A Phase II Study of OXALIPLATIN and GEMCITABINE in Combination with IFOSFAMIDE plus RITUXIMAB (R-GIFOX) as 2nd-line Chemotherapy in Relapsed and Primary Refractory Lymphoma - R-GIFOX
- Conditions
- Patients with Relapsed and Primary Refractory LymphomaMedDRA version: 9.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cell
- Registration Number
- EUCTR2006-003243-23-IT
- Lead Sponsor
- ISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
4.1.1Patients must have histologically confirmed diagnosis of lymphoma of the following subtypes according to REAL/WHO ,
Non-Hodgkin's lymphomas
?Diffuse Large B Cell Lymphoma (DLBCL) and variants
?Anaplastic Large Cell Lymphoma (ALCL) B/null
?Mantle Cell Lymphoma (MCL)
?Follicular Cell Lymphoma (FCL) Grade 3
?Histologic Transformation of previous indolent lymphomas
Hodgkin's disease
?Classic Hodgkin's Lymphoma including lymphocyte rich category
4.1.2Patient must be relapsing to or primary progressive while on 1st-line induction anthracycline-containing chemotherapy with and without immunotherapy (Rituximab) and/or radiotherapy
4.1.3Patients must have measurable disease, defined according criteria detailed in Section 12.
4.1.4Age >18 years
4.1.5Life expectancy of greater than 3 months.
4.1.6ECOG performance status <2; see Appendix A.
4.1.7Patients must have normal organ and marrow function as defined below:
-Absolute neutrophil count>1,500/mL
-Platelets>100,000/mL
-Total bilirubinwithin normal institutional limits
-AST (SGOT)/ALT (SGPT)<2.5 X institutional upper limit of normal
-creatininewithin normal institutional limits or Creatinine clearance >60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal, as calculated by using the Cockcroft-Gault formula:
(140 ? Age) x Weight (kg) x [1-(0.15 x Sex)]
0.814 x Serum Creatinine (mg/dL)
Sex: Male=0; Female=1
4.1.8Ability to understand and the willingness to sign a written informed consent document including consent for ASCT in patients aged <=.65 years.
4.1.9The effects of Oxaliplatin and Gemcitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because Cisplatin analogs agents as well as other therapeutic agents used in this trial (i.e. and Ifosfamide) are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
4.2.1Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
4.2.2Patients may not be receiving any other investigational agents.
4.2.3Patients with known lymphoma brain localization should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events.
4.2.4History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in the study.
4.2.5Uncontrolled intercurrent illness including, but not limited to, ongoing active infection (including hepatitis B), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrollable metabolic disease, or psychiatric illness/social situations that would limit compliance with study requirements.
4.2.6Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects of agents employed.
4.2.7Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients are excluded.
4.2.8More than one month between staging procedures and the start of the treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method