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Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Leukemia

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Trial Information

Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free Survival (PFS)

Outcome Description:

Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.

Outcome Time Frame:

Median observation time at time of analysis was approximately 21 months

Safety Issue:

No

Principal Investigator

Michael Hallek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Medizinische Universitaetsklinik I at the University of Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

CDR0000454560

NCT ID:

NCT00281918

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Leukemia
  • B-cell chronic lymphocytic leukemia
  • stage I chronic lymphocytic leukemia
  • stage II chronic lymphocytic leukemia
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, B-Cell
  • Leukemia, Lymphoid

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