Clinical Trial 18930

Cancer Type: Malignant Hematology
Interventions:AMG103 (Blinatumomab); Blinatumomab; CC-5013 (Lenalidomide); Lenalidomide (Revlimid)

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Julio Chavez

Overview

Study Title

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

Summary

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.

Objective

The primary endpoint for this study is toxicity which is coded according to the CTCAE v4. The primary objective is to determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with blinatumomab in the proposed regimen.

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 less than or equal to 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 12 weeks
  • Absolute neutrophil count > 1000/mcL
  • Platelets >= 50,000/mcL
  • Total bilirubin less than or equal to1.5 x institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) less than or equal to 2.5 x institutional upper limit of normal
  • Body surface area (BSA)-normalized creatinine clearance >= 60 mL/min/1.73 m^2 (using Cockcroft-Gault creatinine clearance [CrCl])
  • Must have had at least two prior chemotherapeutic or biologic (i.e., rituximab alone) regimens and not currently eligible for standard curative options; 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) and males must meet all contraception requirements outlined in the study documentation.
  • 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 willingness to sign a written informed consent document
  • Human immunodeficiency virus (HIV) infected patients: To be eligible, all the other eligibility criteria listed above and additional specific criteria outlined in the study documentation must be met.

  • 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
  • Receiving any other investigational agents
  • 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
  • Women who are pregnant; breastfeeding should be discontinued if the mother is treated with lenalidomide
  • Concurrent use of other anti-cancer agents or treatments
  • Known active hepatitis, type B or C; patients on suppressive therapy with a negative viral load and no evidence of hepatic damage are eligible
  • Prior treatment with blinatumomab or CD-directed CAR T-cell therapy
  • Prior treatment with lenalidomide within 8 weeks prior to entering the study