Clinical trial NCT00636311: A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma
Official title: IGEV +/- Bortezomib (Velcade) as Induction Before High Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma After First Line Treatment: a Randomized Phase II Trial. On Behalf of Intergruppo Italiano Linfomi
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hodgkin Disease
Keywords: Hodgkin disease
Salvage therapy
Bortezomib
Transplantation
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2008-03-14
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate if the addition of Bortezomib (Velcade) to IGEV combination (Ifosfamide, Gemcitabine and Vinorelbine) in patients with relapsed/refractory Hodgkin's lymphoma increases the rate of complete remission (PET negativity) at transplantation.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hodgkin's lymphoma failing or relapsing after first-line chemotherapy (MOPP/AVBD , MOPP/EBV/CAD and analogs are considered one line)
* Age \>18 and \<65 years
* Signed informed consent
* If female, patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control
* If male, patient agrees to use an acceptable barrier method for contraception
* ECOG performance status \<2
* Platelet count \>100.000/mmc
* Hemoglobin \>7.5 g/dL
* Absolute neutrophil count (ANC) \>1.500/mmc
* Serum calcium \<3.5 mmol/L (\<14 mg/dL)
* AST/ALT: \<2.5 x the ULN
* Total bilirubin: \<1.5 x the ULN

Exclusion Criteria:

* Previous treatment with velcade
* Nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment
* Immunotherapy or antibody therapy within 4 weeks before enrollment
* Experimental drug or medical device within 4 weeks before start of treatment
* Major surgery within 4 weeks before enrollment
* History of allergic reaction attributable to compounds containing boron or mannitol or any of the drugs in the IGEV regimen
* Peripheral neuropathy of NCI CTCAE Grade 2 or higher
* Myocardial infarction within 6 months of enrollment or NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
* History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances including diabetes mellitus
* Need for therapy with concomitant CYP 3A4 inhibitors or inducers
* HIV-positive, if known
* Hepatitis B surface antigen-positive or active hepatitis C infection, if known
* Active systemic infection requiring treatment
* If female, pregnancy or breast-feeding.

Primary outcomes:
measure: PET negativity rate obtained with IGEV or B-IGEV will be compared
timeFrame: PET negativity after 4 courses of induction (IGEV or B-IGEV)
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
Study officials:
affiliation: Istituto Clinico Humanitas
name: Armando Santoro, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Santoro A, Magagnoli M, Spina M, Pinotti G, Siracusano L, Michieli M, Nozza A, Sarina B, Morenghi E, Castagna L, Tirelli U, Balzarotti M. Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma. Haematologica. 2007 Jan;92(1):35-41. doi: 10.3324/haematol.10661.