R-GIFOX for Relapsed and Refractory Aggressive Non-Hodgkin’s Lymphoma

Aim: To evaluate the clinical activity, toxicity and mobilizing capacity of a new short-course (bi-weekly), dose intensive, cytoreductive/mobilizing salvage regimen (R-GIFOX) combining the cross-synergistic agents Gemcitabine (G), Ifosfamide (Ifo), Oxaliplatin (Ox) and Rituximab (R) in patients with relapsed and refractory CD20+ NHL.

Conclusions:
R-GIFOX was feasible, tolerable, effective and able to mobilize peripheral stem cells in patients with reccurrent aggressive NHL. It enabled the achievement of effective dose-intensities and high response rates also in the older patients.

Official Title

Gemcitabine, Ifosfamide, Oxaliplatin and Rituximab (R-GIFOX), a New Effective Cytoreductive/Mobilizing Salvage Regimen for Relapsed and Refractory Aggressive Non-Hodgkin’s Lymphoma: Results of a Pilot Study

Conditions

Study Type

Pilot Phase II

Study Design

Patients: 14 patients (median age 63 years, range 37-78 years) with relapsed (n = 9) or primary progressive (n = 5) aggressive [diffuse large cell (n=7), mantle cell (n=4), follicular G3b (n=3)] advanced (stage IV = 71%), poor risk (IPI 3-5 = 50% median number of previous therapy=2, r 1-4) NHLTreatment:R-GIFOX consisted of R (375 mg/m2, d 1), G (1000 mg/m2, d 2), Ox (130 mg/m2, d 3) and Ifosfamide (5 g/m2, d 3), as a 24-hour single infusion in patients aged ≤ 65 years, or fractionated over 3 days (dd 3-5) in older patients.Treatment was given every two weeks with G-CSF support (5 mcg/kg/day, dd 6-11; 10 mcg/kg/day at the 3rd course) for stem cells mobilization. It was planned to give three courses of therapy followed by mobilization and ASCT or three more courses if ineligible for ASCT.

Further Details

Results:Responses evaluated after 3 cycles by the integrated FDG-PET/IWC criteria, and reassessed at the end of the entire program. The ORR assessed after three courses of R-GIFOX was 77%, 7 complete responses (54%; CR=5; CRu=2) & 3 partial; CRu converted to CR at BM biopsy after 6 courses. According to age, the ORR was 67% (4 CR, 2 PR) and 80% (3 CR, 1 PR) for patients aged ≤ 65 years and those older, respectively. According to disease status, the ORR was 40% (1 CR, 1 PR) and 89% (6 CR, 2 PR) for primary refractory and relapsed patients, respectively. Among CRs no patient has relapsed at a median time of 5 months (range, 2+ – 10+). CTCAE v3.0 G3/G4 thrombocytopenia was present in 26 % of courses G3/G4 neutropenia in 22%; febrile neutropenia and infections in 8% and 6% of cycles, respectively.

Study Start

Eligibility & Criteria

Indication: Non Hodgkin’s Lymphoma

Total Enrolment

Contact Details

Gaetano Corazzelli et alAbstract 940 ASH 2005Hematology Oncology Unit, INT, IRCCS, Naples, Italy