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

Lymphocytic Leukemia, Chronic Clinical Trial

Official title:

Prospective Study of Efficacy and Safety of RFC (Rituximab, Fludarabine, Cyclophosphamide) Regimen as a First-Line Therapy in Patients With B-Cell Chronic Lymphocytic Leukemia and Favorable Somatic Status

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01271010
• Other study ID #: ML25136
• Status: Terminated
• Phase: Phase 4
• First received: January 4, 2011
• Last updated: August 22, 2017
• Start date: June 17, 2011
• Est. completion date: May 4, 2016

Study information

• Verified date: August 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 89
• Est. completion date: May 4, 2016
• Est. primary completion date: May 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cyclophosphamide
Participants received cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle.
• Fludarabine
Participants received fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle.
• Rituximab
Participants received 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle.

Locations

Country	Name	City	State
Russian Federation	The order of Honour pin Irkutsk regional clinical hospital; Hematology Department	Irkutsk
Russian Federation	Kemerovo Regional Clinical Hospital	Kemerovo
Russian Federation	Regional Clinical Oncology Despensary #1; Hematology Department	Krasnodar
Russian Federation	City Clinical Hospital After Botkin; Hematology	Moscow
Russian Federation	N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis	Moscow
Russian Federation	City Clinical Hospital #15; Hematology department	Saint-Petersburg
Russian Federation	Leningrad Regional Clinical Hospital; Hematology #1	St Petersburg
Russian Federation	Saint-Petersburg SHI City Clinical Hospital #31	St. Petersburg
Russian Federation	GUZ Tula Regioanal Clinical Hospital; Hematology	Tula
Russian Federation	Republican clinical hospital named after G.G. Kuvatov	UFA

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Complete Remission	Complete remission was defined as the disappearance of all signs of disease.	Up to approximately 5 years
Primary	Percentage of Participants With Disease Progression	Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.	Up to approximately 5 years
Primary	Percentage of Participants With Stable Disease	Stable disease was defined as not meeting the criteria for partial remission or disease progression	Up to approximately 5 years
Primary	Percentage of Participants With Partial Remission	Partial remission was defined as a reduction in tumor size by >50%.	Up to approximately 5 years
Primary	Duration of Response	Duration of Response was defined as the time period from the last day of study treatment to the day when disease progression occurred in participants who previously had complete or partial remission. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.	Up to approximately 5 years
Primary	Progression-free Survival	Progression-free survival was defined as the time period from the first day of study treatment to the day when disease progression occurred. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen.	Up to approximately 5 years
Primary	Event-free Survival	Event-free survival was defined as the time period from the first day of study treatment to occurrence of any of the following events: appearance of disease progression or relapse; prescription of a new treatment for disease relapse; death caused by B-cell chronic lymphocytic leukemia (B-CLL); or complications from B-CLL or therapy. Relapse was defined as disease progression in participants with complete or partial remission lasting at least 6 months after treatment completion. Disease progression was defined as an increase in lymphocytosis, or enlargement of the lymph nodes or spleen. Complete remission was defined as the disappearance of all signs of disease. Partial remission was defined as a reduction in tumor size by >50%.	Up to approximately 5 years
Primary	Overall Survival	Overall survival was defined as the time period from the first day of study treatment to participant death.	Up to approximately 5 years
Primary	Percentage of Participants With Phenotypic Remission	Phenotypic remission was considered achieved if a participant had a negative test for minimal residual disease. A negative test for minimal residual disease was defined as tumor cells =0.01% of the total number of peripheral leukocytes.	Up to approximately 5 years
Primary	Percentage of Participants With Adverse Events (AEs) and Serious AEs	An AE was defined as any unfavorable medical occurrence in a participant receiving a study drug, regardless of relationship the study drug. An AE was considered serious if it met any of the following criteria: was fatal or life-threatening; required hospitalization or prolonged hospitalization; led to persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was clinically significant and/or required an intervention to prevent any of the listed criteria.	Up to approximately 5 years