A Phase II Study of IGEV +/- Bortezomib Before Hign Dose Consolidation in Relapsed/Refractory Hodgkin's Lymphoma

Hodgkin Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636311
• Other study ID #: ONC-2006-005
• Secondary ID: EUDRACT 2007-004
• Status: Completed
• Phase: Phase 2
• First received: March 11, 2008
• Last updated: September 1, 2010
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: September 2010
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2010
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease

Intervention

Drug:
• Ifosfamide, Gemcitabine, Vinorelbine
Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.
• Bortezomib + IGEV
Bortezomib 1,3 mg/sqm, day 1, 4, 8; Ifosfamide 2000 mg/sqm, day 1-4 (plus MESNA); Gemcitabine 800 mg/sqm, day 1 and 4; Vinorelbine 20 mg/sqm, day 1; Prednisone 100 mg, day 1-4; G-CSF 1 vial sc, day 7-12 of each 21-day course.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET negativity rate obtained with IGEV or B-IGEV will be compared		PET negativity after 4 courses of induction (IGEV or B-IGEV)	Yes