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Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Escalating Starting Dose of Lenalidomide and Concomitant Evaluation of Safety and Efficacy


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
CLL, Chronic Lymphocytic Leukemia

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Trial Information

Fludarabine/Rituximab Combined With Escalating Doses of Lenalidomide in Untreated Chronic Lymphocytic Leukemia (CLL) - a Dose-finding Study With Escalating Starting Dose of Lenalidomide and Concomitant Evaluation of Safety and Efficacy


Inclusion Criteria:



- Signed written informed consent

- Male or female ≥ 18 years of age

- CLL (as determined by CD23+, CD5+, CD19+)

- Treatment indication as defined by the NCI Workshop criteria (see appendix 6 and
reference 10)

- ECOG ≤ 2

- No previous treatment of the CLL by chemotherapy, radiotherapy (except localized
radiotherapy of 1 lymphatic area) or immunotherapy

- Life expectancy > 6 months (except prognosis due to high risk CLL)

Exclusion Criteria:

- Active bacterial, viral or fungal infection

- Positivity for HIV, Hepatitis B or C

- Patients with known history of thromboembolic events

- Reduced organ functions and bone marrow dysfunction not due to CLL

- Creatinine clearance of below 30 ml/min

- Patients with known history of thromboembolic events

- 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)

- Patients with medical co-morbid conditions that would require long term use (> 1
month) of systemic corticosteroids during study treatment

- 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

- Other known co-morbidity with the potential to dominate survival

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

- Hypersensitivity with anaphylactic reaction to humanised monoclonal antibodies or any
of the applied drugs

- Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol

- Administration of any investigational agent(s) within 4 weeks prior to entry

- Pregnancy or lactation

- Medical or psychological condition which in the opinion of the Investigator would not
permit the patient to complete the study or sign meaningful informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tolerability of escalated starting dose

Outcome Description:

Interim analysis after completion of cylce 1 of the first 5 patients, final analysis after last pastient last visit Metrics: Number of patients experiencing defined dose limiting toxicities during cycle 1

Outcome Time Frame:

12 month, 20 month

Safety Issue:

Yes

Authority:

Austria: Agency for Health and Food Safety

Study ID:

AGMT_CLL-9

NCT ID:

NCT01703364

Start Date:

September 2012

Completion Date:

Related Keywords:

  • CLL
  • Chronic Lymphocytic Leukemia
  • CLL
  • Lenalidomide
  • lenalidomide
  • Revlimid
  • AGMT
  • T cell
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

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