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

NCT02232516 | Active Not Recruiting Phase 2 Results DMC

• 5 other identifiers: NU 14H04NCI-2014-01770RV-CL-PTCL-PI-003974STU00097620P30CA060553
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Peripheral T-cell Lymphoma; Stage I Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IA Mycosis Fungoides/Sezary Syndrome; Stage IB Mycosis Fungoides/Sezary Syndrome; Stage II Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIA Mycosis Fungoides/Sezary Syndrome; Stage IIB Mycosis Fungoides/Sezary Syndrome; Stage III Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IIIA Mycosis Fungoides/Sezary Syndrome; Stage IIIB Mycosis Fungoides/Sezary Syndrome; Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma; Stage IVA Mycosis Fungoides/Sezary Syndrome; Stage IVB Mycosis Fungoides/Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR), as Defined Per Cheson Criteria

  The endpoint for this objective will be objective response rate (ORR), defined per Cheson criteria. Response will be assessed by imaging after cycles 3 and 6, and then every 6 months thereafter. Response at 3 months (after cycle 3) will be used for purposes of the interim efficacy analysis.

  Assessed after cycles 3 and 6, then every 6 months up to 3 years

Secondary Outcomes (5)

• Incidence of Toxicity Assessed Using the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

  Evaluated once per cycle (1 cycle=28 days) up to 1 year.

• Progression-free Survival (PFS)

  Reported at 1 and 3 years after the start of treatment

• Overall Survival (OS)

  Reported at 1 and 2 years after the start of treatment

• Duration of Response, Defined Per Cheson Criteria

  Assessed from start of therapy for up to 3 years

• Delay to Cytotoxic Chemotherapy

  Up to 1 year

Other Outcomes (3)

• NM PET/CT vs. CT Imaging in PTCL

  Up to 3 years

• Validate a New Prognostic Model for Newly Diagnosed PTCL

  Up to 3 years

• Immunohistochemistry Profile

  Baseline

Study Arms (1)

Treatment (romidepsin, lenalidomide)

EXPERIMENTAL

Patients receive romidepsin IV over 4 hours on days 1, 8, and 15 and lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Drug: romidepsin; Drug: lenalidomide; Other: laboratory biomarker analysis

Interventions

romidepsin DRUG

Given IV

Also known as: FK228, FR901228, Istodax

Treatment (romidepsin, lenalidomide)

lenalidomide DRUG

Given PO

Also known as: CC-5013, IMiD-1, Revlimid

Treatment (romidepsin, lenalidomide)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (romidepsin, lenalidomide)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Northwestern University: lead
• Celgene: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Weill Cornell Medicine

New York, New York, 10021, United States

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Ruan J, Zain J, Palmer B, Jovanovic B, Mi X, Swaroop A, Winter JN, Gordon LI, Karmali R, Moreira J, Petrich AM, Pro B. Multicenter phase 2 study of romidepsin plus lenalidomide for previously untreated peripheral T-cell lymphoma. Blood Adv. 2023 Oct 10;7(19):5771-5779. doi: 10.1182/bloodadvances.2023009767.

  PMID: 37327113 DERIVED

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell; Lymphoma, Large-Cell, Anaplastic; Immunoblastic Lymphadenopathy; Lymphoma, T-Cell, Peripheral; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

romidepsin; Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphadenopathy

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Jonathan Moreira
• Organization: Northwestern University, Feinberg School of Medicine

jonathan.moreira@northwestern.edu

312-695-6180

Study Officials

• Jonathan Moreira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 5, 2014
• Study Start: June 11, 2015
• Primary Completion: August 11, 2020
• Study Completion: August 1, 2024
• Last Updated: April 10, 2024
• Results First Posted: April 10, 2024

Record last verified: 2024-03

Locations

US (5)