Non Hodgkin Lymphoma Clinical Trial

Lenalidomide and Blinatumomab for the Treatment of Relapsed Non-Hodgkin Lymphoma

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 (relapsed). Biological therapies, such as lenalidomide, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread.

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Full Description

PRIMARY OBJECTIVE:

I. To determine the maximum tolerated dose (MTD) of lenalidomide when given in combination with blinatumomab in the proposed regimen.

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.

III. To document the infection rate with a 96-hour bag change schedule for blinatumomab.

OUTLINE: This is a dose-escalation study of lenalidomide.

INDUCTION: Patients receive blinatumomab intravenously (IV) continuously on days 1-56 and lenalidomide orally (PO) on days 29-49 in the absence of disease progression or unacceptable toxicity.

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

MAINTENANCE: Patients receiving response including stable disease after completion of Consolidation receive lenalidomide PO on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

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

View Eligibility Criteria

Eligibility Criteria

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); patients previously treated with CD19-targeted therapy (including chimeric antigen receptor T-cells [CAR T]) must have a subsequent biopsy and/or flow cytometry confirming CD19 positivity
Karnofsky >= 60%
Life expectancy of greater than 12 weeks
Absolute neutrophil count > 1000/mcL
Platelets >= 50,000/mcL
Total bilirubin =< 1.5 x 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
AST (SGOT)/ALT(SGPT) (only if elevated liver function tests [LFTs] are due to disease) =< 5.0 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])
Patients must have had at least two prior chemotherapeutic or biologic (e.g. rituximab alone) regimens and not currently eligible for standard curative options; steroids alone and local radiation do not count as regimens; radiation to > 1 site and transplant are considered prior 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; radiographically measurable disease is 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

Human immunodeficiency virus (HIV) infected patients are eligible provided they meet all the other eligibility criteria of the study in addition to the following:

During prior lymphoma therapy, patients must not have experienced documented infections attributed to the HIV+ status
No history of non-adherence to cART and willing to adhere to cART while on study

Antiretroviral drugs with overlapping or similar toxicity profiles as study agents not allowed:

Efavirenz not allowed due to potential central nervous system (CNS) toxicity
Stavudine not allowed due to potential neuropathic effects
Zidovudine not allowed due to myelosuppressive effects
Patients must be willing to be followed at a minimum of approximately every 3 months by physician expert in HIV disease management
Patients must be willing to be followed at a minimum of approximately every 3 months by physician expert in HIV disease management

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 because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
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 because lenalidomide is an agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lenalidomide, 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 lenalidomide within 8 weeks prior to entering the study

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

44

Study ID:

NCT02568553

Recruitment Status:

Active, not recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 21 Locations for this study

See Locations Near You

University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
UC San Diego Moores Cancer Center
La Jolla California, 92093, United States
Los Angeles General Medical Center
Los Angeles California, 90033, United States
USC / Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Keck Medical Center of USC Pasadena
Pasadena California, 91105, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Smilow Cancer Center/Yale-New Haven Hospital
New Haven Connecticut, 06510, United States
Yale University
New Haven Connecticut, 06520, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Northside Hospital
Atlanta Georgia, 30342, United States
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States
Vanderbilt University/Ingram Cancer Center
Nashville Tennessee, 37232, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

44

Study ID:

NCT02568553

Recruitment Status:

Active, not recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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