Non Hodgkin LymphomaPhase 2NCT00185445
Efficacy and Safety Study of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
A Phase 2 study testing Fludarabine Phosphate (Fludara) in people with Non Hodgkin Lymphoma, run by Genzyme, a Sanofi Company at 14 sites in Italy.
Trial summary
The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Hodgkin Lymphoma
- What is being tested?
- Fludarabine Phosphate (Fludara)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 14 sitesItaly
- Study dates
- Jun 2004to Oct 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Indolent B-cell follicular non-Hodgkin's lymphoma (grade I-II according to REAL classification)
- Stage II to IV according to Ann Arbor staging system
- WHO performance status grade 0, 1 or 2 and life expectancy of greater than 6 months
Who cannot join
- Patients who have received any previous treatment for follicular NHL
- Patients with severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease
- Pregnant and lactating women
- Women of childbearing potential, and all men, not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
- Laboratory screens positive for Hepatitis B, C or HIV infections
- Patients with autoimmune thrombocytopenia or hemolytic anemia with clinical evidence. NB. A positive Coombs test alone (with no clinical evidence of hemolysis) would not preclude entry in the study.
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- Histological transformation to aggressive B-cell lymphoma
- Patients with prior malignancies except non melanoma skin tumors or stage 0 (in situ) cervical carcinoma
- Impairment of hepatic function unless disease related indicated by bilirubin, ASAT, ALAT or gamma-GT raised 2 times above the upper limit of the local laboratory range
- Impairment of renal function indicated by serum creatinine < 30 ml/min
- Patients who require systemic long-term therapy with glucocorticoids
- Participation at the same time in another study in which investigational drugs are used
- Patients unable to regularly attend outpatient clinic for treatment and assessments
- Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent
- Patients with active infection
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
Study site
Bologna, BO, 40138
Study site
Cagliari, 09121
Study site
Cesena, FC, 47023
Study site
Florence, 50139
Study site
Forlì, FC, 47100
Study site
Genova, GE, 16132
Study site
Naples, 80131
Study site
Ravenna, 48100
Study site
Rimini, RN, 47900
Study site
Roma, RM, 00144
Study site
Roma, RM, 00168
Study site
Roma, 00161
Study site
Siena, 53100
Study site
Udine, 33100
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile
Read the detailed description
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
- Conditions
- Non Hodgkin Lymphoma
- Being tested
- Fludarabine Phosphate (Fludara)
- Keywords
- Non Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine Phosphate (Fludara)Drug
Also called BAY86-4864
All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Fludarabine Phosphate (Fludara) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: Measurement of outcome 4 to 6 weeks after EOT
Secondary outcomes (1)
Overall response rate, molecular response rate, toxicity profile, patients quality of life
Measured: Measurement of outcome 4 to 6 weeks after EOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00185445
- Sponsor's protocol ID
- 308580
- Other IDs
- 91381
- Status last verified
- Dec 2013
- First submitted
- 13 Sep 2005
- Last updated
- 4 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of Oral Fludarabine Phosphate in Combination With Mitoxantrone as First Line Treatment in Follicular NHL
- ClinicalTrials.gov ID
- NCT00185445
- Acronym / sponsor ID
- 308580
- Conditions
- Non Hodgkin Lymphoma
- Keywords
- Non Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate that oral fludarabine phosphate is comparable to i.v. formulation used in combination with mitoxantrone in terms of efficacy, safety and risk/benefit profile
Detailed description
As of 29 May 2009, the clinical trial sponsor is Genzyme Corporation. NOTE: This study was originally posted by sponsor Schering AG, Germany, which was subsequently renamed to Bayer Schering Pharma AG, Germany.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Fludarabine Phosphate (Fludara) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indolent B-cell follicular non-Hodgkin's lymphoma (grade I-II according to REAL classification)
- Stage II to IV according to Ann Arbor staging system
- WHO performance status grade 0, 1 or 2 and life expectancy of greater than 6 months
Key exclusion criteria (15 listed)
- Patients who have received any previous treatment for follicular NHL
- Patients with severe or life-threatening cardiac, pulmonary, neurological, psychiatric or metabolic disease
- Pregnant and lactating women
- Women of childbearing potential, and all men, not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
- Laboratory screens positive for Hepatitis B, C or HIV infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fludarabine Phosphate (Fludara)Also: BAY86-4864All patients will receive fludarabine phosphate orally for 3 consecutive days per cycle and mitoxantrone on day 1. Each patient will receive up to six treatment cycles. Treatment cycles will be given at 4 weeks intervals. | Drug | Arm 1 |
Primary outcome
Complete response rate
Time frame: Measurement of outcome 4 to 6 weeks after EOT
1 secondary outcome
Overall response rate, molecular response rate, toxicity profile, patients quality of life
Time frame: Measurement of outcome 4 to 6 weeks after EOT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Genzyme, a Sanofi Company
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine Phosphate (Fludara) in people with Non Hodgkin Lymphoma, run by Genzyme, a Sanofi Company at 14 sites in Italy.
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 3 inclusion and 15 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 4 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete response rate (time frame: Measurement of outcome 4 to 6 weeks after EOT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2013.