, Open Label Study to Evaluate the Mechanism of Action of Galiximab in Subjects With Previously Untreated Follicular Non-Hodgkin's Lymphoma


Inclusion Criteria:



- Written informed consent (signed and dated).

- Age equal or greater than 18 at the time of consent.

- Histologically confirmed follicular NHL according to the Revised European American
Lymphoma (REAL)/ World Health Organization (WHO) classification (from initial
diagnosis) Grades 1,2, or 3a.

- At least 2 malignant lymph nodes of similar size (>1 cm in minimal dimension) and
location that are readily accessible for excisional biopsy at the time of study
entry.

- Consent to 1 pretreatment and 1 post-treatment excisional biopsy of accessible tumor.

- Acceptable hematologic, hepatic, and renal function parameters.

- WHO Performance Status equal or less than 2.

- Subjects of reproductive potential must agree to follow accepted birth control
methods.

Exclusion Criteria:

- Presence of lymphoma in CNS.

- Previous systemic anticancer treatment for NHL (including but not limited to
radiation, myeloablative, or investigational therapy).

- Concurrent treatment with systemic steroids within 14 days of Day 1.

- Evidence of transformed lymphoma.

- Presence of malignancies within 3 years of Study Day 1 (except for adequately treated
carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of breast, or basal
or squamous cell skin cancer).

- History of HIV infection or AIDS.

- Serious nonmalignant disease.

- Pregnant.

- Inability to comply with study and follow-up procedures.

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding that contraindicates the use of an investigational drug.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Mechanism of action of galiximab given as a single agent in previously untreated subjects with follicular NHL.

Outcome Time Frame:

24 months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

114-NH-103

NCT ID:

NCT00651443

Start Date:

August 2008

Completion Date:

December 2010

Related Keywords:

  • Lymphoma, Non-Hodgkin's
  • galiximab
  • Untreated NHL
  • antibody
  • open-label
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Research SiteAlbany, New York