Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The prognosis of PTCL (except early stage ALK+ ALCL) is dismal. Previous study showed that single agent lenalidomide showed promising therapeutic activity in patients with relapsed or refractory PTCL. The investigators therefore design this phase II study to investigate the safety and efficacy of lenalidomide in combination with CHOP in patients with treatment-naive PTCL.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide+CHOP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| maximum tolerated dose and dose limited toxicity | At the end of the first cycle of lenalidomide+CHOP (each cycle is 21 days) | |
| Overall response rate | overall response rate after treated by lenalidomide-CHOP regimen | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival | from date of inclusion to date of progression, relapse, or death from any cause | 2 years |
| Overall survival | from the date of inclusion to date of death, irrespective of cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Wang, M.D., Ph.D. | Contact | 86 25 68306034 | lilyw7878@163.com | |
| Wei Xu, M.D., Ph.D. | Contact | 86 25 68306034 | xuwei10000@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wei Xu, M.D., Ph.D. | The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first Affiliated Hospital Of Nanjing Medical University(JiangSu Province Hospital) | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24441915 | Background | Hopfinger G, Nosslinger T, Lang A, Linkesch W, Melchardt T, Weiss L, Egle A, Greil R. Lenalidomide in combination with vorinostat and dexamethasone for the treatment of relapsed/refractory peripheral T cell lymphoma (PTCL): report of a phase I/II trial. Ann Hematol. 2014 Mar;93(3):459-62. doi: 10.1007/s00277-014-2009-0. Epub 2014 Jan 18. | |
| 23731832 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D046248 | Pyloric Stenosis, Hypertrophic |
| ID | Term |
|---|---|
| D011707 | Pyloric Stenosis |
| D017219 | Gastric Outlet Obstruction |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide |
| Drug |
Cyclophosphamide 750 mg/m2 d1 |
|
| Doxorubicin | Drug | Doxorubicin 50 mg/m2 d1 |
|
| Vincristine | Drug | Vincristine 1.4mg/m2 (maximum 2mg) d1 |
|
| Prednisolone | Drug | Prednisolone 60mg/m2 d1-5 |
|
| 2 years |
| Morschhauser F, Fitoussi O, Haioun C, Thieblemont C, Quach H, Delarue R, Glaisner S, Gabarre J, Bosly A, Lister J, Li J, Coiffier B. A phase 2, multicentre, single-arm, open-label study to evaluate the safety and efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial. Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 May 31. |
| 24632715 | Background | Iqbal J, Wright G, Wang C, Rosenwald A, Gascoyne RD, Weisenburger DD, Greiner TC, Smith L, Guo S, Wilcox RA, Teh BT, Lim ST, Tan SY, Rimsza LM, Jaffe ES, Campo E, Martinez A, Delabie J, Braziel RM, Cook JR, Tubbs RR, Ott G, Geissinger E, Gaulard P, Piccaluga PP, Pileri SA, Au WY, Nakamura S, Seto M, Berger F, de Leval L, Connors JM, Armitage J, Vose J, Chan WC, Staudt LM; Lymphoma Leukemia Molecular Profiling Project and the International Peripheral T-cell Lymphoma Project. Gene expression signatures delineate biological and prognostic subgroups in peripheral T-cell lymphoma. Blood. 2014 May 8;123(19):2915-23. doi: 10.1182/blood-2013-11-536359. Epub 2014 Mar 14. |
| 27982416 | Background | Schmitz N, de Leval L. How I manage peripheral T-cell lymphoma, not otherwise specified and angioimmunoblastic T-cell lymphoma: current practice and a glimpse into the future. Br J Haematol. 2017 Mar;176(6):851-866. doi: 10.1111/bjh.14473. Epub 2016 Dec 16. |
| D004066 |
| Digestive System Diseases |
| D009930 |
| Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |