Know Cancer

or
forgot password

A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia


Phase 2
65 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic

Thank you

Trial Information

A Phase II, Multicenter, Single Arm Study to Determine the Efficacy and Safety of Low Dose Fludarabine and Cyclophosphamide Combined With Standard Dose Rituximab as Primary Therapy in Elderly Untreated Patients (>/=65 Years Old) With Chronic Lymphocytic Leukemia


Inclusion Criteria:



- Adult patients, >/= 65 years of age

- Previously untreated B-cell chronic lymphocytic leukemia (CLL)

- Binet stage C or active Binet stage A and B disease

Exclusion Criteria:

- Prior treatment for CLL

- CLL with transformation (Richter's syndrome)

- Suspected or known CNS involvement of CLL

- Impaired renal or hepatic function

- HIV positivity, active hepatitis B/C, or any active or uncontrolled infections

- Concomitant diseases requiring chronic steroid administration

- Active second malignancy within the 2 years prior to study (except for non-melanoma
skin cancer and in situ cervix or breast carcinoma)

- ECOG performance status >/= 4

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall Response Rate (according to National Cancer Institute - Working Group [NCI-WG] guidelines)

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Israel: Ministry of Health, Pharmaceutical Administration

Study ID:

ML25464

NCT ID:

NCT01263704

Start Date:

July 2011

Completion Date:

June 2016

Related Keywords:

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

Name

Location