Overview

Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this trial is to investigate the efficacy (how well the drug works) of ofatumumab and lenalidomide in patients with lymphoma and to investigate if any possible unwanted side effects may occur. The purpose of the Phase I portion of this trial will be to determine the maximum dose of these medications that can be given with minimal side effects.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Nebraska
Collaborators:
Celgene Corporation
GlaxoSmithKline
Treatments:
Antibodies, Monoclonal
Lenalidomide
Ofatumumab
Thalidomide
Criteria
Inclusion Criteria:

- Histologically confirmed diagnosis of CD20+ non-Hodgkin's lymphoma that is recurrent
or refractory after at least one prior therapy and for which no other potentially
curative therapy is available.

- Subject, age > or = 19 years

- Patients must have relapsed or refractory disease after at least one prior systemic
therapy, with at least a 3 week interval from the completion of the most recent
chemotherapy or radiotherapy regimen (unless the patient has had progressive disease
prior to the 3 weeks). Patient has resolved all toxicities to ≤ grade 1, felt to be
related to prior therapy.

- Patients must be ineligible or relapsed after an autologous or allogeneic stem cell
transplant if clinically appropriate.

- Adequate Laboratory Parameters:

- ANC ≥ 1500/μL

- Platelet count ≥75,000/μL

- Total bilirubin ≤ 1.5 times the institutional Upper Limit of Normal (ULN)- unless
due to NHL

- Hepatic enzymes (AST, ALT ) ≤ 2.5 times the institutional ULN - unless due to NHL

- Serum Creatinine < 3.0 times the institutional ULN - unless due to NHL

- Creatinine clearance ≥60ml/min during phase I (See Appendix A) Creatinine
clearance ≥ 30ml/min during phase II and patients with creatinine clearance ≥
30ml/min and < 60ml/min should start Lenalidomide at a reduced dose. See Section
5.3.1

- Females of child-bearing potential (FCBP) must agree to:

Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test
with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24
hours prior to prescribing lenalidomide (prescriptions must be filled within 7 days) and
must either commit to continued abstinence from heterosexual intercourse or begin TWO
acceptable methods of birth control, one highly effective method and one additional
effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide.
FCBP must also agree to ongoing pregnancy testing. See Appendix B: Risks of Fetal Exposure,
Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Note: A FCBP is a sexually mature woman who: 1) has not undergone a hysterectomy or
bilateral oophorectomy or 2) has not been naturally postmenopausal (i.e., amenorrhea
following cancer therapy does not rule out childbearing potential) for at least 24
consecutive months (i.e., has had menses at any time in the preceding 24 consecutive
months).

Male patients must:

- Agree to use a condom during sexual contact with a FCBP, even if they have had a
vasectomy, throughout study drug therapy, during any dose interruption and 28 days
after cessation of study therapy.

- Agree to not donate semen during study drug therapy and for a period after end of
study drug therapy

- ECOG Performance status of 0-2 (See Appendix C)

- Signed written informed consent including HIPAA according to institutional guidelines

Exclusion Criteria:

- No malignancy [other than the one treated in this study] which required systemic
treatment within the past 3 years.

- Patients not willing to take DVT prophylaxis

- Pregnant or lactating females

- Positive serology for hepatitis B (HB) defined as positive test of HBsAg. In addition,
if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test
will be performed and if positive the subject will be excluded. Patients with
documented vaccination against Hepatitis B will not be considered positive.

- Known seropositive for active viral infection with human immunodeficiency virus (HIV),
or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus
vaccine are eligible.

- Patients with ≥ Grade 2 neuropathy

- Active hepatic or biliary disease (with exception of patients with Gilbert's syndrome,
asymptomatic gallstones, liver metastases or stable chronic liver disease per
investigator assessment)

- Known CNS involvement with lymphoma

- Significant concurrent, uncontrolled medical condition, that in the judgment of the
investigator, may affect the patient's ability to sign the informed consent and comply
with study procedures.