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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Refractory Grade 1 Follicular Lymphoma
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Refractory Marginal Zone Lymphoma
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Recurrent Grade 2 Follicular Lymphoma
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Recurrent Non-Hodgkin Lymphoma
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Recurrent Marginal Zone Lymphoma
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Refractory Diffuse Large B-Cell Lymphoma
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Refractory Follicular Lymphoma
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Refractory Grade 3a Follicular Lymphoma
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Refractory Small Lymphocytic Lymphoma
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Refractory Non-Hodgkin Lymphoma
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Refractory Mantle Cell Lymphoma
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Recurrent Burkitt Lymphoma
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Recurrent Diffuse Large B-Cell Lymphoma
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Recurrent Grade 3 Follicular Lymphoma
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Recurrent Mantle Cell Lymphoma
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Refractory Burkitt Lymphoma
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Refractory Grade 2 Follicular Lymphoma
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Refractory Gray-Zone Lymphoma
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Recurrent Grade 1 Follicular Lymphoma
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Recurrent Grade 3a Follicular Lymphoma
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Recurrent Grade 3b Follicular Lymphoma
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Recurrent Small Lymphocytic Lymphoma
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Recurrent Gray-Zone Lymphoma
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Recurrent Mediastinal Lymphoma
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Refractory Mediastinal Lymphoma
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Refractory Grade 3 Follicular Lymphoma
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