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Lymphocytic Leukemia, ChronicPhase 1NCT01292603

A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia

A Phase 1 study testing Cyclophosphamide, Fludarabine and rituximab [MabThera] in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 84 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphocytic Leukemia, Chronic
What is being tested?
Cyclophosphamide, Fludarabine and rituximab [MabThera]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
84 sitesin 19 countries
Study dates
18 Apr 2011to 17 Nov 2017
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, >/=18 years of age
  • Patients with treatment-requiring chronic lymphocytic leukemia (CLL)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Life expectancy >6 months

Who cannot join

  • Transformation to aggressive B-cell malignancy
  • History of other malignancy unless the patient was treated with curative intent and has been in remission for more than 5 years prior to enrolment
  • HIV or Hepatitis B positive unless clearly due to vaccination
  • Inadequate liver or renal function
  • Any coexisting medical or psychological condition that would preclude participation in the required study procedures
  • Additional exclusion criterion for Part 1:
Show all 9Show fewer
  • Any previous treatment for CLL except for up to 4 cycles of rituximab IV in combination with FC chemotherapy as first-line treatment for CLL
  • Additional exclusion criterion for Part 2:
  • Any previous treatment for CLL

Trial locations and contacts

84 sites in 19 countries.

84 sites in 19 countries

Germany15 sites

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch

    Berlin, 14195

  • Klinik der Uni zu Köln; Klinik für Innere Medizin

    Cologne, 50924

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie

    Dresden, 01307

  • Klinikum Frankfurt; Medizinische Klinik I

    Frankfurt (Oder), 15236

  • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

    Greifswald, 17475

  • Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.

    Hanover, 30171

  • Gemeinschaftspraxis Dr. Siehl & Dr. Soeling

    Kassel, 34119

  • K&K Studien GbR

    Landshut, 84028

  • Onkologische Schwerpunktpraxis Lübeck

    Lübeck, 23562

  • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

    Marburg, 35037

  • Medizinisches Versorgungszentrum MOP

    München, 80335

  • Klinikum Grosshadern der LMU

    München, 81377

  • Gemeinschaftspraxis Dr. med. Holger Klaproth / Dr. med. Anca Astrid Cura

    Neunkirchen/Saar, 66538

  • Prosper-Hospital, Medizinische Klinik I

    Recklinghausen, 45659

Other trials in Germany

Italy8 sites

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

    Meldola, Emilia-Romagna, 47014

  • Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

    Milan, Lombardy, 20132

  • ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Struttura Complessa di Ematologia

    Milan, Lombardy, 20162

  • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

    Novara, Piedmont, 28100

  • Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia

    Ravenna, Emilia-Romagna, 48100

  • Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia

    Rimini, Emilia-Romagna, 47900

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

    Udine, Friuli Venezia Giulia, 33100

  • Policlinico G. B. Rossi; Divisione Di Ematologia

    Verona, Veneto, 37134

Other trials in Italy

Spain7 sites

  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia

    Barcelona, 08035

  • Hospital Universitario de la Princesa; Servicio de Hematologia

    Madrid, 28006

  • Hospital Universitario Puerta de Hierro; Servicio de Hematologia

    Madrid, 28222

  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

    Salamanca, 37007

  • Hospital Universitario Virgen del Rocio; Servicio de Hematologia

    Seville, 41013

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Hematología

    Toledo, 45004

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

Other trials in Spain

Australia6 sites

  • St Vincent'S Hospital; Haematology

    Fitzroy, Victoria, 3065

  • Frankston Hospital; Oncology/Haematology

    Frankston, Victoria, 3199

  • Royal Brisbane and Women'S Hospital; Haematology

    Herston, Queensland, 4029

  • St George Hospital; Department of Haematology

    Kogarah, New South Wales, 2217

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Queen Elizabeth Hospital; Haematology

