Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Brief Summary: RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.

PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.


Options:
A: DISEASE CHARACTERISTICS:

* Confirmed diagnosis of B-cell chronic lymphocytic leukemia

  * Rai stage 0-II (Binet stage A) disease
* Meets 1 of the following criteria:

  * High-risk disease, as defined by the following:

    * Serum thymidine kinase level \> 7.0 U/L
    * Elevated β2-microglobulin level
    * Presence of non-nodular bone marrow infiltration
    * Short lymphocyte doubling time
  * Low-risk disease

    * Meets none of the criteria (as listed above) for high-risk disease

PATIENT CHARACTERISTICS:

Performance status

* Not specified

Life expectancy

* More than 6 months

Hematopoietic

* No autoimmune hemolytic anemia
* No thrombocytopenia

Hepatic

* Not specified

Renal

* Not specified

Other

* No severe organ dysfunction
* No other prior or concurrent malignancy

PRIOR CONCURRENT THERAPY:

Chemotherapy

* No prior chemotherapy
* No other concurrent chemotherapy
B: Inclusion Criteria:

* Surgical and procedural patients who require anesthesia services

Exclusion Criteria:

* Patients under the age of 18 years
C: DISEASE CHARACTERISTICS:

* Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria
* Meets 1 of the following criteria:

  * Binet stage C disease
  * Binet stage B disease AND ≥ 1 of the following signs or symptoms\*:

    * B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers \> 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
    * Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count \> 50 G/I)
    * Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
    * Massive, progressive or painful splenomegaly or hypersplenism
    * Massive lymph nodes or lymph node clusters (\> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
    * Occurrence of symptomatic hyperviscosity problems at leukocyte counts \> 200 G/I (symptomatic leukostasis) NOTE: \* Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
* No Binet stage A disease
* No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)

PATIENT CHARACTERISTICS:

* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Cumulative Illness Rating Scale (CIRS) score \> 6
* Life expectancy \> 6 months
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Alkaline phosphatase and transaminases ≤ 2 times ULN
* Creatinine clearance ≥ 70 mL/min
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 months after study treatment
* No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
* No cerebral dysfunction that precludes chemotherapy
* No active bacterial, viral, or fungal infection
* No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
* No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
* No medical or psychological condition that would preclude study therapy
* No concurrent disease that requires prolonged (\> 1 month) therapy involving glucocorticoids

PRIOR CONCURRENT THERAPY:

* No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy
D: Inclusion criteria

* Patients received a perioperative hs-cTnT screening for PMI
* Patient consent available Exclusion criteria
* Patient's refusal

Answer: A