Who is sponsoring NCT00545714?

NCT00545714 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT00545714?

Interventions in NCT00545714: Cyclophosphamide, Fludarabine, Rituximab.

What condition does NCT00545714 study?

NCT00545714 studies Leukemia, Lymphocytic, Chronic, B-Cell.

Is NCT00545714 still recruiting?

NCT00545714 is currently completed. Last updated 16 January 2019.

Are results published for NCT00545714?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-01-16 · How we verify

NCT00545714

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Efficacy of Rituximab (MabThera) in First Line Treatment of Chronic Lymphocytic Leukemia (CLL)

Completed Phase 2 Results posted Last updated 16 January 2019

What this trial tests

Phase 2 trial testing Cyclophosphamide in Leukemia, Lymphocytic, Chronic, B-Cell in 86 participants. Completed in 20 May 2016.

Timeline

21 November 2007

Primary endpoint
20 May 2016

20 May 2016

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	86
Start date	21 November 2007
Primary completion	20 May 2016
Estimated completion	20 May 2016
Sites	33 locations across Spain

Drugs / interventions tested

Cyclophosphamide (cyclophosphamide) — full drug profile →
Fludarabine (FLUDARABINE) — full drug profile →
Rituximab — full drug profile →

Conditions studied

Leukemia, Lymphocytic, Chronic, B-Cell — all drugs for Leukemia, Lymphocytic, Chronic, B-Cell →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

Adults 18 to 70, any sex, with Leukemia, Lymphocytic, Chronic, B-Cell. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With CR Achieved After the Rituximab, Fludarabine, and Cyclophosphamide Regimen Primary · Month 9

CR was defined as no adenopathies (ADPs) and visceromegalies (VSMs) in physical examination (PE); no general symptoms (Sx); lymphocytes (Lymph) in peripheral blood less than (\<) 4000 per cubic millimeter (mm\^3); normalization of peripheral blood parameters: neutrophils (Neut) greater than (\>) 1500/mm\^3, platelets (Plt) \>100,000/mm\^3, hemoglobin (Hb) \>11 grams per deciliter (g/dL) without transfusion; normocellular bone marrow (BM) with \<30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules.

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	95.2	88.25 – 98.69

Percentage of Participants With Clinical Response of CR or PR as Assessed by Multiparameter Flow Cytometry Secondary · Post-Induction Phase (IP): at 6 months; during Maintenance Phase (MP): at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up (FU): at Follow-Up Months 6, 12, 18, 24, 30, 36

CR was defined as no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood \<4000/mm\^3; normalization of peripheral blood parameters: Neut \>1500/mm\^3, Plt \>100,000/mm\^3, Hb \>11 g/dL without transfusion; normocellular BM with \<30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR was defined as decrease \>50% in Lymph in peripheral blood; reduction in ADPs \>50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; \>50% decrease in VSM; Neut \>1500/mm\^3 or \>50% increase from Base

Post-IP: CR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	75.0

Post-IP: PR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	13.1

MP (9 Cycles): CR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	89.4

MP (9 Cycles): PR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	6.4

MP (12 Cycles): CR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	87.9

MP (12 Cycles): PR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	6.1

MP (15 Cycles): CR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	90.9

MP (15 Cycles): PR

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	4.5

Percentage of Participants With Clinical Response of CR or PR Among Participants With Negative Minimal Residual Disease (MRD) as Assessed by Multiparameter Flow Cytometry Secondary · Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 36

CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood \<4000/mm\^3; normalization of peripheral blood parameters: Neut \>1500/mm\^3, Plt \>100,000/mm\^3, Hb \>11 g/dL without transfusion; normocellular BM with \<30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules. PR: decrease \>50% in Lymph in peripheral blood; reduction in ADPs \>50% in total sum of up to 6 ADPs or in the baseline ADP of largest diameter (LD), no new ADP or enlargement of a prior ADP; \>50% decrease in VSM; Neut \>1500/mm\^3 or \>50% increase from Baseline; Plt \>100,000/mm\^3 or

