LymphomaPhase 2NCT00688883
Fludara (Oral) Phase II Study for Indolent Lymphoma
A Phase 2 study testing Fludarabine Phosphate (Fludara) in people with Lymphoma, run by Genzyme, a Sanofi Company at 17 sites in Japan.
Trial summary
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- 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
- 52 participants
- Where
- 17 sitesJapan
- Study dates
- Feb 2003to Aug 2004
- 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 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
- Patients with measurable lesions (major axis > 1.5 cm by CT)
- Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
- Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
- Patients who have PS Grade 0 to 2 in the criteria of ECOG
- Patients with adequately maintained organ functions
Who cannot join
- Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
- Patients who are positive for HBs antigen, HCV antibody or HIV antibody
- Patients who received G-CSF or blood transfusion within 1 week before the screening test
- Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
- Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Japan17 sites
Study site
Akashi-shi, Hyōgo, 673-8558
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Fukuoka, Fukuoka, 812-0033
Study site
Fukuoka, Fukuoka, 812-8582
Study site
Hamamatsu, Shizuoka, 431-3192
Study site
Isehara-shi, Kanagawa, 259-1193
Study site
Kagoshima, Kagoshima-ken, 890-0064
Study site
Kashiwa-shi, Chiba, 277-8577
Study site
Kyoto, Kyoto, 602-0841
Study site
Moriguchi-shi, Osaka, 570-8540
Study site
Nagasaki, Nagasaki, 852-8523
Study site
Nagoya, Aichi-ken, 464-8681
Study site
Nagoya, Aichi-ken, 466-8560
Study site
Okayama, Okayama-ken, 700-8558
Study site
Sapporo, Hokkaido, 003-0006
Study site
Sendai, Miyagi, 980-0872
Study site
Shinjuku-ku, Tokyo, 160-8582
About this study
Official title: A Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
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
- Lymphoma
- Being tested
- Fludarabine Phosphate (Fludara)
- Keywords
- Fludarabine, Purine analog, Indolent lymphoma
- Medical subject headings
- Lymphoma
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
Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given.
| 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.
Best overall response rate; Antitumor effect
Measured: at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle
Secondary outcomes (4)
CR rate
Measured: after last observation of last treatment cycle
Time to treatment failure
Measured: after last observation of last treatment cycle
Overall survival
Measured: after last observation of last treatment cycle
Adverse events collection
Measured: after last observation of last treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2008 (estimated)
- Study startFeb 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 52 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
- NCT00688883
- Sponsor's protocol ID
- 305621
- Other IDs
- 91101
- Status last verified
- Dec 2013
- First submitted
- 30 May 2008
- Last updated
- 4 Dec 2013
- Results posted
- 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 Multicenter, Open Study to Assess the Antitumor Effect and Safety of Oral Fludarabine Phosphate (Fludara (SH T 586): 40 mg/m2/Day) Administered in 3 - 6 Treatment Cycles (1 Treatment Cycle: 5-consecutive Day Dosing, Followed by a Observation Period of 23 Days) in Patients With Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00688883
- Acronym / sponsor ID
- 305621
- Conditions
- Lymphoma
- Keywords
- Fludarabine, Purine analog, Indolent lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 3 Jun 2008 (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.
To assess the antitumor effect and safety of Fludara in patients with indolent lymphoma.
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
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with histologically or cytologically confirmed indolent lymphoma (including mantle cell lymphoma)
- Patients with measurable lesions (major axis > 1.5 cm by CT)
- Patients who failed to have PR to previous chemotherapies or antibody therapies. Patients with subsequent relapse after a previously attained CR or with subsequent recurrence after a previously attained PR
- Patients who have not received chemotherapies, antibody therapies or radiotherapies for more than 4 weeks (more than 3 months in the case of the antibody therapies)
- Patients who have PS Grade 0 to 2 in the criteria of ECOG
Key exclusion criteria (5 listed)
- Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency (DIC), CNS metastases, fever more than 38 degrees Celsius, interstitial pneumonia or pulmonary fibrosis, active other malignancies, AIHA or the history of allergies to similar purine analogs
- Patients who are positive for HBs antigen, HCV antibody or HIV antibody
- Patients who received G-CSF or blood transfusion within 1 week before the screening test
- Patients who had ever received previous therapy with fludarabine phosphate injection (Fludara), pentostatin (Coforin), cladribine (Leustatin) or SH T 586
- Patients who are pregnant, of childbearing potential, lactating, or who do not agree to practice contraception
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: BAY86-4864Patients received Fludarabine Phosphate orally for 5 consecutive days, followed by a 23-day observation period. Setting this as 1 treatment cycle, 6 cycles will be given. | Drug | Arm 1 |
Primary outcome
Best overall response rate; Antitumor effect
Time frame: at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle
4 secondary outcomes
CR rate
Time frame: after last observation of last treatment cycle
Time to treatment failure
Time frame: after last observation of last treatment cycle
Overall survival
Time frame: after last observation of last treatment cycle
Adverse events collection
Time frame: after last observation of last treatment cycle
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
17 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 Lymphoma, run by Genzyme, a Sanofi Company at 17 sites in Japan.
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 6 inclusion and 5 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 17 sites in Japan. 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?
Best overall response rate; Antitumor effect (time frame: at screening and re-evaluation, at 4th week or at the time of discontinuation of treatment cycles 1, 3 and 6, and at 12th week after last observation of last treatment cycle). 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; AzTrials last refreshed its copy on 6 Nov 2026.