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Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) - A Phase I/II Trial With Concomitant Evaluation of Safety and Efficacy

Phase 1/Phase 2
18 Years
Open (Enrolling)
Leukemia, Lymphocytic, Chronic, B-Cell

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Trial Information

Bendamustine Combined With Alemtuzumab in Pretreated Chronic Lymphocytic Leukemia (CLL) - A Phase I/II Trial With Concomitant Evaluation of Safety and Efficacy

This is a non-randomized, multicenter, open-label, single-arm Phase I/II study to evaluate
the safety and efficacy of bendamustine combined with alemtuzumab in patients with
pretreated CD20-positive CLL (according to the revised NCI/ IWCLL criteria).

Eligible patients will receive bendamustine as 4 courses of 70 mg/m2 on days 1 and 2 every
28 days and 30 mg alemtuzumab s.c. continuously on days 1, 3 and 5 of every week, for a
maximum of 16 weeks. Safety assessments will be conducted weekly; efficacy assessments
including imaging will be performed at months 2, 4, 6, 10 and 16. Bone marrow biopsies will
be performed upon CR (according to the 2008 IWCLL response criteria) or fixed at 6 and 16

Following recruitment of the first 3 and 7 patients safety evaluations will be performed by
a data safety monitoring board. An interim analysis for response and safety as well as
maximum tolerated dose levels will occur after the first 7 patients have completed treatment
(Gehan timepoint). If the treatment is deemed clinically safe a further 13 patients will be

Inclusion Criteria:

- Male or female patients with CD23+, CD5+, CD19+ light chain monoclonal B-CLL with
treatment indication according to IWCLL criteria (Appendix 4)

- 1st or greater relapse after fludarabine or any other primary treatment regimen OR
Refractory to any previous treatment and simultaneous indication for treatment
according to IWCLL criteria (Appendix 4)

- Age 18 years and older

- ECOG status 0 - 2

- Life expectancy > 6 months

- Written informed consent given by the patient

- Patient using a reliable means of contraception (e.g. physical barrier, contraceptive
pill or patch, spermicide and barrier, or IUD) for the duration of the study. Male
patients have to use an adequate contraception method for the duration of study
treatment and for 6 months following completion of study treatment. Women of
childbearing potential have to use an effective method of contraception for the
duration of study participation.

Exclusion Criteria:

- HIV positive or positive for Hepatitis B or C

- Active uncontrolled infection

- Pregnant or lactating women

- Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or to
the excipients of any of the applied drugs (e.g. Bendamustine hydrochloride or

- Previous treatment with bendamustine

- Treatment with an experimental drug within the previous 2 months

- Patients with a history of other malignancies within 2 years prior to study entry,
except for adequately treated carcinoma in situ of the cervix; basal or squamous cell
skin cancer; low grade, early stage localized prostate cancer treated surgically with
curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with
curative intent.

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

- Decreased kidney function with creatinine clearance < 30 ml/min

- Patients with severe co-morbidities or major organ dysfunctions (e.g. known severe
liver damage, jaundice)

- Patients with a history of severe cardiac disease; e.g. NYHA Functional Class III or
IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias
requiring ongoing treatment, or unstable angina

- Any co-existing medical or psychological condition that would preclude participation
in the study or compromise ability to give informed consent, or patients unable to
comply with requirements of study protocol

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the percentage of patients achieving a response, defined as the percentage of patients achieving complete response, partial response and stable disease/ no change upon treatment with the combination therapy

Outcome Time Frame:

2 -16 months

Safety Issue:


Principal Investigator

Richard Greil, Prof.Dr.

Investigator Role:

Study Chair

Investigator Affiliation:

Arbeitsgemeinschaft medikamentoese Tumortherapie


Austria: Agency for Health and Food Safety

Study ID:

AGMT CLL-6 BendAlem



Start Date:

March 2009

Completion Date:

June 2013

Related Keywords:

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • CLL
  • pretreated
  • immune therapy
  • dose escalation
  • maintenance therapy
  • Bendamustine
  • Alemtuzumab
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid