Lymphoma, Low-GradePhase 2NCT00311129
Efficacy and Safety Study of SH T 586 in Combination With Rituximab to Treat Low-Grade NHL
A Phase 2 study testing Fludarabine Phosphate (Fludara) and Rituximab in people with Lymphoma, Low-Grade, run by Genzyme, a Sanofi Company at 8 sites in Japan.
Trial summary
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient with indolent lymphoma. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Lymphoma, Low-Grade
- What is being tested?
- Fludarabine Phosphate (Fludara) and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesJapan
- Study dates
- Dec 2005to Jul 2007
- 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 CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
- Patients with measurable lesions (> 1.5 cm).
- Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
- ECOG performance status: 0 - 1
- Patients with adequately maintained organ functions.
Who cannot join
- Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever </=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
- Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
- Patients who received G-CSF or transfusion within 1 week before the registration.
- Patients with the history of allergies to purine nucleoside analogue.
- Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
- Patients who had ever received prior therapy with fludarabine phosphate injection, pentostatin, cladribine, SH T 586, blood stem cell transplant, or monoclonal antibody therapy other than rituximab to NHL (including radioimmunotherapy).
Show all 9Show fewer
- Patients who had progressive disease within 6 months of receiving therapy including rituximab.
- Women who are pregnant, of childbearing potential, or lactating.
- Patients who do not agree to practice contraception.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Study site
Chuo-ku, Tokyo, 104-0045
Study site
Hamamatsu, Shizuoka, 431-3192
Study site
Isehara-shi, Kanagawa, 259-1193
Study site
Kashiwa-shi, Chiba, 277-8577
Study site
Kyoto, Kyoto, 602-0841
Study site
Nagoya, Aichi-ken, 464-8681
Study site
Nagoya, Aichi-ken, 466-0814
Study site
Sendai, Miyagi, 980-0872
About this study
Official title: A Multicenter Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
The purpose of this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient 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, Low-Grade
- Being tested
- Fludarabine Phosphate (Fludara), Rituximab
- 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
Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
RituximabDrug
Injection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD)
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Fludarabine Phosphate (Fludara) |
| Arm 2 | Active comparator | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: The best response until the end of 6th treatment cycle
Secondary outcomes (3)
CR rate
Measured: CR or CRu until the end of 6th treatment cycles
Progression free survival
Measured: Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Overall survival
Measured: Death, observed until 12 weeks after the completion of the treatment in the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Low-GradeStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Genzyme, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311129
- Sponsor's protocol ID
- 309123
- Other IDs
- 91456
- Status last verified
- Dec 2013
- First submitted
- 31 Mar 2006
- Last updated
- 4 Dec 2013
- Results posted
- No
Publications
Tobinai K, Ishizawa K, Ogura M, Itoh K, Morishima Y, Ando K, Taniwaki M, Watanabe T, Yamamoto J, Uchida T, Nakata M, Terauchi T, Nawano S, Matsusako M, Hayashi M, Hotta T. Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma. Cancer Sci. 2009 Oct;100(10):1951-6. doi: 10.1111/j.1349-7006.2009.01247.x. Epub 2009 Jun 17.
PubMed 19594547
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 Study to Assess the Antitumor Effect and Safety of Fludarabine Phosphate Tablet (SH T 586) in Combination With Rituximab Administered in 6 Treatment Cycles (1 Treatment Cycle: Rituximab 375 mg/m2 iv on Day 1 Along With 5-Consecutive Day Oral Dosing of SH T 586 40 mg/m2/Day From Day 1 to Day 5, Followed by an Observation Period of 23 Days) in Patients With Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00311129
- Acronym / sponsor ID
- 309123
- Conditions
- Lymphoma, Low-Grade
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 Apr 2006 (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 this study is to assess the antitumor effect and safety of fludarabine phosphate tablet in combination with rituximab in patient 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Fludarabine Phosphate (Fludara) |
| Arm 2 | Active comparator | Drug: Rituximab |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with CD 20 positive, relapsed/refractory indolent lymphoma. (Regimens of prior chemotherapy are limited to 2; prior rituximab treatments up to 16 times are allowed.)
- Patients with measurable lesions (> 1.5 cm).
- Patients who have not received any treatment for more than 4 weeks after completing previous therapies (6 months in the case of antibody therapies).
- ECOG performance status: 0 - 1
- Patients with adequately maintained organ functions.
Key exclusion criteria (9 listed)
- Patients with infectious disease, serious complications, serious gastrointestinal symptoms, serious bleeding tendency, serious CNS symptoms, fever </=38 °C, interstitial pneumonia or pulmonary fibrosis, active other malignancies, autoimmune hemolytic anemia or the history of the disease, or glaucoma.
- Patients who are positive for HBs antigen, HCV antibody, or HIV antibody.
- Patients who received G-CSF or transfusion within 1 week before the registration.
- Patients with the history of allergies to purine nucleoside analogue.
- Patients who experienced serious hypersensitivity or anaphylaxis to rituximab or mouse protein-derived products.
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: BAY86-4864Injection of rituximab on Day 1 along with 5-consecutive day oral dosing of fludarabine phosphate from Day 1 to Day 5, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD) | Drug | Arm 1 |
| RituximabInjection of rituximab on Day 1, followed by an observation period from Day 6 to Day 28 as 1 treatment cycle, 6 cycles will be given. As for patients who has been observed with partial response (PR) or better antitumor effect, any treatment shall not be provided in principle until the status comes to progressive disease (PD) | Drug | Arm 2 |
Primary outcome
Overall response rate
Time frame: The best response until the end of 6th treatment cycle
3 secondary outcomes
CR rate
Time frame: CR or CRu until the end of 6th treatment cycles
Progression free survival
Time frame: Progression or death which comes earlier, observed until 12 weeks after the completion of the treatment in the last patient
Overall survival
Time frame: Death, observed until 12 weeks after the completion of the treatment in the last patient
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.
- Derived from this study: PubMed 19594547Tobinai K, Ishizawa K, Ogura M, Itoh K, Morishima Y, Ando K, Taniwaki M, Watanabe T, Yamamoto J, Uchida T, Nakata M, Terauchi T, Nawano S, Matsusako M, Hayashi M, Hotta T. Phase II study of oral fludarabine in combination with rituximab for relapsed indolent B-cell non-Hodgkin lymphoma. Cancer Sci. 2009 Oct;100(10):1951-6. doi: 10.1111/j.1349-7006.2009.01247.x. Epub 2009 Jun 17.
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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
8 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) and Rituximab in people with Lymphoma, Low-Grade, run by Genzyme, a Sanofi Company at 8 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 5 inclusion and 9 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 8 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?
Overall response rate (time frame: The best response until the end of 6th treatment cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311129, which also lists 1 linked publication.
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.