    Woodville South, South Australia, 5011

Other trials in Australia

Russia6 sites

  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

    Moscow, 115478

  • City Clinical Hospital After Botkin; Hematology

    Moscow, 125101

  • Haematology Research Center; Haematology

    Moscow, 125167

  • Penza Regional Oncology Dispensary

    Penza, 440071

  • Clinical MSCh No1

    Perm, 614077

  • St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

    Saint Petersburg, 197022

Other trials in Russia

France5 sites

  • Centre Francois Baclesse

    Caen, 14076

  • Institut J Paolii Calmettes; Onco Hematologie 1

    Marseille, 13273

  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

    Paris, 75475

  • Hopital Robert Debre; Hematologie Clinique

    Reims, 51092

  • Hopitaux De Brabois; Hematologie Medecine Interne

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Brazil4 sites

  • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Hospital Sirio Libanes; Centro de Oncologia

    São Paulo, São Paulo, 01308-050

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Canada4 sites

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • Centre de sante et de services sociaux Rimouski Neigette

    Rimouski, Quebec, G5L 5T1

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

Poland4 sites

  • Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii

    Gdansk, 80-952

  • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

    Lublin, 20-081

  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

    Warsaw, 02-781

  • Medical Uni of Wroclaw; Hematology

    Wroclaw, 50-367

Other trials in Poland

Turkey (Türkiye)4 sites

  • Hacettepe Uni Medical Faculty; Hematology

    Ankara, 06100

  • Istanbul University Cerrahpasa Medical Faculty; Hematology Department

    Istanbul, 34098

  • Dokuz Eylul Uni ; Hematology

    Izmir, 35100

  • Ege University ARGEFAR

    Izmir, 35100

Other trials in Turkey (Türkiye)

Argentina3 sites

  • Fundaleu; Haematology

    Buenos Aires, C1114AAN

  • Cemic; Haematology

    Buenos Aires, C1431FWO

  • HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

    Córdoba, 5016

Other trials in Argentina

Czechia3 sites

  • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika

    Brno, 625 00

  • University Hospital and Medical School; IV.Dept. of Internal Medicine and Hematology

    Hradec Králové, 500 05

  • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK

    Prague, 128 08

Other trials in Czechia

Mexico3 sites

  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

    Chihuahua City, 31000

  • Hospital General De Culiacan; Servicio De Hematologia

    Culiacán, 80230

  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology

    Monterrey, 64460

Other trials in Mexico

Chile2 sites

  • Instituto Nacional del Cancer

    Santiago, 8380000

  • Centro Internacional de Estudios Clínicos (CIEC)

    Santiago, 8420383

Other trials in Chile

Croatia2 sites

  • Clinical Hospital Merkur; Dept of Haematology

    Zagreb, 10000

  • University Hospital Center Zagreb; Haematology Department

    Zagreb, 10000

Other trials in Croatia

Greece2 sites

  • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

    Athens, 115 27

  • Papageorgiou General Hospital of Thessaloniki; Hematology Clinic

    Thessaloniki, 54629

Other trials in Greece

New Zealand2 sites

  • Canterbury Health Laboratories; Haematology

    Christchurch, 8011

  • Wellington Hospital; Wellington Blood and Cancer Centre

    Newtown, 6021

Other trials in New Zealand

Portugal2 sites

  • Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula

    Lisbon, 1600

  • IPO do Porto; Servico de Onco-Hematologia

    Porto, 4200-072

Other trials in Portugal

Slovakia2 sites

  • National Oncology Inst. ; Dept. of Haematology

    Bratislava, 833 10

  • University Hospital; Clinic of Hematology & Transfusiology

    Bratislava, 851 07

Other trials in Slovakia

About this study

Official title: An Adaptive, Comparative, Randomized, Parallel-group, Multi Center, Phase Ib Study of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With Chemotherapy (Fludarabine and Cyclophosphamide), in Patients With Previously Untreated CLL

This randomized, parallel-group, multi-center study will compare the pharmacokinetics and safety of subcutaneous administration of MabThera (rituximab) versus intravenous MabThera in combination with chemotherapy in previously untreated patients with chronic lymphocytic leukemia (CLL). The study consists of 2 parts. In part 1, patients who have previously received 4 cycles of intravenous MabThera will receive in Cycle 5 intravenous MabThera and in Cycle 6 subcutaneous MabThera. In part 2, patients will be randomized to receive either 6 cycles of intravenous MabThera, or 1 cycle of intravenous MabThera and 5 cycles of subcutaneous MabThera. Additionally, all patients will receive chemotherapy (fludarabine and cyclophosphamide) on Days 1-3 or Days 1-5 of every cycle. The anticipated time on study drug is 24 weeks.

