Aim: To analyse the treatment outcome of IMVP-16/Pd (ifosfamide, methotrexate, etoposide and prednisone) followed by high-dose chemotherapy and autologous stem cell transplantation (HDC/ASCT) for patients with peripheral T-cell lymphomas (PTCLs) who were previously treated with CHOP.

Conclusions: These results indicate that IMVP-16/Pd followed by HDC/ASCT appears to be an effective salvage regimen, especially for NK/T-cell lymphoma.

Official Title

IMVP-16/Pd followed by high-dose chemotherapy and autologous stem cell transplantation as a salvage therapy for refractory or relapsed peripheral T-cell lymphomas

Conditions

Study Type

Phase II

Study Design

Treatment:IMVP-16 / PdIfosfamide 1000 mg/m2 i.v. d1-5 with mesnaEtoposide 100 mg7m2 i.v. d1-3Methotrexate 30 mg/m2 i.v. d3+10Prednisone 100 mg p.o. d1-5To be repeated every 3 weeks (3 cycles)HDC / ASCT (for patients who showed a CR / PR to IMVP-16 / Pd)Mobilization / Collection of peripheral blood stem cells usingCyclophosphamide 4000 mg/m2 i.v. d1G-CSF 5ug/kg s.c.Conditioning regimen: BEAM (BCNU / etoposide / cytarabine / melphalan)Autologous stem cell infusion.

Further Details

Efficacy:CR: 5 (3 of 4 natural killer / T-cell lymphoma, 1 of 6 non-NK/t-cell lmyphoma)PR: 4OR: 28.1%HD ( ASCT: 6 / 9 patients)3-y PFS: 12.2%3-y OS: 14.2%Tolerability:WHO 3/4 adverse effects (n / % of patients):Neutropenia 19 / 59.4%Febrile neutropenia: 8 / 25.0%Anemia: 6 / 18.8%Thrombocytopenia: 6 / 18.8%Infection: 5 / 15.6%Hepatotoxicity: 1 / 3.1%Diarrhea: 1 / 3.1%

Study Start

Eligibility & Criteria

Indication: Refractory or relapsed peripheral T-cell lymphomas (PCTLs)Eligibility: Failure to respond to or relapse after first-line induction treatment with CHOP. Cutaneous T-cell lymphoma, lymphoblastic and adult T-cell leukemia/lymphoma were excluded.

Total Enrolment

32 (10 relapsed, 22 refractory)

Contact Details

Park,B.B.; Kim,W.S.; Lee,J.; Park,K.W.; Kang,J.H.; Lee,S.H.; Park,J.O.; Kim,K.; Jung,C.W.; Park,Y.S.; Im,Y.H.; Kang,W.K.; Ko,Y.H.; Lee,M.H.; Park,K.Institution: Sungkyunkwan University School of Medicine, Seoul, KoreaLeukemia & Lymphoma 46 (2005): 1743-1748

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