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Trial record 47 of 1150 for:    "Follicular lymphoma"

A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients (PACIFICO)

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ClinicalTrials.gov Identifier: NCT01303887
Recruitment Status : Unknown
Verified October 2010 by University of Liverpool.
Recruitment status was:  Recruiting
First Posted : February 25, 2011
Last Update Posted : May 6, 2011
Sponsor:
Collaborators:
Royal Liverpool and Broadgreen University Hospitals NHS Trust
Cancer Research UK
Roche Pharma AG
Information provided by:
University of Liverpool

Tracking Information
First Submitted Date  ICMJE February 24, 2011
First Posted Date  ICMJE February 25, 2011
Last Update Posted Date May 6, 2011
Study Start Date  ICMJE October 2009
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
  • Toxicity [ Time Frame: 36 months ]
    The second primary outcome measure is grade 3-4 infection occurring anytime from the start of treatment until 6 months following the last dose of treatment, and this will be used as the toxicity end-point. Toxicity will be measured according to standard National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 following each cycle of treatment and at each subsequent follow-up visit until 6 months following the last dose of treatment.
  • Progression-free survival [ Time Frame: 30 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Progression free survival (PFS) [ Time Frame: Screening; End of Cycle 4; End of Cycle 8; 2 months after each Maintenance cycle; As soon as progression suspected ]
    The first primary outcome measure is length of progression-free survival defined as number of the days between date of randomisation and the date of progression or date of death from any cause.
  • Toxicity [ Time Frame: Baseline; Prior to each induction cycle; End of Cycle 4; End of Cycle 8; Prior to each Maintenance Cycle; 2 months after each Maintenance Cycle; Up to 28 days after last dose of treatment ]
    The second primary outcome measure is grade 3-4 infection occurring anytime from the start of treatment until 6 months following the last dose of treatment, and this will be used as the toxicity end-point. Toxicity will be measured according to standard National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 following each cycle of treatment and at each subsequent follow-up visit until 6 months following the last dose of treatment.
Change History Complete list of historical versions of study NCT01303887 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2011)
  • Response rates (overall, complete and partial) following initial therapy [ Time Frame: 24 weeks ]
  • Response rates following maintenance therapy [ Time Frame: 30 months ]
  • Response duration [ Time Frame: 30 months ]
  • Overall survival [ Time Frame: End of study ]
  • Time to next treatment [ Time Frame: End of study ]
  • Rate of large cell transformation [ Time Frame: End of study ]
  • Response to second-line therapy [ Time Frame: 30 months ]
  • Number of treatment cycles delivered [ Time Frame: 30 months ]
  • Cumulative dose of individual drugs administered [ Time Frame: 30 months ]
  • Quality of life [ Time Frame: End of study ]
  • Cost effectiveness [ Time Frame: End of study ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2011)
  • Response rates (overall, complete and partial) following initial therapy [ Time Frame: Screening; End of Cycle 4; End of Cycle 8; 2 months after each Maintenance cycle; As soon as progression suspected ]
  • Response rates following maintenance therapy [ Time Frame: Screening; End of Cycle 4; End of Cycle 8; 2 months after each Maintenance cycle; As soon as progression suspected ]
  • Response duration [ Time Frame: Screening; End of Cycle 4; End of Cycle 8; 2 months after each Maintenance cycle; As soon as progression suspected ]
  • Overall survival [ Time Frame: Every 4 months in Follow-Up ]
  • Time to next treatment [ Time Frame: Every 4 months in Follow-Up ]
  • Rate of large cell transformation [ Time Frame: Screening; End of Cycle 4; End of Cycle 8; 2 months after each Maintenance cycle; As soon as progression suspected ]
  • Response to second-line therapy [ Time Frame: Every 4 months in Follow-Up ]
  • Number of treatment cycles delivered [ Time Frame: End of Maintenance or sooner if patient is withdrawn ]
  • Cumulative dose of individual drugs administered [ Time Frame: End of Maintenance or sooner if patient is withdrawn ]
  • Quality of life [ Time Frame: Baseline; End of Cycle 4; End of Cycle 8; Every 4 months during Maintenance and Follow-Up ]
  • Cost effectiveness [ Time Frame: Baseline; End of Cycle 4; End of Cycle 8; Every 4 months during Maintenance and Follow-Up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Looking at Rituximab and Chemotherapy as a Treatment for Follicular Lymphoma in Elderly Patients
Official Title  ICMJE Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC
Brief Summary The purpose of this study is to determine whether R-FC is more beneficial that R-CVP in the treatment of older patients (aged 60 or over) with Follicular Lymphoma (FL).
Detailed Description FL predominantly affects the elderly, yet the optimum treatment for older patients with the disease has not been defined. The present study aims to address this question by comparing the drug combination that is currently considered the gold-standard (R-CVP) with a newer combination (R-FC) that might be more effective without being significantly more toxic. In order to take into account the balance between efficacy and toxicity, a dual primary endpoint has been employed: progression-free survival and toxicity in the form of grade 3-4 infection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Follicular Lymphoma
Intervention  ICMJE
  • Drug: Rituximab
    Rituximab 375mg/m2 IV day 1,repeated every 21 days for 8 cycles. All patients who have achieved a CR or PR to induction therapy will receive rituximab maintenance (375mg/m2 every 2 months for 2 years).
    Other Name: Mabthera
  • Drug: Cyclophosphamide
    Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
    Other Name: Cyclophosphamide monohydrate
  • Drug: Vincristine
    Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
    Other Name: vincristine sulfate
  • Drug: Prednisolone
    Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
    Other Name: Deltacortril
  • Drug: Fludarabine
    Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
    Other Name: Fludara
Study Arms  ICMJE
  • Active Comparator: R-CVP
    Repeated every 21 days for up to 8 cycles with response assessment after 4 cycles. Responders (PR/CR) after 8 cycles will receive Rituximab maintenance therapy for 2 years (12 bi-monthly cycles).
    Interventions:
    • Drug: Rituximab
    • Drug: Cyclophosphamide
    • Drug: Vincristine
    • Drug: Prednisolone
  • Experimental: R-FC
    Repeated every 21 days for 4 cycles. Responders (PR/CR) after 4 cycles will receive 4 further cycles of Rituximab only. Responders after 8 cycles will receive Rituximab maintenance therapy for 2 years (12 bi-monthly cycles).
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: Fludarabine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 24, 2011)
680
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2016
Estimated Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed follicular lymphoma (grade 1,2, and 3a with material available for central review)
  • Ann Arbor stage II-IV
  • Aged 60 years or over, or aged less than 60 but anthracycline-based therapy contra-indicated
  • No prior systemic therapy (one episode of prior local radiotherapy is allowed)
  • At least one of the following criteria for initiation of treatment:
  • Rapid generalized disease progression in the preceding 3 months
  • Life threatening organ involvement
  • Renal or macroscopic liver infiltration
  • Bone lesions
  • Presence of systemic symptoms or pruritus
  • Haemoglobin < 10 g/dL or WBC < 3.0 × 109/L or platelet counts < 100 × 109/L due to marrow involvement
  • Adequate haematological function (unless abnormalities are related to lymphoma infiltration of the bone marrow):
  • Haemoglobin ≥ 8.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 100 x 109/L
  • Written Informed Consent