Being tested
Cyclophosphamide, Fludarabine, rituximab [MabThera]
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Days 1-3 or Days 1-5 of cycles 1-6

  • FludarabineDrug

    Days 1-3 or Days 1-5 of cycles 1-6

  • rituximab [MabThera]Drug

    One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera

  • rituximab [MabThera]Drug

    After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.

  • rituximab [MabThera]Drug

    6 cycles of intravenous MabThera

Study groups in NCT01292603
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: rituximab [MabThera]
2ExperimentalNot described
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: rituximab [MabThera]
3ExperimentalNot described
Receives: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: rituximab [MabThera]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab

    Ctrough is defined as the trough or minimum serum concentration. Pharmacokinetic parameters for rituximab were assessed during Cycles 5 (IV rituximab) and 6 (SC rituximab). Rituximab pharmacokinetic (PK) data from Part 1 were integrated into a population PK model using parametric, nonlinear, mixed-effects modelling. Rituximab IV 500 mg/m^2 administered once every 4 weeks was compared to fixed doses of rituximab SC between 1400 mg and 1870 mg. The dose selection was performed on Ctrough concentrations at Cycle 5 (pre-dose Cycle 6). A test of the probability of success was applied to each of the 100 replicates, and the percentage of replicates with a positive test corresponded to the probability of success of the trial.

    Measured: Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose

  2. Part 2: Rituximab C Trough Levels at Cycle 5

    Ctrough is defined as the trough or minimum serum concentration in a given cycle of treatment. The objective of Part 2 was to demonstrate the comparability of the observed Ctrough of rituximab SC 1600 mg and rituximab IV 500 mg/m2 at Cycle 5, as assessed by a non-inferiority test with a lower boundary of at least 0.8 for the 90% CI.

    Measured: +/- 25hours around the 28th day post the 5th Cycle of Rituximab administration

Secondary outcomes (13)

  1. Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6

    AUC values were calculated by numerical integration using the linear trapezoidal rule. AUC levels were analyzed using the model below: Ln(AUC) = μ + τi + BlTLij + εij wherein, Ln is the natural log, μ denotes the overall mean effect, τi the effect in each treatment group, BlTLij the tumor load at baseline for each patient and εij a random error variable with normal distribution and mean 0. The treatment effect therein was based on a contrast statement in the model to calculate 90 % confidence intervals for ln(AUC SC)- ln(AUC IV).

    Measured: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6

  2. Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6

    Cmax was obtained directly from the measured concentration-time curves. The concentration-time curve is the result of time points of blood sampling and its measured concentration of rituximab in the blood samplings.

    Measured: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6

  3. Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6

    Multiple blood samples were obtained at pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab IV arm, and at pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6 in Rituximab SC arm and time to peak plasma concentration of rituximab was determined.

    Measured: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6

  4. Part 2: Terminal Half-Life of Rituximab at Cycle 6

    The terminal half-life (t1/2) of rituximab is defined as the time required for the plasma concentration of rituximab to reach half of its original concentration.

    Measured: Rituximab IV arm: pre-dose, post-dose and on Days 2, 3, 8 ,15, 29 of Cycle 6; Rituximab SC arm: pre-dose, and on Days 2, 3, 8 ,15, 29 of Cycle 6

  5. Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration

    In part 1 of the trial, upon completion of dosing in cycle 6, participants and their treating nurses were asked whether they have a preference of dosing route, IV vs SC

    Measured: Days 4 to 5 in Cycle 6

  6. Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV

    Physicians and nurses who administered rituximab were asked to answer the following question: " If used in routine practice, on average, how much staff time could be saved with each administration of rituximab SC as compared to rituximab IV? (Please do not consider the time needed for the first IV administration, consider only the subsequent ones)". The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.

    Measured: Days 4-5 in Cycle 6

  7. Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV

    Physicians and nurses who administered rituximab were asked to answer the following question: "Which formulation of rituximab (SC or IV) do you think is more convenient?" with pre-specified responses as below. Percentage of participants with specified answers were reported. The number of nurses that responded for both the IV and SC arms was 70. The number of physicians that responded for the IV and SC arms were 78 and 81 respectively.

