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A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status
A Study of Rituximab in Combination With Fludarabine and Cyclophosphamide in Participants With Chronic Lymphocytic Leukemia and Favorable Somatic Status

NCT01271010

TerminatedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Lymphocytic Leukemia, Chronic

Interventions: Cyclophosphamide, Fludarabine, Rituximab

Countries: Russia

This multi-center, single-arm study evaluated the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide in participants with B-cell chronic lymphocytic leukemia (CLL) and favorable somatic status.

Eligibility overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of previously untreated B-cell CLL confirmed immunophenotypically
* For participants, age 60-70 years: Cumulative Illness Rating Scale (CIRS) comorbidity score less than or equal to (\</=) 6
* Binet stage B, C or A with progression
* Life expectancy greater than or equal to (\>/=) 12 months
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Women of child bearing potential and men should agree to use highly reliable contraceptive method throughout the treatment period and within 12 months after treatment completion

Exclusion Criteria:

* Participants with small-cell lymphoma
* Participants with auto-immune hemolytic anemia
* Concomitant malignant disease during enrollment, except basal cell carcinoma of the skin
* Chemotherapy for concomitant malignant disease given within 12 months prior to study enrollment
* Participants with Richter's Syndrome
* Participants with symptomatic Hepatitis B infection
* Any clinically significant infection that could not be cured prior to enrollment, including Human Immunodeficiency Virus (HIV) infection
* Creatinine clearance less than (\<) 30 milliliters per minute (mL/min)
* Participants with congestive heart failure (CHF) New York Heart Association (NYHA) III-IV
* Participants with liver failure and acute hepatitis of any etiology
* Any other medical or mental condition which may preclude from receiving the entire course of protocol specified treatment or signing the informed consent
* History of an anaphylactic reaction to murine antibodies, proteins, or any other ingredient of rituximab
* Pregnancy and breast-feeding women
Locations (10)
  • Irkutsk, Russia
  • Kemerovo, Russia
  • Krasnodar, Russia
  • Moscow, Russia
  • Moscow, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Saint Petersburg, Russia
  • Tula, Russia
  • Ufa, Russia