Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Lenalidomide and Blinatumomab in Treating Patients with Relapsed Non-Hodgkin Lymphoma

Protocol: OSU-16172

Full Title

A Phase I Trial of the Combination of Lenalidomide and Blinatumomab in Patients with Relapsed or Refractory Non-Hodgkins Lymphoma (NHL)

Purpose

This phase I trial studies the side effects and best dose of lenalidomide and blinatumomab when given together in treating patients with non-Hodgkin lymphoma that has returned after a period of improvement. Biological therapies, such as lenalidomide and blinatumomab, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing.

Study Objective

PRIMARY OBJECTIVES:

I. To determine a recommended phase II dose (RP2D) for blinatumomab in combination with lenalidomide.

SECONDARY OBJECTIVES:

I. To observe and record anti-tumor activity anti-tumor response (complete response [CR] and partial response [PR] as per International workshop lymphoma response criteria).

II. To investigate the immune response to blinatumomab alone and in combination with lenalidomide. Measured by the frequency of activated T-cells, absolute lymphocyte count, antibody dependent cell-mediated cytotoxicity (ADCC), and frequency of B-cells and correlate this with response and toxicity.

OUTLINE: This is a dose-escalation study.

INDUCTION: Patients receive blinatumomab intravenously (IV) continuously on days 1-56 and lenalidomide orally (PO) on days 31-52 in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients achieving response receive blinatumomab IV continuously on days 1-7 and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 2 years.

Are you eligible?

Inclusion Criteria:

Histologically or cytologically confirmed relapsed cluster of differentiation (CD)19+ non-Hodgkin lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, gray zone, primary mediastinal, Burkitt's, diffuse large B cell, small lymphocytic lymphoma)

Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

Life expectancy of greater than 12 weeks

Absolute neutrophil count > 1000/mcL

Platelets >= 50,000/mcL

Total bilirubin =< 2.5 × institutional upper limit of normal

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

Creatinine 2.5 × institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

Patients must have had at least one prior chemotherapeutic or biologic (ie. rituximab alone) regimen; steroids alone and local radiation do not count as regimens

Any prior therapy must have been completed at least 4 weeks prior to entry into the study

Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting lenalidomide 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; men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy; all patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure

Patients must have radiographically measurable disease defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral computed tomography (CT) scan; lesions in previously irradiated anatomic areas (external beam radiation) cannot be considered target lesions unless there has been documented growth of those lesions after radiotherapy

Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier

Patients who are receiving any other investigational agents

Patients with known brain metastases should be excluded from this clinical trial

History of allergic reactions attributed to compounds of similar chemical or biologic composition to lenalidomide and blinatumomab or other agents used in study

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with lenalidomide

Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible

Concurrent use of other anti-cancer agents or treatments

Known active hepatitis, type A, B or C

Hodgkin’s Lymphoma Non-Hodgkin’s Lymphoma (B- & T-Cell) Lymphoma