Non Hodgkin Lymphoma Clinical Trial

Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma

Summary

The purpose of this study is to evaluate how safe and effective the combination of the study drugs romidepsin and lenalidomide is for treating patients with peripheral t-cell lymphoma (PTCL) who have not been previously treated for this cancer. Currently, there is no standard treatment for patients with PTCL; the most common treatment used is a combination of drugs called CHOP, but this can be a difficult treatment to tolerate because of side effects, and is not particularly effective for most patients with PTCL. Romidepsin (Istodax®) is a type of drug called an HDAC inhibitor. It interacts with DNA (genetic material in cells) in ways that can stop tumors from growing. It is given as an infusion through the veins. Lenalidomide (Revlimid®) is a type of drug known as an immunomodulatory drug, or IMID for short. This drug affects how tumor cells grow and survive, including affecting blood vessel growth in tumors. It is given as an oral tablet (by mouth).

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Full Description

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of the combination of romidepsin plus lenalidomide in patients with previously untreated peripheral T-cell lymphoma (PTCL).

SECONDARY OBJECTIVES:

I. Evaluate the safety of the combination of romidepsin and lenalidomide. II. Further evaluate efficacy of the combination of romidepsin and lenalidomide.

III. Evaluate the delay to cytotoxic chemotherapy.

TERTIARY OBJECTIVES:

I. Evaluate the use of Northwestern Medicine (NM) positron emission tomography (PET)/computed tomography (CT) vs CT imaging in PTCL.

II. Validate a new prognostic model for newly diagnosed PTCL. III. Investigate the tumor immunohistochemical profile to identify potential biomarkers associated with prognosis and treatment response.

OUTLINE:

Patients receive romidepsin intravenously (IV) over 4 hours on days 1, 8, and 15 and lenalidomide orally (PO) once daily (QD) on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression, inter-current illness that prevents further administration of treatment, unacceptable toxicity, patient decides to withdraw from study treatment (or study as a whole), or general or specific changes in the patient's condition render the patient unacceptable for further treatment in the judgment of the treating investigator.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 3 years.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed diagnosis of PTCL (using the most recent edition of the World Health Organization [WHO] Classification of Tumors of Hematopoietic and Lymphoid Tissues as guidance) including:

Anaplastic large cell lymphoma, anaplastic large cell kinase (ALK)-negative
Angioimmunoblastic T-cell lymphoma
Enteropathy-type T-cell lymphoma
Extranodal natural killer (NK)/T-cell lymphoma, nasal type
Hepatosplenic gamma-delta T-cell lymphoma
Peripheral T-cell lymphoma, unspecified (not otherwise specified [NOS])
Transformed mycosis fungoides
Subcutaneous panniculitis-like T-cell lymphoma.
NOTE: Patients with adequate archived (well-preserved, formalin-fixed) biopsy tissue remaining will be required to submit a portion for exploratory studies; this is not optional if tissue is available; however, lack of adequate tissue for exploratory studies will not preclude patients from participating

Patients must have bi-dimensionally measurable disease (>= 1 cm) by CT imaging

NOTE: Patients with marrow-only disease are eligible; response for these patients will be assessed by repeat bone marrow biopsy

Patients must fit into one of the following categories:

Age >= 18 years to < 60 years with a cumulative illness rating scale (CIRS) score >= 6 OR deemed ineligible for cytotoxic chemotherapy by the treating investigator
>= 60 years

Patients must have adequate organ and marrow function (documented within 14 days prior to registration) as outlined below:

Absolute neutrophil count (ANC) >= 750/mcl
Hemoglobin >= 8 g/dl
Platelets >= 50,000/mcl
Total bilirubin =< 2 x upper limit normal (ULN)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum pyruvate glutamate transaminase [SPGT]) =< 3 x ULN
Creatinine =< 2 x ULN
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 2

All patients must agree to use effective contraception while on study, and all patients must agree to undergo counseling sessions every 28 days about pregnancy precautions and risks of fetal exposure

Females of childbearing potential (FCBP) 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 starting lenalidomide, during lenalidomide therapy, during dose interruptions, and for at least 28 days following discontinuation of lenalidomide therapy
Males receiving lenalidomide must agree to use a latex condom during any sexual contact with FCBPs even if they have undergone a successful vasectomy

NOTE: A FCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

Has not undergone a hysterectomy or bilateral oophorectomy
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
FCBP should be referred to a qualified provider of contraceptive methods, if needed

FCPB must have a negative urine or serum pregnancy test within 7 days prior to registration, and be willing to adhere to the scheduled pregnancy testing as required in the Revlimid Risk Evaluation and Mitigation Strategies (REMS®) program

NOTE: Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately

Patients must be free of any prior malignancies for >= 1 year

NOTE: The exception to this would be currently treated squamous cell and basal cell carcinoma of the skin, carcinoma in situ of the cervix, breast, or bladder, or surgically removed melanoma in situ of the skin (stage 0) with histologically confirmed free margins of excision
All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program
Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration

Exclusion Criteria:

Patients with a diagnosis of any of the following are not eligible:

Anaplastic large cell lymphoma, ALK-positive
Adult T-cell lymphoma/leukemia (ATLL)
Anaplastic large-cell lymphoma, primary cutaneous type
Precursor T-lymphoblastic lymphoma/leukemia
Mycosis fungoides/Sezary syndrome (except transformed Mycosis fungoides [MF])
NK-cell leukemia
T-cell granular lymphocytic leukemia
T-cell prolymphocytic leukemia
Patients must not have received prior systemic therapy for PTCL (except for corticosteroids for 10 or fewer days at any dose, no washout period required as long as they discontinue prior to starting study therapy); NOTE: topical treatment may have been given for prior existence of cutaneous lymphoma that has since become systemic PTCL; however, these topical therapies should be stopped at time of registration
Patients who received chemotherapy (including monoclonal antibodies) or radiotherapy, administered for any condition, within 4 weeks prior to registration are not eligible
Patients who received prior exposure to any other histone deacetylase (HDAC) inhibitors or immunomodulatory (IMID) agents for any reason are not eligible
Patients receiving ongoing treatment with any other investigational agents are not eligible
Patients who have known central nervous system (CNS) involvement of lymphoma are not eligible

Patients who have an uncontrolled intercurrent illness including, but not limited to, any of the following are not eligible:

Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
Psychiatric illness/social situations that would limit compliance with study requirements
Patients with a known human immunodeficiency (HIV) infection are not eligible
Patients who are pregnant or actively nursing an infant are not eligible
Patients with a QT interval > 500 msec (using the Bazett's formula) within 28 days prior to registration are not eligible

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT02232516

Recruitment Status:

Active, not recruiting

Sponsor:

Northwestern University

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There are 5 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Yale University
New Haven Connecticut, 06520, United States
Northwestern University
Chicago Illinois, 60611, United States
Weill Cornell Medicine
New York New York, 10021, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Estimated Enrollment:

30

Study ID:

NCT02232516

Recruitment Status:

Active, not recruiting

Sponsor:


Northwestern University

How clear is this clinincal trial information?

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