Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia

• Status: Unknown status
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate if the treatment with Alemtuzumab (after I or II line chemotherapy) administered for 6 weeks followed by 4 months maintenance treatment compared to a control group can reduce disease activity/residual disease and thereby delay the reoccurrence of the CLL disease.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tawam Hospital
• Treatments: Alemtuzumab

Criteria

Inclusion Criteria:

• B-CLL diagnosis taken consideration of NCI criteria.

• In case of CR: positive MRD status

• At least achieving a PR to the last line of antitumor therapy given and than at least PR is still present after a follow-up of 3-6 months after the last antitumor course (wash-out period)

• Age >18 years and < 75 years.

• WHO performance status 0-II.

• ANC ≥1.0 x 109/L

• Platelet count ≥50 x 109/L

• Negative pregnancy test in fertile females

• Anticipated life expectancy ≥ 12 months

• Signed informed consent

• Fertile men or women of childbearing potential using adequate contraception (oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)

Exclusion Criteria:

• Elapsed time of less than 3 months or more than 6 months since last dose of previous antitumor therapy

• Previous Alemtuzumab administration.

• Contraindication for Alemtuzumab

• More than 2 previous treatment regimens

• SD or PD on last antitumor therapy

• Persistent CLL symptoms in clinical need of further antitumor therapy

• History of severe pneumocytis carinii infection (PCP)

• HIV positive

• Active hepatitis or a history of prior viral hepatitis B or hepatitis C, or positive hepatitis B serologies without prior immunization

• Active viral, fungal or bacterial infection.

• Active autoimmune hemolytic anemia or active autoimmune thrombocytopenia.

• Severe concurrent diseases or mental disorders.

• Significant renal dysfunction ( serum creatinine ≥150 µmol/l or creatinine clearance < 30 ml/min)

• Significant hepatic dysfunction (total bilirubin or transaminases >2 times ULN)

• Pregnancy or lactation.

• Active secondary malignancy.

• Participating in other clinical trials.

• Transformation to aggressive B-cell malignancy (e.g., large B-cell lymphoma, Richter's syndrome, or prolymphocytic leukemia (PLL);

• Bulky disease requiring anti-tumor therapy.

• Planned or previous BMT