Post-IP: Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

Post-IP: BM MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

MP (9 Cycles): Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

MP (12 Cycles): Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

MP (15 Cycles): Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

MP (18 Cycles): Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

6 Months FU: Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

12 Months FU: Blood MRD Negative

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

Percentage of Participants With CR With Incomplete Bone Marrow Recovery (CRi) Secondary · Baseline up to progressive disease (PD) or death due to any cause, whichever occurred first (up to 92 months)

Participants with CRi were those who met all CR criteria (including BM examinations) but had persistent anemia, thrombocytopenia, or neutropenia apparently unrelated to chronic lymphocytic leukemia (CLL) but related to drug toxicity. CR: no ADPs and VSMs in PE; no general Sx; Lymph in peripheral blood \<4000/mm\^3; normalization of peripheral blood parameters: Neut \>1500/mm\^3, Plt \>100,000/mm\^3, Hb \>11 g/dL without transfusion; normocellular BM with \<30% Lymph; BM aspirate/biopsy with no evidence of infiltration of lymphoid nodules.

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	7.1

Percentage of Participants Who Died Secondary · Baseline up to death due to any cause (up to 92 months)

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	23.2	5.72 – NA

Overall Survival (OS) Secondary · Baseline up to death due to any cause (up to 92 months)

OS was defined as time from treatment start to death of the participant. For all other participants, the last follow-up available was taken as the last control. If the participant had not completed the study, the date of the last visit available was considered. OS was estimated using Kaplan-Meier (KM) methodology.

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	7.51	7.5 – NA

Percentage of Participants With PD or Death Secondary · Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)

PD was defined as new ADPs (1.5 centimeters \[cm\]), hepato-/splenomegaly (HSM), Richter syndrome (RS), or other infiltrated organs; greater than or equal to (\>/=) 50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase \>/=50% in peripheral blood with B Lymph \>/=5000/mm\^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb \<10 g/dL, \>/=50% decrease in basal Plt count, or count \<100,000/mm\^3 at \>/=3 months post-treatment was defined as PD if BM biopsy confirme

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	39.29	5.72 – NA

Progression-Free Survival (PFS) Secondary · Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)

PFS was defined as time from start of study treatment to PD or death, whichever occurred first. For other participants, last follow-up available was taken as last control. If participant did not complete study, date of last visit available was considered. PFS was estimated using KM methodology. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; \>/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase \>/=50% in peripheral blood with B Lymph \>/=5000/mm\^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to a

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	6.96	5.72 – NA

Treatment-Free Survival (TFS) Secondary · Baseline up to PD or death due to any cause, whichever occurred first (up to 92 months)

TFS was defined time from start of study treatment until participant received new chemotherapy/immunotherapy because of PD and to reduce the disease with palliative or curative intent. PD was defined as new ADPs (1.5 cm), HSM, RS, or other infiltrated organs; \>/=50% increase in size of Baseline prior ADPs or HSM in participants with PR; Lymph increase \>/=50% in peripheral blood with B Lymph \>/=5000/mm\^3; cytopenia attributable to CLL. Progression of any cytopenia (not related to autoimmune cytopenia) reported as a 2-g/dL decrease in basal Hb, Hb \<10 g/dL, \>/=50% decrease in basal Plt cou

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	4.13	2.98 – 4.87

Duration of Response (DOR) Secondary · From first CR or PR up to detectable MRD or disease occurrence/PD, whichever occurred first (up to 92 months)

DOR: time from CR/PR to MRD/PD. PD: new ADP (1.5 cm), HSM, RS, other infiltrated organs or \>/=50% increase size in those with PR; blood Lymph increase \>/=50% with B Lymph \>/=5000/mm\^3; cytopenia due to CLL. Progression of (nonautoimmune) cytopenia: 2-g/dL decrease basal Hb, Hb \<10 g/dL, \>/=50% decrease basal Plt or \<100,000/mm\^3 at \>/=3 months post-treatment was PD if clonal CLL cell infiltration on BM biopsy. CR: no ADP/VSM in PE; no general Sx; blood Lymph \<4000/mm\^3; Neut \>1500/mm\^3; Plt \>100,000/mm\^3; Hb \>11 g/dL (no transfusion); normocellular BM with \<30% Lymph; BM aspir

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	NA	NA – NA

Percentage of Participants With Cluster of Differentiation (CD) 38 Cells >/=30% in Peripheral Blood Secondary · Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months); during Follow-Up: at Follow-Up Months 6, 12, 18, 24, 30, 36

Percentages of participants with CD38 expression by \>/=30% of CLL cells during the Induction Phase, Maintenance Phase, and Follow-Up were reported.

