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

NCT ID: NCT00636311

Last Updated: 2010-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-02-28

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.

Conditions

Hodgkin Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)

Group Type: ACTIVE_COMPARATOR

Ifosfamide, Gemcitabine, Vinorelbine

Intervention Type: DRUG

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.

2

B-IGEV (Bortezomib + IGEV)

Group Type: EXPERIMENTAL

Bortezomib + IGEV

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Istituto Clinico Humanitas

Principal Investigators

Armando Santoro, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 17229633 (View on PubMed)

Other Identifiers

EUDRACT 2007-004883-29

Identifier Type: -

Identifier Source: secondary_id

ONC-2006-005

Identifier Type: -

Identifier Source: org_study_id