Clinical trial · Interventional
Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed Peripheral T-cell Lymphomas (PTCL)
Phase II Study of Orally Fludarabine, Adriamycin and Dexamethasone (FAD) in Newly Diagnosed PTCL
NCT00840385CI-TRIAL-00003915FADunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy | — | UNRESOLVED | — |
| T-Cell Lymphomas | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FAD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: FAD
Primary outcomes (1)
- measure
- side effects
- timeFrame
- 1 months
Secondary outcomes (2)
- measure
- PFS (progression free survival)
- timeFrame
- 3 months
- measure
- complete remission(CR)
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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-). 2. Aged 18\~75. 3. Good performance status, ECOG score≤2. Estimated survival span \>3 months 4. Previously untreated. 5. 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. 6. Good compliance and inform consenting 7. 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: 1. 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. 2. Other malignancy history (skin basement cell carcinoma and cervical carcinoma are excluded) 3. Severe uncontrolled underlying diseases 4. Pregnancy or lactation 5. Autoimmune disease history 6. Severe infection or metabolic diseases 7. Known allergic to multiple agents, including sulphanilamide. 8. Severe peptic ulceration or bleeding, contra-indicative for corticosteroids 9. Lymphoma involving central nervous system
References
Publications (0)
Data not yet available
No reference posted for this study.