Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
Brief Summary: T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively uncommon and therefore not well studied. Treatment approaches are patterned after the more common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this study, we will administer the drug called lenalidomide as a pill to patients with T-cell lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to determine if the treatment is well tolerated in this patient group. This study will take place at six cancer centres across Canada.


Options:
A: Inclusion Criteria:

* Male and female subjects ≥ 18 years of age at the time of enrollment, except in Japan where subjects must be ≥ 20 years of age at the time of enrollment
* Histologically confirmed diagnosis of mycosis fungoides (MF) or Sezary Syndrome (SS)
* Stage IB, II-A, II-B, III and IV
* Subjects who had failed at least one prior course of systemic therapy. Psoralen plus ultraviolet light therapy (PUVA) is not considered to be a systemic therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 1 at study entry
* Resolution of all clinically significant toxic effects of prior cancer therapy to grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI-CTCAE, v.4.0)
* Adequate hematological, renal and hepatic function
* Subjects previously treated with anti-CD4 antibody or alemtuzumab were eligible provided their CD4+ cell counts were ≥ 200/mm3
* Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization were eligible provided they continued to receive stable doses of prophylactic antibiotics
* Women of childbearing potential (WOCBP) must have had a negative pregnancy test within 7 days of receiving study medication
* WOCBP and male subjects as well as their female partners of childbearing potential must have agreed to use effective contraception throughout the study and for 3 months after the last dose of KW-0761

Exclusion Criteria:

* Prior treatment with KW-0761 or vorinostat.
* Large cell transformation. However, subjects with a history of LCT but without current aggressive disease and no current evidence of LCT on pathology in skin and lymph nodes would be eligible.
* Diagnosed with a malignancy in the past two years. However, subjects with non-melanoma skin cancers, melanoma in situ, localized cancer of the prostate with current PSA of \<0.1 ng/mL, treated thyroid cancer or cervical carcinoma in situ or ductal/lobular carcinoma in situ of the breast within the past two years could enroll as long as there was no current evidence of disease.
* Clinical evidence of central nervous system (CNS) metastasis.
* Psychiatric illness, disability or social situation that would have compromised the subject's safety or ability to provide consent, or limited compliance with study requirements.
* Significant uncontrolled intercurrent illness
* Known or tested positive for human immunodeficiency virus (HIV), human T-cell leukemia virus (HTLV-1), hepatitis B or hepatitis C.
* Active herpes simplex or herpes zoster. Subjects on prophylaxis for herpes who started taking medication at least 30 days prior to study entry, and had no active signs of active infection, and whose last active infection was more than 6 months ago, could enter the study, and should have continued to take the prescribed medication for the duration of the study.
* Experienced allergic reactions to monoclonal antibodies or other therapeutic proteins.
* Known active autoimmune disease were excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
* Was pregnant (confirmed by beta human chorionic gonadotrophin \[β-HCG\]) or lactating.
* History of allogeneic transplant.
B: Inclusion Criteria:

* T-cell lymphoma (excluding mycosis fungoides)
* WHO performance status 0-2
* measurable lesions
* acceptable hematological and biochemical parameters
* previously treated OR untreated but not suitable for standard therapy

Exclusion Criteria:

* pregnant
* HIV
* viral hepatitis
C: DISEASE CHARACTERISTICS:

* Histologically confirmed mycosis fungoides

  * Stage IB or IIA
  * Confirmed by current or prior diagnostic lesion biopsy

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* WBC at least 2,000/mm\^3
* Hemoglobin at least 9 g/dL

Hepatic

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2.5 times ULN

Renal

* Creatinine no greater than 2 times ULN
* Calcium no greater than 11.5 mg/dL

Cardiovascular

* No New York Heart Association grade III or IV cardiac insufficiency

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 3 months after study participation\* NOTE: \*Women using hormonal contraception must also use a non-hormonal treatment
* Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization)
* Willing and able to avoid prolonged exposure to the sun

  * Willing to limit sun exposure on day of PUVA therapy
* No prior intolerance of or unresponsiveness to PUVA therapy
* No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No prior pancreatitis
* No other concurrent serious illness or infection that would preclude study participation
* No concurrent excessive alcohol consumption
* No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors
* No psychological, familial, sociological, or geographical condition that would preclude study compliance
* No known contraindications to study drug
* No known hypersensitivity to retinoids or hypervitaminosis A
* No uncontrolled diabetes mellitus
* No uncontrolled thyroid disease

PRIOR CONCURRENT THERAPY:

Biologic therapy

* At least 3 months since prior interferon therapy

Chemotherapy

* No prior systemic combination chemotherapy
* No prior participation in another study of bexarotene
* At least 3 months since prior topical chemotherapy

Endocrine therapy

* At least 1 month since prior topical corticosteroids

Radiotherapy

* At least 6 months since prior total skin electron beam therapy
* At least 1 month since prior superficial radiotherapy

Surgery

* Not specified

Other

* At least 30 days since prior participation in another investigational drug study
* At least 3 months since prior photopheresis
* At least 1 month since prior UVB/PUVA phototherapy
* At least 1 month since prior retinoid class drugs
* At least 1 month since prior beta-carotene compounds
* At least 1 month since other prior topical medications (e.g., tar baths)
* No prior participation in this study
* No other concurrent anticancer therapy
* No other concurrent investigational drug therapy
* No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations
D: Inclusion Criteria:

* Histopathologically documented MF clinical stage IA-IIB (see Table1) confirmed by current or previous diagnostic lesion biopsy
* A Karnofsky performance score \> 60
* No previous PUVA treatment
* Anti-ds-DNA (antinuclear antibodies) or anti-Ro/La antibodies: negative
* Acceptable organ function defined as follows:

SGOT (AST) and SGPT (ALT) \< 2.5 times the upper limit of normal for the institution

* Creatinine \< 2 times the upper limit of normal for the institution
* No evidence of severe cardiac insufficiency (NYHA grade III-IV)
* Women of child bearing potential must have a negative serum pregnancy test (ß-HCG) within seven (7) days prior to randomization
* Absence of any serious intercurrent illness or infection at time of entry into the study that could interfere with planned treatment
* Patients must be willing to accept limiting sun exposure on the day receiving PUVA treatment
* Written informed consent

Exclusion Criteria:

* Pregnancy and Lactation
* Photosensitive diseases such as lupus erythematosus or basal cell nevus syndrome
* Skin cancer syndromes such as xeroderma pigmentosum or basal cell nevus syndrome

Answer: B