Status:
UNKNOWN
Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia
Lead Sponsor:
Tawam Hospital
Conditions:
B-Cell Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Fludarabine (F) alone or in combination with cyclophosphamide (FC) is not a curative treatment for patients with CLL, all patients will eventually relapse. Therefore there is a medical need to look fo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00336206
Start Date
July 1 2006
End Date
October 1 2009
Last Update
July 25 2006
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