Randomized phase III trial comparing early treatment with fludarabine, cyclophosphamide + rituximab versus deferred treatment in untreated Binet Stage A patients with high risk of progression.

Phase 1

• Conditions: ntreated mail or female patients with newly diagnosed binet stage A CLL, as defined by NCI criteria.; MedDRA version: 9.1Level: LLTClassification code 10008976Term: Chronic lymphocytic leukemia

• Registration Number: EUCTR2005-003018-14-CZ
• Lead Sponsor: Deutsche CLL-Studiengruppe, Klinik fur Innere Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-28
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Established dg of B-CLL by NCI criteria.
2. Binet stage A.
3. First diagnosis within 12 months before inclusion in study.
4.Start of therapy possible within 28 days after completed risk stratification/randomization.
5. No prior chemotherapy, radiation or antibody treatment.
6. Age > 18 years.
7. Life expectancy > 6 months.
8. ECOG performance status 0/2.
9. All parameters for risk stratification present.
10. Willingness to accept contraception if randomiyed to Cohort I for the duration of therapy and 12 months thereafter.
11. Negative serum pregnancy test one week prior to trešatmentr for premenopausal women.
12. Possibility of follow-up.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Age < 18 years.
2. ECOG performance status > 2.
Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive hemolytic anaemia.
4. Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than B-CLL prior to the study.
5. Medical condition requiring prolonged (estimated to be more than one month) use of oral corticosteroids.
6. History of anaphylactic reaction following exposure to humanized monoclonal antibodies.
7. Patients with active bacterial, viral or fungal infection.
8. Known infection with HIV, Hepatitis B or C.
9. Pregnancy and/or nursing.
10. Concurrent severe disease which exclude the administratio of therapy:
- heart insufficiency NYHA grade III/IV; LEVF < 50% and or RF < 30%, MI within the past6 months prior this study
-severe chronic obstructive lung disease with hypoxemia
-severe DM
- hypertension difficult to control
-impaired renal function with creatinine clearence < 70ml/min according to the formula Cockroft-Gault
-serum bilirubin > 2x ULN
-cerebral dysfunction or any other coexisting medical or psychological condition that would preclude participation in the required study procedures
11. Transformation to aggresive B cell malignancy (i.e. diffuse large cell lymphoma, Richter´s syndrome or prolymphocytic leukemia).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified