Primary endpoints were to confirm the feasibility and efficacy of IEV in poor risk Hodgkin’s lymphoma and aggressive NHLs.
Additional endpoints were to try to evaluate its possible role in the salvage strategy of indolent NHLs, lymphoblastic lymphoma and multiple myeloma. Analysis of toxicity and PBSC mobilization.
Conclusions from the authors: Our study confirms that IEV +/- HDT is a well-tolerated and effective salvage treatment for lymphoid malignancies, and that IEV acts as an excellent stem cell mobiliser.

Official Title

Ifosfamide, epirubicin, etoposide (IEV) and autologous peripheral blood progenitor cell transplant: a feasible and effective salvage treatment for lymphoid malignancies

Conditions

Study Type

Phase II

Study Design

Lymphoid malignancies: Hodgkin’s lymphoma (20), DLBCL (17), MCL (4), lymphoblastic lymphoma (6), follicular lymphoma (7), multiple myeloma (11), second relapse (55), in CR in order to mobilize PBSCs (8), or as first line (2).

Further Details

Treatment: IEVEpirubicin 100 mg/m2 i.v. (30 min inf.) d1Etoposide 150 mg/m2 i.v. (1h inf.) d1-3Ifosfamide 2500 mg/m2 i.v. (1h inf.) d1-3 with mesnaEfficacy:Hodgkin’s lymphoma: 90% CR, 5% PR, 27 mo DFS, 32 mo OSIndolent NHL: 16.5% CR, 16.5% PR, 11 mo DFS, 14 mo OSAggressive NHL: 41% CR, 9% PR, 22 mo DFS, 16 mo OSMultiple myeloma: 30% CR, 20% PR, 7 mo DFS, 12 mo OSSuccessful PBSC mobilization: 95% (37 out of 39)CD34+ cells/kg: 16 x 106 (HL), 12.2 x 106 (NHL), 13.7 x 106 (MM) Tolerability: Well tolerated in most patients.Red blood cell transfusions: 37% of patientsPlatelet transfusions. 30% of patientsNo life-threatening infections

Study Start

Eligibility & Criteria

Histological diagnosis of NHL, HL, LBL, or MM; partially responsive or refractory to prior chemotherapy or in confirmed histological relapse; WHO PS ≤ 3; normal liver and renal function, no evidence of congestive heart failure or respiratory failure.

Total Enrolment

65

Contact Details

Clavio,M.; Garrone,A.; Pierri,I.; Michelis,G.L.; Balocco,M.; Albarello,A.; Varaldo,R.; Canepa,P.; Miglino,M.; Ballerini,F.; Canepa,L.; Gobbi,M.University of Genova, ItalyOncology Reports 14 (2005): 933-940

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