    Measured: Days 4-5 in Cycle 6

  8. Part 1: Percentage of Participants With Anti-Rituximab Antibodies

    Blood samples for the assessment of antibodies against rituximab (HACAs) were drawn pre-dose at Cycle 5 and Cycle 6 in Part 1 and at each follow up visit until 24 months after the last dose.

    Measured: Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose

  9. Part 2: Percentage of Participants With Anti-Rituximab Antibodies

    In Part 2, samples for the HACA assay were collected at each treatment cycle prior to the administration of rituximab and at each follow-up visit until 24 months after the last dose of rituximab.

    Measured: Day 0 of Cycle 1 and Day 1 of Cycles 1, 2, 3, 4, 5, and 6 and at each follow-up visit until 24 months after the last dose of rituximab.

  10. Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit

    CD 19 is a surface antigen (protein) present on B-lymphocytes.

    Measured: Day 1 of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15,18, 21 and 24

  11. Part 1: Percentage of Participants With Total B-Cell Depletion by Visit

    Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.

    Measured: Day 1 pre-dose of Cycles 5 and 6 and Follow-up Days 28 and 56 and Follow-up Visits at Months 3, 6, 9, 12, 15, 18, 21 and 24

  12. Part 2: Total CD19+ B-Cell Counts by Visit

    CD 19 is a surface antigen (protein) present on B-lymphocytes.

    Measured: Cycle 1 pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 pre-dose in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit

  13. Part 2: Percentage of Participants With Total B-Cell Depletion by Visit

    Total B-cell depletion (normal B-cell plus Malignant B-cell depletion) was defined for each individual participant when the sum of CD5-/CD19+ (normal B-cells) and CD5+/CD19+ (malignant B-cells) cell counts decreased below 80 cells/μL.

    Measured: Cycle 1 Pre-dose, 60 minutes post-dose, Days 2 and 3 in Cycle 2, day 1 in Cycles 3, 4, 5 and 6, Follow-up Days 28 and 56, and Follow-up Visits at Months 3, 6, 9, 12, 15, and 18 and Withdrawal Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2011 (estimated)
  2. Study start18 Apr 2011
  3. Primary completion7 May 2014
  4. Study completion17 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01292603
Sponsor's protocol ID
BO25341
Other IDs
2010-021380-32
Status last verified
Nov 2018
First submitted
8 Feb 2011
Last updated
19 Dec 2018

Publications

  • Assouline S, Buccheri V, Delmer A, Gaidano G, Trneny M, Berthillon N, Brewster M, Catalani O, Li S, McIntyre C, Sayyed P, Badoux X. Pharmacokinetics, safety, and efficacy of subcutaneous versus intravenous rituximab plus chemotherapy as treatment for chronic lymphocytic leukaemia (SAWYER): a phase 1b, open-label, randomised controlled non-inferiority trial. Lancet Haematol. 2016 Mar;3(3):e128-38. doi: 10.1016/S2352-3026(16)00004-1.

    PubMed 26947201

  • Assouline S, Buccheri V, Delmer A, Gaidano G, McIntyre C, Brewster M, Catalani O, Hourcade-Potelleret F, Sayyed P, Badoux X. Pharmacokinetics and safety of subcutaneous rituximab plus fludarabine and cyclophosphamide for patients with chronic lymphocytic leukaemia. Br J Clin Pharmacol. 2015 Nov;80(5):1001-9. doi: 10.1111/bcp.12662. Epub 2015 Jul 29.

    PubMed 25900065

  • Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.

    PubMed 24265828

  • Shpilberg O, Jackisch C. Subcutaneous administration of rituximab (MabThera) and trastuzumab (Herceptin) using hyaluronidase. Br J Cancer. 2013 Sep 17;109(6):1556-61. doi: 10.1038/bjc.2013.371. Epub 2013 Sep 3.

    PubMed 24002601

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide, Fludarabine and rituximab [MabThera] in people with Lymphocytic Leukemia, Chronic, run by Hoffmann-La Roche at 84 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in Germany, Italy, Spain, Australia, Russia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab (time frame: Pre-dose and post-dose (15 minutes to end of infusion) on Day 1 and on Days 2, 5, 11 and 15 of Cycle 5 and Pre-dose, Post-dose on Days 2, 3, 5,11, 15 and 29 of Cycle 6; Pre-dose was taken 2 hours prior rituximab dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01292603, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.

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