Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas

NCT00704691 | Terminated Early Phase 1 DMC

• 2 other identifiers: F071108004UAB 0663
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

• assess the effectiveness of lenalidomide for the treatment of patients with relapsed and or refractory peripheral T-cell lymphomas; and,
• assess the safety of lenalidomide. There are reports suggesting a therapeutic benefit of thalidomide in patients with refractory and/or relapsed Non-Hodgkin's Lymphoma's (NHL) which have led to the formal investigation of lenalidomide in the treatment of relapsed NHL's.

Conditions

Peripheral T-cell Lymphomas; Adult T-cell Leukemia; Adult T-cell Lymphoma; Peripheral T-cell Lymphoma Unspecified; Angioimmunoblastic T-cell Lymphoma; Anaplastic Large Cell Lymphoma; T/Null Cell Systemic Type; Cutaneous t-Cell Lymphoma With Nodal/Visceral Disease

Outcome Measures

Primary Outcomes (1)

• Response Rate to lenalidomide (CR,PR and unconfirmed complete responses

  Efficacy assessments every 8 weeks with a final assessment performed at the end of Cycle 6 (wk 24).

Secondary Outcomes (1)

• Toxicity of lenalidomide

  Progressive disease during cycle 1

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Lenalidomide 25 mg as a daily oral dose days 1-21 followed by a 7 day rest period (28 day cycle) for 1-6 cycles

Lenalidomide

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand and voluntarily sign an informed consent form.
• Age 19 and over at the time of signing the informed consent form.
• Able to adhere to the study visit schedule and other protocol requirements.
• Patients with a confirmed diagnosis of peripheral T-cell lymphomas according to the World Health Organization (WHO) classification in the relapsed and/or refractory setting following prior anthracycline therapy. Subtypes of peripheral T-cell lymphomas which meet this criteria will include the following: adult T-cell leukemia/lymphoma, peripheral T-cell lymphoma unspecified, angioimmunoblastic T-cell lymphoma, anaplastic large-cell lymphoma, T/null cell, primary systemic type, subcutaneous panniculitis-like T-cell lymphoma, hepatosplenic gamma-delta T-cell lymphoma, and enteropathy-type T-cell lymphoma \[33\].
• Patients with a history of PTCL or cutaneous T-cell lymphoma (CTCL) with nodal/visceral disease in the relapsed and/or refractory setting following prior anthracycline therapy. This includes ≥ 3-6 cycles of CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) or an equivalent, CHOP-like regimen +/- radiation therapy. The definition for relapsed and refractory disease is provided in Appendix 5.
• All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study.
• At least one measurable lesion according to the International Working Group response criteria for non-Hodgkin's lymphoma (see Appendix 5).
• ECOG performance status of less than or equal to 2 at study entry (see Appendix 2).
• Laboratory test results within these ranges:
• Absolute neutrophil count greater than or equal to 1.5 x 109/L
• Platelet count greater than or equal to 100 x 109/L (\>70 x 10\^9/L if bone marrow was involved)
• Serum creatinine less than or equal to 2.0 mg/dL
• Total bilirubin less than or equal to 1.5 mg/dL
• AST (SGOT) and ALT (SGPT) less than or equal to 2 x upper limit of normal (ULN) or less than or equal to 5 x ULN if hepatic metastases are present.
• Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to therapy and again within 24 hours of prescribing 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. See Appendix 1: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

You may not qualify if:

• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
• Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide).
• Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
• Use of any other experimental drug or therapy within 28 days of baseline.
• Known hypersensitivity to thalidomide.
• The development of erythema nodorum if characterized by a desquamating rash while taking thalidomide or similar drugs.
• Any prior use of lenalidomide.
• Concurrent use of other anti-cancer agents or treatments within the past 28 days.
• Known positive for HIV or infectious hepatitis, type A, B or C.
• (Other) Precursor T-cell lymphomas (including immature T-cell lymphomas/leukemias) and cutaneous T-cell lymphomas (CTCL) with skin as the only organ of involvement
• Patients with prolonged QT interval on baseline EKG (\>430 ms)
• Equal to greater than grade 3 peripheral neuropathy.
• Natural Killer (NK) cell lymphomas

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294 - 0104, United States

Location

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Leukemia-Lymphoma, Adult T-Cell; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, T-Cell; Immunoblastic Lymphadenopathy; Lymphoma, Large-Cell, Anaplastic

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, T-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma; 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

Study Officials

• James Foran, M.D.

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2008
• First Posted: June 25, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 20, 2012

Record last verified: 2012-04

Locations

US (1)