Know Cancer

or
forgot password

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Chronic Lymphocytic Leukemia

Thank you

Trial Information

Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV


Inclusion Criteria:



- histologically or immunologically confirmed chronic B-cell leukemia

- refractory (i.e. no response or progression during initial chemotherapy) or relapsed
situation after first-line treatment regimen

- disease stage II-IV according to Rai or B/C according to Binet staging system,
respectively

- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better

- negative pregnancy test/ adequate method of contraception

Exclusion Criteria:

- T-CLL, PLL (prolymphocytic leukemia)

- presence of Richter's transformation

- first-line treatment containing either fludarabine or bendamustine

- acute infections or distinctly reduced organ function precluding the application of
chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system
(creatinine > 2 mg/dl), or metabolic disorders

- secondary malignancy (except for curative treated basal cell carcinoma or cervical
cancer)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Description:

individual time-frame up to max. follow-up (Kaplan-Meier estimation)

Outcome Time Frame:

the patients were followed on average for 36 months

Safety Issue:

No

Principal Investigator

Norbert Niederle, Prof, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Med. Klinik III, Klinikum Leverkusen gGmbH, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

WISP_RI05

NCT ID:

NCT01423032

Start Date:

September 2001

Completion Date:

May 2009

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • relapsed
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location