Lenalidomide and Blinatumomab in treating patients with Non-Hodgkin Lymphoma that has returned

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"Study of Immunotherapy (Lenalidomide and Blinatumomab) looking at side effects and best dose for treatment of lymphoma"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Non-Hodgkin's lymphoma, cancer, lymphoma, immunotherapy
Type:
Biological study, Phase 1
Investigator:
Description
This study looks at 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.
This study requires
Contact for more information
Who can participate?
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 == 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

- 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 (ie. 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) 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

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

- No history of acquired immune deficiency syndrome (AIDS)-defining conditions other than lymphoma or history of CD4+ T-cells below 200/mm^3 prior to beginning combination antiretroviral therapy (cART)

- After HIV diagnosis and during treatment with cART, patients should have maintained CD4+ T-cells >= 350/mm^3 prior to lymphoma diagnosis; patients who never immune reconstituted to a stable level above 350/mm^3 are not eligible

- At time of study entry CD4+ T-cells must have recovered from prior lymphoma therapy to >= 250/mm^3

- At the time of study entry the HIV viral load must be undetectable by standard laboratory assay

- 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


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

- 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
Resources
Schedule
Study duration and period
Contact for more information
Recruitment period
From Aug. 24, 2016
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Sofia Milunovich
Research Topic
Conditions:
  • B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classical Hodgkin Lymphoma
  • CD19 Positive
  • Mediastinal Lymphoma
  • Recurrent Adult Burkitt Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Marginal Zone Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Small Lymphocytic Lymphoma

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