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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060384
Recruitment Status : Active, not recruiting
First Posted : February 2, 2010
Last Update Posted : September 5, 2017
Celgene Corporation
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska

Brief 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.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Lenalidomide Drug: ofatumumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Lenalidomide and Ofatumumab for the Treatment of Relapsed or Refractory Non-Hodgkin's Lymphoma
Study Start Date : March 2010
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Arm 1 Drug: Lenalidomide

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

Drug: ofatumumab
8 weekly infusions of ofatumumab 1000mg.

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) [ Time Frame: maximum of 18 patients enrolled ]

Secondary Outcome Measures :
  1. 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 ]
  2. Survival and event free survival [ Time Frame: Every 6 months after last dose of study drug until death ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01060384

United States, Nebraska
Saint Francis Medical Center
Grand Island, Nebraska, United States, 68803
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
Celgene Corporation
Principal Investigator: Julie M Vose University of Nebraska

Responsible Party: Julie M Vose, MD, Professor, University of Nebraska Identifier: NCT01060384     History of Changes
Other Study ID Numbers: 514-09-FB
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents