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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01292603




Registration number
NCT01292603
Ethics application status
Date submitted
8/02/2011
Date registered
9/02/2011
Date last updated
19/12/2018

Titles & IDs
Public title
A Study to Compare Subcutaneous Versus Intravenous MabThera (Rituximab) in Combination With Chemotherapy in Patients With Chronic Lymphocytic Leukemia
Scientific 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
Secondary ID [1] 0 0
2010-021380-32
Secondary ID [2] 0 0
BO25341
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lymphocytic Leukemia, Chronic 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine
Treatment: Drugs - rituximab [MabThera]
Treatment: Drugs - rituximab [MabThera]
Treatment: Drugs - rituximab [MabThera]

Experimental: 1 -

Experimental: 2 -

Experimental: 3 -


Treatment: Drugs: Cyclophosphamide
Days 1-3 or Days 1-5 of cycles 1-6

Treatment: Drugs: Fludarabine
Days 1-3 or Days 1-5 of cycles 1-6

Treatment: Drugs: rituximab [MabThera]
One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera

Treatment: Drugs: rituximab [MabThera]
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.

Treatment: Drugs: rituximab [MabThera]
6 cycles of intravenous MabThera
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Subcutaneous Rituximab Dose Resulting in Trough Concentration (Ctrough) Levels Non-Inferior to Intravenous Rituximab
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
Part 2: Rituximab C Trough Levels at Cycle 5
Timepoint [2] 0 0
+/- 25hours around the 28th day post the 5th Cycle of Rituximab administration
Secondary outcome [1] 0 0
Part 2: Observed Area Under the Serum Concentration-Curve (AUC) of Rituximab at Cycle 6
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Part 2: Maximum Observed Concentration (Cmax) of Rituximab at Cycle 6
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Part 2: Time to Cmax (Tmax) of Rituximab at Cycle 6
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Part 2: Terminal Half-Life of Rituximab at Cycle 6
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Part 1: Percentage of Participants and Nurses Recording a Preference For Either SC or IV Administration
Timepoint [5] 0 0
Days 4 to 5 in Cycle 6
Secondary outcome [6] 0 0
Part 2: Physician/Nurse Opinion on Time Savings With Rituximab SC Compared With Rituximab IV
Timepoint [6] 0 0
Days 4-5 in Cycle 6
Secondary outcome [7] 0 0
Part 2: Physician/Nurse Opinion on Convenience of Rituximab SC Compared With Rituximab IV
Timepoint [7] 0 0
Days 4-5 in Cycle 6
Secondary outcome [8] 0 0
Part 1: Percentage of Participants With Anti-Rituximab Antibodies
Timepoint [8] 0 0
Predose at Cycles 5 and 6 and at each follow up visit until 24 months after the last dose
Secondary outcome [9] 0 0
Part 2: Percentage of Participants With Anti-Rituximab Antibodies
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Part 1: Total Cluster Differentiation19 Positive (CD19+) B-Cell Counts by Visit
Timepoint [10] 0 0
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
Secondary outcome [11] 0 0
Part 1: Percentage of Participants With Total B-Cell Depletion by Visit
Timepoint [11] 0 0
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
Secondary outcome [12] 0 0
Part 2: Total CD19+ B-Cell Counts by Visit
Timepoint [12] 0 0
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
Secondary outcome [13] 0 0
Part 2: Percentage of Participants With Total B-Cell Depletion by Visit
Timepoint [13] 0 0
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

Eligibility
Key inclusion criteria
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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:

* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/11/2017
Sample size
Target
Accrual to date
Final
240
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
St George Hospital; Department of Haematology - Kogarah
Recruitment hospital [2] 0 0
Royal Brisbane and Women'S Hospital; Haematology - Herston
Recruitment hospital [3] 0 0
Ashford Cancer Center Research - Kurralta Park
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital; Haematology - Woodville South
Recruitment hospital [5] 0 0
St Vincent'S Hospital; Haematology - Fitzroy
Recruitment hospital [6] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Córdoba
Country [3] 0 0
Brazil
State/province [3] 0 0
RS
Country [4] 0 0
Brazil
State/province [4] 0 0
SP
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Chile
State/province [7] 0 0
Santiago
Country [8] 0 0
Croatia
State/province [8] 0 0
Zagreb
Country [9] 0 0
Czechia
State/province [9] 0 0
Brno
Country [10] 0 0
Czechia
State/province [10] 0 0
Hradec Kralove
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 2
Country [12] 0 0
France
State/province [12] 0 0
Caen
Country [13] 0 0
France
State/province [13] 0 0
Marseille
Country [14] 0 0
France
State/province [14] 0 0
Paris
Country [15] 0 0
France
State/province [15] 0 0
Reims
Country [16] 0 0
France
State/province [16] 0 0
Vandoeuvre Les Nancy
Country [17] 0 0
Germany
State/province [17] 0 0
Berlin
Country [18] 0 0
Germany
State/province [18] 0 0
Dresden
Country [19] 0 0
Germany
State/province [19] 0 0
Frankfurt an der Oder
Country [20] 0 0
Germany
State/province [20] 0 0
Greifswald
Country [21] 0 0
Germany
State/province [21] 0 0
Hannover
Country [22] 0 0
Germany
State/province [22] 0 0
Kassel
Country [23] 0 0
Germany
State/province [23] 0 0
Köln
Country [24] 0 0
Germany
State/province [24] 0 0
Landshut
Country [25] 0 0
Germany
State/province [25] 0 0
Lübeck
Country [26] 0 0
Germany
State/province [26] 0 0
Marburg
Country [27] 0 0
Germany
State/province [27] 0 0
Muenchen
Country [28] 0 0
Germany
State/province [28] 0 0
München
Country [29] 0 0
Germany
State/province [29] 0 0
Neunkirchen/Saar
Country [30] 0 0
Germany
State/province [30] 0 0
Recklinghausen
Country [31] 0 0
Greece
State/province [31] 0 0
Athens
Country [32] 0 0
Greece
State/province [32] 0 0
Thessaloniki
Country [33] 0 0
Italy
State/province [33] 0 0
Emilia-Romagna
Country [34] 0 0
Italy
State/province [34] 0 0
Friuli-Venezia Giulia
Country [35] 0 0
Italy
State/province [35] 0 0
Lombardia
Country [36] 0 0
Italy
State/province [36] 0 0
Piemonte
Country [37] 0 0
Italy
State/province [37] 0 0
Veneto
Country [38] 0 0
Mexico
State/province [38] 0 0
Chihuahua
Country [39] 0 0
Mexico
State/province [39] 0 0
Culiacan
Country [40] 0 0
Mexico
State/province [40] 0 0
Monterrey
Country [41] 0 0
New Zealand
State/province [41] 0 0
Christchurch
Country [42] 0 0
New Zealand
State/province [42] 0 0
Newtown
Country [43] 0 0
Poland
State/province [43] 0 0
Gdansk
Country [44] 0 0
Poland
State/province [44] 0 0
Lublin
Country [45] 0 0
Poland
State/province [45] 0 0
Warszawa
Country [46] 0 0
Poland
State/province [46] 0 0
Wroclaw
Country [47] 0 0
Portugal
State/province [47] 0 0
Lisboa
Country [48] 0 0
Portugal
State/province [48] 0 0
Porto
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Moscow
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Penza
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Perm
Country [52] 0 0
Russian Federation
State/province [52] 0 0
Saint-Petersburg
Country [53] 0 0
Slovakia
State/province [53] 0 0
Bratislava
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Madrid
Country [56] 0 0
Spain
State/province [56] 0 0
Salamanca
Country [57] 0 0
Spain
State/province [57] 0 0
Sevilla
Country [58] 0 0
Spain
State/province [58] 0 0
Toledo
Country [59] 0 0
Spain
State/province [59] 0 0
Valencia
Country [60] 0 0
Turkey
State/province [60] 0 0
Ankara
Country [61] 0 0
Turkey
State/province [61] 0 0
Istanbul
Country [62] 0 0
Turkey
State/province [62] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT01292603