Post-IP

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	47.6

MP (9 Cycles)

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	44.4

MP (12 Cycles)

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	45.5

MP (15 Cycles)

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	47.6

MP (18 Cycles)

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	47.4

6 Months FU

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	66.7

12 Months FU

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	45.7

18 Months FU

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	100.0

Percentage of Participants With Genetic Abnormalities Secondary · Post-Induction Phase: at 6 months; during Maintenance Phase: at Cycles 9, 12, 15, 18 (cycle length = 2 months)

Percentages of participants with genetic abnormalities (deletion 6q, deletion 11q22-q23, deletion p53, trisomy 12, and deletion 13q14) in the course of the disease during the Induction Phase and Maintenance Phase were reported.

Post-IP: Deletion 6q

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	3.6

Post-IP: Deletion 11q22-q23

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	26.2

Post-IP: Deletion p53

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	4.8

Post-IP: Trisomy 12

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	15.5

Post-IP: Deletion 13q14

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	50.0

MP (9C): Deletion 6q

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	4.3

MP (9C): Deletion 11q22-q23

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	25.5

MP (9C): Deletion p53

Group	Value	95% CI
Rituximab + Fludarabine + Cyclophosphamide	0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline through end of Follow-Up (up to 92 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Rituximab + Fludarabine + Cyclophosphamide

Serious: 35/86 (41%)

Deaths: —

Serious adverse events (36 terms)

Reaction	System	Rituximab + Fludarabine + …
Febrile neutropenia	Blood and lymphatic system disorders	—
Pneumonia	Infections and infestations	—
Pyrexia	General disorders	—
Influenza	Infections and infestations	—
Respiratory tract infection	Infections and infestations	—
Anaemia	Blood and lymphatic system disorders	—
Neutropenia	Blood and lymphatic system disorders	—
Myocardial infarction	Cardiac disorders	—
Crohn's disease	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Malabsorption	Gastrointestinal disorders	—
Pancreatitis	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chest pain	General disorders	—
General physical health deterioration	General disorders	—
Cholelithiasis	Hepatobiliary disorders	—
Hepatic mass	Hepatobiliary disorders	—
Cytokine release syndrome	Immune system disorders	—
Gastroenteritis	Infections and infestations	—
Meningitis	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Sinusitis	Infections and infestations	—
Viral myocarditis	Infections and infestations	—
Jaw fracture	Injury, poisoning and procedural complications	—
Hypercalcaemia	Metabolism and nutrition disorders	—

Other adverse events (19 terms — click to expand)

Reaction	System	Rituximab + Fludarabine + …
Neutropenia	Blood and lymphatic system disorders	—
Pyrexia	General disorders	—
Nasopharyngitis	Infections and infestations	—
Nausea	Gastrointestinal disorders	—
Lymphopenia	Blood and lymphatic system disorders	—
Thrombocytopenia	Blood and lymphatic system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Leukopenia	Blood and lymphatic system disorders	—
Vomiting	Gastrointestinal disorders	—
Asthenia	General disorders	—
Respiratory tract infection	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Pneumonia	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Constipation	Gastrointestinal disorders	—
Chills	General disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Rash	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Febrile neutropenia, Pneumonia, Pyrexia, Influenza, Respiratory tract infection, Anaemia, Neutropenia, Myocardial infarction.

Data from ClinicalTrials.gov NCT00545714 adverse events section.

Sponsor's own description

This single arm study will assess the efficacy and safety of rituximab in combination with fludarabine and cyclophosphamide, followed by rituximab maintenance therapy, as first line treatment of participants with CLL.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

High prognostic value of measurable residual disease detection by flow cytometry in chronic lymphocytic leukemia patients treated with front-line fludarabine, cyclophosphamide, and rituximab, followed by three years of rituximab maintenance.
García-Marco JA, Jiménez JL, Recasens V, Zarzoso MF, et al · · 2019 · cited 6× · PMID 30890600 · DOI 10.3324/haematol.2018.204891

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00545714 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 16 January 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00545714.

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