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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00336206
• Date of registration: 12/06/2006
• Primary sponsor: Tawam Hospital
• Public title: Low Dose Alemtuzumab for Consolidation and Maintenance of Patients With B-Cell Chronic Lymphocytic Leukemia
• Scientific title: Subcutaneous Injection, Low Dose Alemtuzumab for Consolidation and Maintenance of Patients in Clinical Response After Having Achieved Partial or Complete Remission After 1st or 2nd Line Anti-Tumor Therapy for B-Cell CLL
• Date of first enrolment: July 2006
• Target sample size: 60
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT00336206
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Contacts

• Name: Jorgen Kristensen, MD PhD

• Name: Jorgen Kristensen, MD PhD
• Affiliation: Department of Oncology

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

B-Cell Chronic Lymphocytic Leukemia

Intervention(s)

Drug: Alemtuzumab

Primary Outcome(s)

To determine the Time to Treatment Failure (TTF)

Secondary Outcome(s)

Minimal Residual Disease (MRD) evaluated with flow-cytometry (“MRD flow panel”) in patients with CR

To determine Overall Response Rate (ORR).

To evaluate Complete Remission (CR) rate.

To evaluate duration of response.

To evaluate Partial Response (PR) rate.

To evaluate safety

Secondary ID(s)

39338

Source(s) of Monetary Support

Please refer to primary and secondary sponsors