A phase I study of subcutaneous alemtuzumab in combination with oral fludarabine in previously untreated patients with chronic lymphocytic leukaemia. - FULLSCALE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000741-19-GB

Enrollment

Registered

2006-03-20

Start date

2007-07-04

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukaemia (CLL)

Interventions

Trade Name: MabCampath Product Name: MabCampath Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: alemtuzumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) At least 18 years old. (2) Written informed consent. (3) Previous confirmation of B-CLL with a characteristic immunophenotype on peripheral blood flow cytometry (4) Creatinine and bilirubin or S-GOT/S-GPT 6cm below left costal margin) or progressive splenomegaly - Progressive lymphocytosis with an increase >50% over a 2 month period or an anticipated lymphocyte doubling time of less than 6 months. - Lymphocyte count > 100 x 109/l - B symptoms 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

Exclusion criteria: (1) Any previous therapy for CLL (2) Known HIV, HBV, HCV positive (3) Active infection (4) Past history of anaphylaxis following exposure to rat or mouse derived CDR-grafted humanised monoclonal antibodies (5) Use of prior investigational agents within 6 weeks (6) Pregnancy or lactation (7) CNS involvement with CLL (8) Mantle cell lymphoma (9) Other severe, concurrent diseases or mental disorders (10) Active secondary malignancy or a history of malignancy during previous 5 years except treated cervical carcinoma or skin basalioma

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the response rate with minimal residual disease (MRD) assessment by 4 colour flow cytometry in patients with previously untreated CLL.; Secondary Objective: To assess the safety of combined alemtuzumab and fludarabine in untreated CLL patients. To investigate the pharmacokinetic profile of alemtuzumab in the first line setting when combined with fludarabine. To evaluate immune response to CMV. ; Primary end point(s): The primary endpoint of the study is the determination of the MRD response rate (CR + PR and MRD eradication). The secondary endpoints are to evaluate the safety and toxicity of alemtuzumab and fludarabine in this setting and to evaluate immune response to CMV.	—

Measure

Time frame

Main Objective: To determine the response rate with minimal residual disease (MRD) assessment by 4 colour flow cytometry in patients with previously untreated CLL.; Secondary Objective: To assess the safety of combined alemtuzumab and fludarabine in untreated CLL patients. To investigate the pharmacokinetic profile of alemtuzumab in the first line setting when combined with fludarabine. To evaluate immune response to CMV. ; Primary end point(s): The primary endpoint of the study is the determination of the MRD response rate (CR + PR and MRD eradication). The secondary endpoints are to evaluate the safety and toxicity of alemtuzumab and fludarabine in this setting and to evaluate immune response to CMV.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026