T-Cell LymphomasPhase 2FADNCT00840385
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
A Phase 2 study testing FAD in people with T-Cell Lymphomas and Chemotherapy, run by Fudan University at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- T-Cell Lymphomas, Chemotherapy
- What is being tested?
- FAD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Nov 2007to Nov 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
- Aged 18~75.
- Good performance status, ECOG score≤2. Estimated survival span >3 months
- Previously untreated.
- At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
- Good compliance and inform consenting
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- Fit for the following criteria:
- Absolute neutrophil count (ANC)≥1.5×109/L
- Platelet（PLT）≥80×109/L
- Total bilirubin (TBI) ≤upper normal limit (UNL)
- Serum creatine (Cr) ≤UNL
- Alanine aminotransferase (ALT) and Aspartate transaminase（AST）≤1.5 UNL
Who cannot join
- Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
- Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
- Severe uncontrolled underlying diseases
- Pregnancy or lactation
- Autoimmune disease history
- Severe infection or metabolic diseases
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- Known allergic to multiple agents, including sulphanilamide.
- Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
- Lymphoma involving central nervous system
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xiaojian Liu, PhD, 8613816983809 ext. 1107, Xiaojian_liu068@hotmail.com
About this study
Official title: Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
The primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.
Read the detailed description
Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.
- Conditions
- T-Cell Lymphomas, Chemotherapy
- Being tested
- FAD
- Keywords
- Peripheral T-cell lymphomas (PTCL), Fludarabine
- Medical subject headings
- Lymphoma, T-Cell, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FADDrug
Also called Fludarabine phosphate, oral fludarabine
Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: FAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
side effects
Measured: 1 months
Secondary outcomes (2)
PFS (progression free survival)
Measured: 3 months
complete remission(CR)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startNov 2007
- Primary completionNov 2010 (estimated)
- Study completionNov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T-Cell LymphomasStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Xiaonan Hong, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840385
- Sponsor's protocol ID
- 2007-71-143
- Acronym
- FAD
- Status last verified
- Sep 2010
- First submitted
- 9 Feb 2009
- Last updated
- 15 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
- ClinicalTrials.gov ID
- NCT00840385
- Acronym / sponsor ID
- FAD / 2007-71-143
- Conditions
- T-Cell Lymphomas, Chemotherapy
- Keywords
- Peripheral T-cell lymphomas (PTCL), Fludarabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2010 (estimated)
- First posted
- 10 Feb 2009 (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 primary objective of this study is to evaluate the efficacy of Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with Peripheral T-cell lymphomas (PTCL). 30 patients will be treated into this study.
Detailed description
Doxorubicin is often used to treat Peripheral T-cell lymphomas (PTCL). However, patients with PTCL have an especially poor outcome with a 5-year overall survival rate of only 26% following treatment with standard doxorubicin containing regimens. There is general agreement that results with conventional chemotherapy are so poor in patients with most PTCL that new approaches are warranted.The nucleoside analogs are Fludarabine being combined with other agents in PTCL (excluding ALK positive ALCL and primary cutaneous ALCL) is reported by others.We conduct a II stage clinical trials to evaluate the efficacy of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) as first line therapy in patients with in Newly Diagnosed PTCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FAD |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The diagnosis of peripheral T cell lymphoma must established by histological biopsy, and immunochemistry analysis and cytogenetic assessment should be done as well. The patients with peripheral T cell lymphoma (PTCL), PTCL-unspecified type(PTCL-u), angioimmunoblastic lymphoma (AILT) and non-skin type anaplastic large cell lymphoma (ALCL, ALK-).
- Aged 18~75.
- Good performance status, ECOG score≤2. Estimated survival span >3 months
- Previously untreated.
- At least 1 assessable disease (maximal diameter >1.0cm, the disease foci located within the irradiated area are excluded) evaluated by CT or MRI, PET is also permitted.
Key exclusion criteria (9 listed)
- Severe cardiac, renal or hepatic incompetence: serum direct bilirubin, indirect bilirubin, ALT, AST and Cr greater than 1.5 UNL; cardiac function greater than grade II. 28 days within the major surgical operation.
- Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded)
- Severe uncontrolled underlying diseases
- Pregnancy or lactation
- Autoimmune disease history
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 |
|---|---|---|
| FADAlso: Fludarabine phosphate, oral fludarabineFludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5. | Drug | A |
Primary outcome
side effects
Time frame: 1 months
2 secondary outcomes
PFS (progression free survival)
Time frame: 3 months
complete remission(CR)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2010.
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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.
Xiaonan Hong, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FAD in people with T-Cell Lymphomas and Chemotherapy, run by Fudan University at 1 site in China.
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 12 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: status not confirmed, as of the sponsor's last update on 15 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaojian Liu, PhD (8613816983809, xiaojian_liu068@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
side effects (time frame: 1 months). 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 15 Sep 2010.