Lenalidomide in HTLV-1 Adult T-Cell Leukemia
Condition: Adult T Cell Leukemia/Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell
Intervention: Lenalidomide
Intervention description: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ATLL

Summary:

      This is a research study for subjects who have been diagnosed with Adult T cell
      Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus
      HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this
      research study is to evaluate the use of the investigational drug lenalidomide in the
      treatment of Adult T cell Leukemia/Lymphoma.

      Lenalidomide is a drug that alters the immune system and it may also interfere with the
      development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
      may reduce or prevent the growth of cancer cells.

      Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of
      specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for
      patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM
      are cancers of the blood. It is currently being tested in a variety of cancer conditions. In
      this case it is considered experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years at the time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  Relapsed or refractory HTLV-1 associated Adult T-cell Leukemia/Lymphoma (Acute and
             lymphoma subtypes)

          -  All previous cancer therapy, including radiation, hormonal therapy and surgery, must
             have been discontinued at least 4 weeks prior to treatment in this study.

          -  ECOG performance status of ≤ 2 at study entry (see Appendix C).

          -  Laboratory test results within these ranges:

               -  Absolute neutrophil count ≥ 1000/mm³

               -  Platelet count ≥ 50,000 /mm³

               -  Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault formula
                  (Appendix J). Patients with calculated creatinine clearance ≥ 30 mL/min and < 60
                  mL/min will have a reduced starting dose of lenalidomide (see Section 5.4.2).

               -  Total bilirubin ≤ 1.5 x ULN

               -  AST (SGOT) and ALT (SGPT) ≤ 3 x ULN.

          -  Disease free of prior malignancies for ≥ 5 years with exception of currently treated
             basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix
             or breast.

          -  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
             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. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and
             Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling
             Guidance Document.

          -  Patients at high risk for DVT/PE must be able to take aspirin (81 or 325 mg) daily as
             prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low
             molecular weight heparin).

        Exclusion Criteria:

          -  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.

          -  Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see
             Appendix H). Subjects may be enrolled upon correction of electrolyte abnormalities.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum 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.

          -  Known positive for HIV or infectious hepatitis, type B or C.

          -  Recent DVT/PE requiring dose adjustments of anticoagulation within past 90 days