Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Fudan University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Fudan University
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00840385
First received: February 9, 2009
Last updated: September 14, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
T-Cell Lymphomas Chemotherapy |
Drug: FAD |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Dexamethasone sodium phosphate
Fludarabine
Doxorubicin
Doxorubicin hydrochloride
Fludarabine phosphate
U.S. FDA Resources
Further study details as provided by Fudan University:
Primary Outcome Measures:
- side effects [ Time Frame: 1 months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PFS (progression free survival) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- complete remission(CR) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: FAD
Fludarabine 40mg/m2 po.d1-3; Adriamycin 50mg/m2 i.v.d1; Dexamethasone 20mg/d po.d1-5.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
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
Exclusion Criteria:
- 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
- Known allergic to multiple agents, including sulphanilamide.
- Severe peptic ulceration or bleeding, contra-indicative for corticosteroids
- Lymphoma involving central nervous system
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00840385
Contacts
| Contact: Xiaojian Liu, PhD | 8613816983809 | xiaojian_liu068@hotmail.com |
Locations
| China, Shanghai | |
| Cancer Hospital, Fudan University | Recruiting |
| Shanghai, Shanghai, China, 200032 | |
| Contact: Xiaojian Liu, PhD 8613816983809 ext 1107 Xiaojian_liu068@hotmail.com | |
Sponsors and Collaborators
Fudan University
Investigators
| Principal Investigator: | Xiaonan Hong, MD | Fudan University |
More Information
No publications provided
| Responsible Party: | Base for drug clinical trials, Fudan University cancer hospital, Fudan University cancer hospital |
| ClinicalTrials.gov Identifier: | NCT00840385 History of Changes |
| Other Study ID Numbers: | 2007-71-143 |
| Study First Received: | February 9, 2009 |
| Last Updated: | September 14, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Fudan University:
|
Peripheral T-cell lymphomas (PTCL) Fludarabine |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Fludarabine Fludarabine monophosphate |
Doxorubicin BB 1101 Vidarabine Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
ClinicalTrials.gov processed this record on May 21, 2013