Exclusion Criteria:

  • Overt transformation to diffuse large B-cell lymphoma
  • Grade 3b follicular lymphoma
  • Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
  • WHO performance status 3 or 4
  • Impaired renal function defined as estimated Glomerular filtration rate (eGFR) < 30 mL/min using the Modification of Diet in Renal Disease (MDRD) formula
  • Impaired hepatic function defined as serum bilirubin more than twice upper limit of normal (unless due to lymphoma or Gilbert's syndrome)
  • Life expectancy less than 12 months
  • Pre-existing neuropathy
  • Active auto-immune haemolytic anaemia
  • Serological evidence of infection with HIV, hepatitis B (positivity for surface antigen or core antibody) or hepatitis C
  • Allergy to murine proteins
  • Corticosteroid treatment during the last 4 weeks, unless administered at a dose equivalent to no more than prednisolone 20mg/day continuously or a single course of prednisolone 1 mg/kg for up to 7 days
  • Concomitant malignancies except adequately treated localised non-melanoma skin cancer or adequately treated in situ cervical cancer, or cancers that have been in remission for at least 5 years following surgery with curative intent.
  • Major surgery (excluding lymph node biopsy) within 28 days prior to randomisation
  • Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease)
  • Treatment within a clinical trial within 30 days prior to trial entry
  • Any other co-existing medical or psychological condition that will preclude participation in the study or compromise ability to give informed consent
  • Adult patient under tutelage (not competent to sign informed consent)
  • Pregnant or lactating women
  • All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01303887
Other Study ID Numbers  ICMJE ISRCTN99217456
2008-004759-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Andrew Pettitt, University of Liverpool
Study Sponsor  ICMJE University of Liverpool
Collaborators  ICMJE
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
  • Cancer Research UK
  • Roche Pharma AG
Investigators  ICMJE
Principal Investigator: Andrew Pettitt, Professor University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust
PRS Account University of Liverpool
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP