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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Liverpool University Hospitals NHS Foundation Trust
Cancer Research UK
Roche Pharma AG
Information provided by:
University of Liverpool

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).

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Rituximab Drug: Cyclophosphamide Drug: Vincristine Drug: Prednisolone Drug: Fludarabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Purine-Alkylator Combination In Follicular Lymphoma Immuno-Chemotherapy for Older Patients: a Phase III Comparison of First-line R-CVP Versus R-FC
Study Start Date : October 2009
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Rituximab

Arm Intervention/treatment
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).
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

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).
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: Fludarabine
Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
Other Name: Fludara

Primary Outcome Measures :
  1. 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.

  2. Progression-free survival [ Time Frame: 30 months ]

Secondary Outcome Measures :
  1. Response rates (overall, complete and partial) following initial therapy [ Time Frame: 24 weeks ]
  2. Response rates following maintenance therapy [ Time Frame: 30 months ]
  3. Response duration [ Time Frame: 30 months ]
  4. Overall survival [ Time Frame: End of study ]
  5. Time to next treatment [ Time Frame: End of study ]
  6. Rate of large cell transformation [ Time Frame: End of study ]
  7. Response to second-line therapy [ Time Frame: 30 months ]
  8. Number of treatment cycles delivered [ Time Frame: 30 months ]
  9. Cumulative dose of individual drugs administered [ Time Frame: 30 months ]
  10. Quality of life [ Time Frame: End of study ]
  11. Cost effectiveness [ Time Frame: End of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01303887

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Contact: Kathryn Marley +44 (0)151 794 8897
Contact: James Dodd +44 (0)151 795 5288

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Sponsors and Collaborators
University of Liverpool
Liverpool University Hospitals NHS Foundation Trust
Cancer Research UK
Roche Pharma AG
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Principal Investigator: Andrew Pettitt, Professor University of Liverpool and Royal Liverpool and Broadgreen University Hospitals Trust
Additional Information:
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Responsible Party: Professor Andrew Pettitt, University of Liverpool Identifier: NCT01303887    
Other Study ID Numbers: ISRCTN99217456
2008-004759-31 ( EudraCT Number )
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: May 6, 2011
Last Verified: October 2010
Keywords provided by University of Liverpool:
Follicular Lymphoma
Non-Hodgkin's Lymphoma
Additional relevant MeSH terms:
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Lymphoma, Follicular
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Anti-Inflammatory Agents