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A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Non-Hodgkin's Lymphoma

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Trial Information

A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma


Inclusion Criteria:



- Patients who have undergone high-dose therapy and autologous PBSCT for treatment of
CD20+ lymphoma.

- Patients must be between 2-6 months post-transplantation at the time of study
registration.

- Patients must have at least stable disease (no overt progressive disease) at the time
of study registration.

- Laboratory values must be within protocol specified ranges.

- Females of childbearing potential must have a negative pregnancy test.

- Females of childbearing potential and males must use an effective method of
contraception from the time of consent until at least 365 days following
discontinuation of protocol therapy.

Exclusion Criteria:

- Patient must not have obvious clinical progression of lymphoma after PBSCT as
determined by the treating physician.

- Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV
antibody.

- No major or uncontrolled comorbid conditions as determined by the treating physician:
history of ventricular arrhythmias requiring drug or device therapy; uncontrolled
angina or symptomatic congestive heart failure; • severe or uncontrolled infection
requiring systemic antibiotic or antifungal therapy or active hepatitis C infection;
severe or uncontrolled psychiatric illness.

- No known leptomeningeal involvement by lymphoma or current metastatic brain disease.

- No Corrected QTc interval > 480 msec.

- No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion
of the investigator is a contraindication to their participation in the study.

- No systemic (oral or parenteral) corticosteroids within 14 days of study entry.

- Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other
investigational therapy.

- No previous treatment with SB-485232 or ofatumumab.

- No history of other malignancy except for adequately treated non-invasive cancers of
the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.

- No diabetes mellitus with poor glycemic control (documented hemoglobin A1c >7% within
4 weeks prior to study entry).

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab

Outcome Description:

Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).

Outcome Time Frame:

8 weeks

Safety Issue:

Yes

Principal Investigator

Michael Robertson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University Melvin and Bren Simon Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

IUCRO-0397

NCT ID:

NCT01768338

Start Date:

February 2013

Completion Date:

Related Keywords:

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

Name

Location

Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289