Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska
First received: January 25, 2010
Last updated: April 26, 2013
Last verified: April 2013
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase I/II Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Primary Outcome Measures:
- Maximum Tolerated Dose (MTD) [ Time Frame: maximum of 18 patients enrolled ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- determine the safety of Lenalidomide and Ofatumumab in relapsed or refractory NHL [ Time Frame: after each dose of study drugs and 30 days after stopping study drugs ] [ Designated as safety issue: Yes ]
- Survival and event free survival [ Time Frame: Every 6 months after last dose of study drug until death ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||January 2015 (Final data collection date for primary outcome measure)
Dose Cohort -1^ 10mg daily on Days 1-21 every 28 days
Dose Cohort +1^^ 15mg daily on Days 1-21, every 28 days
Dose Cohort +2 20 mg daily on Days 1-21, every 28 days
Dose Cohort #3 25 mg daily on Days 1-21, every 28 days
^Used only if Dose Cohort +1 requires further reduction
^^Starting Dose Cohort in Phase I
8 weekly infusions of ofatumumab 1000mg.
|Ages Eligible for Study:
||19 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060384
|Saint Francis Medical Center
|Grand Island, Nebraska, United States, 68803 |
|Great Plains Regional Medical Center
|North Platte, Nebraska, United States, 69101 |
|University of Nebraska Medical Center
|Omaha, Nebraska, United States, 68198 |
University of Nebraska
||Julie M Vose
||University of Nebraska
No publications provided
||Julie M Vose, MD, Professor, University of Nebraska
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 25, 2010
||April 26, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Neoplasms by Histologic Type
Immune System Diseases
Physiological Effects of Drugs
Angiogenesis Modulating Agents