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Recombinant Human IL-18 and Ofatumumab After PBSCT for Lymphoma

M

Michael John Robertson

Status and phase

Completed
Phase 1

Conditions

Non-Hodgkin's Lymphoma

Treatments

Drug: Ofatumumab combined with SB-485232

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01768338
1210009882 (Other Identifier)
IUCRO-0397

Details and patient eligibility

About

The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Ofatumumab combined with SB-485232
Experimental group
Description:
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
Treatment:
Drug: Ofatumumab combined with SB-485232

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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