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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01271010
Other study ID # ML25136
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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