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A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Non-Hodgkin's Lymphoma

Thank you

Trial Information

A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma


Inclusion Criteria:



- Histologically confirmed follicular lymphoma that has relapsed or has failed primary
therapy

- Progressive disease requiring further treatment

- Bidimensionally measurable disease

- Acceptable hematologic status

- Prestudy WHO performance status of 0, 1, or 2

- Expected survival of >/= 3 months

- Patients with reproductive potential must follow accepted birth control methods
during treatment and for 3 months after completion of treatment

- Female patients must not be pregnant or lactating

- Recovered fully from any significant toxicity associated with prior surgery,
radiation treatments, chemotherapy, biological therapy, ABMT, or investigational
drugs

Exclusion Criteria:

- Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first
scheduled treatment (6 weeks if nitrosourea or mitomycin-C)

- Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled
treatment

- Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months
prior to first scheduled treatment

- Previous exposure to IDEC-114 or any anti-CD80 antibody

- ABMT within 6 months prior to first scheduled treatment

- Abnormal liver function

- Abnormal renal function

- Presence of chronic lymphocytic leukemia (CLL)

- Presence of CNS lymphoma

- Presence of HIV infection or AIDS

- Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma

- Another primary malignancy (other than squamous cell and basal cell carcinoma of the
skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA)
for which the patient has not been disease-free for at least 3 years

- Serious nonmalignant disease which would compromise protocol objectives in the
opinion of the investigator and/or the sponsor

- New York Heart Association Class III or IV cardiac disease or myocardial infarction
within 6 months prior to first scheduled treatment

- Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled
treatment

- Pleural invasion and/or effusion with positive cytology for lymphoma

- Peritoneal invasion and/or ascites with positive cytology for lymphoma

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To characterize the safety profile of IDEC-114 and to define their duration and reversibility

Outcome Time Frame:

March 2010

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

114-20

NCT ID:

NCT00575068

Start Date:

January 2002

Completion Date:

November 2010

Related Keywords:

  • Non-Hodgkin's Lymphoma
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin

Name

Location

Research SiteMesa, Arizona  
Research SiteAlexandria, Minnesota  
Research SiteAlbany, New York  
Research SiteAsheville, North Carolina