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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Celgene Corporation
GlaxoSmithKline
Information provided by (Responsible Party):
Julie M Vose, MD, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01060384
First received: January 25, 2010
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Non-Hodgkin's Lymphoma
Drug: Lenalidomide
Drug: ofatumumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

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: 40
Study Start Date: March 2010
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060384

Locations
United States, Nebraska
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
Sponsors and Collaborators
University of Nebraska
Celgene Corporation
GlaxoSmithKline
Investigators
Principal Investigator: Julie M Vose University of Nebraska
  More Information

No publications provided

Responsible Party: Julie M Vose, MD, Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01060384     History of Changes
Other Study ID Numbers: 514-09-FB
Study First Received: January 25, 2010
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014