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

NCT01060384 | Completed Phase 1 Results DMC

• 1 other identifier: 0514-09-FB
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• Phase I: Maximum Tolerated Dose (MTD) of Lenalidomide

  The maximum tolerated dose (MTD) will be defined as the next lowest dose cohort below where ≥ 2/3 or ≥ 3/6 patients experience dose limiting toxicities in cycle 1.

  7 months

Secondary Outcomes (1)

• Phase I and Phase II: Event Free Survival and Overall Survival

  2 years from start of treatment

Study Arms (1)

Phase 1/Phase II

EXPERIMENTAL

All participants will receive the same dose of Ofatumumab. There will be three planned dose cohorts for the Lenalidomide in the Phase 1 portion of this trial. A maximum of 18 patients will be enrolled in to Phase 1. Three evaluable patients will be enrolled in to each of the dose cohorts with an additional 3 patients to be enrolled in the maximum tolerated dose (MTD). An additional 29 evaluable patients will be enrolled in to Phase II using the MTD for Lenalidomide that was determined in Phase 1.

Drug: Lenalidomide; Drug: ofatumumab

Interventions

Lenalidomide DRUG

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

Also known as: REVLIMID

Phase 1/Phase II

ofatumumab DRUG

8 weekly infusions of ofatumumab 1000mg.

Also known as: Kesimpta

Phase 1/Phase II

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nebraska: lead
• Celgene Corporation: collaborator
• GlaxoSmithKline: collaborator

Study Sites (2)

Saint Francis Medical Center

Grand Island, Nebraska, 68803, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Lenalidomide; ofatumumab

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Julie M. Vose
• Organization: University of Nebraska Medical Center

jmvose@unmc.edu

402-559-3848

Study Officials

• Julie M Vose

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2010
• First Posted: February 2, 2010
• Study Start: March 29, 2010
• Primary Completion: October 25, 2016
• Study Completion: January 1, 2018
• Last Updated: October 4, 2023
• Results First Posted: August 8, 2018

Record last verified: 2023-09

Locations

US (2)