EUCTR2007-007587-21-CZActive, not recruitingPhase 1
Phase III trial of combined immunochemotherapy with Fludarabine, Cyclophosphamide and Rituximab (FCR) versus Bendamustine and Rituximab (BR) in patients with previously untreated chronic lymphocytic leukemia - CLL10
GCLLSG - Dept. of Internal Medicine I, University Hospital Cologne0 sites550 target enrollmentStarted: August 10, 2010Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 550
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 18 years of age or older.
- •2. Confirmed diagnosis of B-CLL.
- •3. Stage Binet C or stage Binet B and A requiring treatment. Requiring treatment is defined as:
- •a) Binet stage B or Binet A plus at least one of the following 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)
- •- progressive lymphocytosis (lymphocytosis is defined as peripheral lymphocyte count > 5 x 10.9 (increase > 50% over a 2-month period or doubling of peripheral lymphocyte count < 6 months)
- •- 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) or progressive or symptomatic lymphadenopathy
- •b) Binet stage A with severe B-Symptoms (night sweats, weight loss >=10% within the previous 6 months, fevers > 38°C or 100.4°F for ³ 2 weeks without evidence of infection).
- •4. World Health Organization performance status of 0-2.
- •5. Life expectancy> 6 months.
- •6. Adequate liver function as indicated by a total bilirubin, AST, and ALT =2 the institutional ULN value, unless directly attributable to the patient’s tumor.
- •7. Willingness of fertile Male and female patients to use an highlyeffective contraceptive method with a Pearl-Index < 1 (such as implants, injectables, oral contraceptives in combincation with an other contraceptive method, some IUDs, sexual abstinence or vasectomised partner) while on study treatment and for a minimum of six months following study therapy
- •8. Signed, written informed consent.
- •9. Patient is a) male b) female and ³ 2 years after the onset of menopause c) female and < 2 years after the onset of menopause and has a negative serum pregnancy test one week prior treatment.
- •10. Negative serological Hepatitis B test, negative testing of Hepatitis C RNA, negative HIV test within 6 weeks prior to registration.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
- •1. CIRS-Score > 6 or a single score of 4 for one organ category
- •2. Patients with a 17p deletion detected by FISH (these patients will be treated within the CLL2O or CLL2L protocol of the GCLLSG)
- •3. Creatinine clearance <70ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24h-urine collection. Creatinine clearance is to be calculated only in patients with serum creatinine > and = 1,1 mg/dl.
- •4. Any prior chemotherapy and/or radiotherapy and/or immunotherapy, except for prednisolone treatment administered due to very high lymphocyte counts immediately before first FCR or BR treatment.
- •5. Patients who have progressed with more aggressive B-cell cancers such as Richter’s syndrome.
- •6. Active secondary malignancy requiring treatment (except basal cell carcinoma or malignant tumour curatively treated by surgery).
- •7. History of anaphylaxis following exposure to monoclonal antibodies or any of the study drugs.
- •8. Active bacterial, viral or fungal infection.
- •9. Medical condition requiring prolonged use of oral corticosteroids (> 1 month).
- •10. Cerebral dysfunction, legal incapacity.
- •11. Pregnant or nursing women, fertile men or women of childbearing potential not using adequate contraception.
- •12. Any circumstance at the time of study entry that would preclude completion of the study or the required follow-up.
- •13. Participation in any other clinical trial
Investigators
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