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

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Brief Title

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

Official Title

Open-Label, One Arm Pilot Investigation of Lenalidomide Therapy for Patients With Relapsed and/or Refractory, Peripheral T-Cell Lymphomas

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.
    

Detailed Description

      Peripheral T-cell lymphomas (PTCL's) represent a subgroup of Non-Hodgkin's lymphomas with
      poor prognostic features. Compared to aggressive B-cell lymphomas, PTCL's often present with
      more advanced disease and sustain less durable remissions following treatment with
      chemotherapy. With standard anthracycline-based regimens such as CHOP (cyclophosphamide,
      doxorubicin, vincristine, prednisone), PTCLs achieve inferior 5-year overall survival rates
      of around 40% compared to aggressive B-cell lymphomas whose 5-year overall survival rates
      reach 50-60%. While several salvage regimens have been established for B-cell lymphomas with
      moderate success, the guidelines for patients with relapsed and/or refractory PTCL's are less
      clear. Several reports suggest that the immunomodulatory drugs (IMiDs®) have clinical
      activity in this setting. The aim of this phase 2 study is to evaluate the activity of
      lenalidomide in relapsed and/or refractory PTCL's.
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Toxicity of lenalidomide

Condition

Peripheral T-cell Lymphomas

Intervention

Lenalidomide

Study Arms / Comparison Groups

 Lenalidomide
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

1

Start Date

June 2008

Completion Date

December 2009

Primary Completion Date

July 2009

Eligibility Criteria

        Inclusion Criteria:

          1. Understand and voluntarily sign an informed consent form.

          2. Age 19 and over at the time of signing the informed consent form.

          3. Able to adhere to the study visit schedule and other protocol requirements.

          4. 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].

          5. 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.

          6. All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

          7. At least one measurable lesion according to the International Working Group response
             criteria for non-Hodgkin's lymphoma (see Appendix 5).

          8. ECOG performance status of less than or equal to 2 at study entry (see Appendix 2).

          9. 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.

         10. 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.

             * For patients who have latex allergies or whose partner(s) have latex allergies
             alternatives will be discussed.

         11. All study participants must be registered into the mandatory RevAssist® program, and
             be willing and able to comply with the requirements of RevAssist®.

         12. Disease free of prior malignancies for greater than or equal to 5 years with exception
             of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma
             "insitu" of the cervix or breast

         13. Able to take aspirin (81 mg) daily as prophylactic anticoagulation, if deemed
             necessary by investigator (patients intolerant to ASA may use warfarin or low
             molecular weight heparin).

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          2. Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          3. 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.

          4. Use of any other experimental drug or therapy within 28 days of baseline.

          5. Known hypersensitivity to thalidomide.

          6. The development of erythema nodorum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          7. Any prior use of lenalidomide.

          8. Concurrent use of other anti-cancer agents or treatments within the past 28 days.

          9. Known positive for HIV or infectious hepatitis, type A, B or C.

         10. (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

         11. Patients with prolonged QT interval on baseline EKG (>430 ms)

         12. Equal to greater than grade 3 peripheral neuropathy.

         13. Natural Killer (NK) cell lymphomas
      

Gender

All

Ages

19 Years - N/A

Accepts Healthy Volunteers

No

Contacts

James Foran, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00704691

Organization ID

F071108004

Secondary IDs

UAB 0663

Responsible Party

Sponsor

Study Sponsor

University of Alabama at Birmingham


Study Sponsor

James Foran, M.D., Principal Investigator, University of Alabama at Birmingham


Verification Date

April 2012