Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase III Study of Lenalidomide Maintenance After Debulking Therapy in Patients With Advanced Cutaneous T-Cell Lymphoma
Brief Summary: RATIONALE: Observation is watching a patient's condition but not giving treatment unless symptoms appear or change. Lenalidomide may stop the growth of cancer cells by blocking blood flow to the cancer. It is not yet known whether observation or lenalidomide is more effective in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for cutaneous T-cell lymphoma or mycosis fungoides/Sézary syndrome.

PURPOSE: This randomized phase III trial is studying observation to see how well it works compared with lenalidomide in treating patients who are in complete or partial response after receiving previous gemcitabine hydrochloride or doxorubicin hydrochloride liposome for stage IIB, stage III, or stage IV cutaneous T-cell lymphoma or stage IIB, stage III, or stage IV mycosis fungoides/Sézary syndrome.


Options:
A: DISEASE CHARACTERISTICS:

* Diagnoses of advanced T-cell cutaneous lymphoma or mycosis fungoides/Sézary syndrome

  * Stage IIB-IV disease
* Achieved complete or partial response after undergoing prior debulking therapy with 1 of the following recommended\* regimens with or without radiotherapy\*\*:

  * Gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 of a 28-day course at a dose of 1,000 to 1,200 mg/m² for a total of four courses
  * Pegylated liposomal doxorubicin hydrochloride IV over 1 hour on days 1 and 15 of a 28-day course at a dose of 20 mg/m² for a total of four courses NOTE: \*These recommended regimens can be altered according to local institutional policies. In case of drug intolerance, the study regimen can be switched from one regimen to the other.

NOTE: \*\*Local low-dose/energy-ionizing radiation therapy allowed as part of the debulking process to treat lesions that do not respond after 3 courses of debulking chemotherapy.

* Sézary cell burden must be decreased by at least 50% after debulking in patients with Sézary syndrome
* Disease not appropriate for skin-directed therapy per local institution standards
* No disease progression between registration and randomization
* No CNS involvement

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* Life expectancy \> 12 months
* Hemoglobin ≥ 10 g/dL
* Absolute neutrophil count ≥ 1.5 x 10\^9/L
* Platelet count ≥ 60 x 10\^9/L
* Total bilirubin ≤ 1.5 times upper limit of normal (UNL)
* Alkaline phosphatase ≤ 3 times UNL
* ALT/AST ≤ 3 times UNL
* Electrolytes (including sodium, potassium, and chloride) normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* Uric acid and calcium normal
* Free T4 and TSH ≤ 1.5 times ULN
* Patients with a buffer range from the normal values of +/- 10% for hematology and biochemistry are acceptable
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception 4 weeks prior to, during, and for 4 weeks after completion of study therapy
* Males must agree not to donate semen during and for 1 week after completion of study therapy
* Patients with high risk for or history of a thromboembolic event must agree to receive prophylactic anticoagulation therapy (e.g., vitamin K) to keep INR in the range of 2-3
* No New York Heart Association class III-IV disease
* No blood donating during and for 1 week after completion of study therapy
* No uncontrolled infectious disease, autoimmune disease, or immunodeficiency
* No second malignancies within the past 3 years except surgically cured carcinoma in situ of the cervix, in situ breast cancer, incidental finding of stage T1a or T1b prostate cancer, and basal or squamous cell carcinoma of the skin
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* No Lapp lactase deficiency or history of glucose-galactose malabsorption

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No other prior intravenous chemotherapy for this cancer

  * For purposes of this protocol, the definition of intravenous chemotherapy also includes denileukin diftitox, antibodies, or antibody conjugates
* No prior splenectomy or splenic irradiation
* No concurrent topical corticosteroids

  * Concurrent systemic corticosteroids allowed for treatment of tumor flare reactions
* No radiation or drug-based therapy (including steroids) between registration and randomization
* No other concurrent drugs (including steroids) during the debulking regimen

  * Low-dose steroids as premedication allowed at the investigator's discretion
* No other concurrent anticancer treatments
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 IIB, IVA, or IVB
* Refractory or recurrent disease after at least 2 of the following prior therapies:

  * Local and/or systemic steroids
  * Retinoids
  * Interferon alfa
  * Local carmustine
  * Systemic chemotherapy
  * Psoralen and ultraviolet A (PUVA) light therapy
* No CNS involvement
* No erythroderma (T4)

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* Not specified

Hematopoietic

* Neutrophil count at least 1,500/mm\^3
* WBC at least 2,000/mm\^3
* Platelet count at least 75,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic

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

Renal

* Creatinine no greater than 1.5 times ULN

Cardiovascular

* LVEF normal by echocardiography or radionuclide angiocardiography

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 years after study participation
* No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up
* No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy)
* No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics
* More than 2 weeks since prior immunotherapy

Chemotherapy

* See Disease Characteristics
* Prior systemic chemotherapy allowed provided all of the following conditions are met:

  * Cumulative anthracycline dose is less than 200 mg/m\^2
  * No allergy to anthracyclines
  * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg)
* More than 2 weeks since prior chemotherapy

Endocrine therapy

* See Disease Characteristics
* No concurrent systemic steroids

Radiotherapy

* More than 2 weeks since prior radiotherapy

Surgery

* Not specified

Other

* Recovered from toxic effects of prior therapy, excluding alopecia
* No other concurrent anticancer therapy
D: 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.

Answer: A