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

NCT00636311 | Completed Phase 2

• 2 other identifiers: ONC-2006-005EUDRACT 2007-004883-29
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Keywords

Hodgkin disease; Salvage therapy; Bortezomib; Transplantation

Outcome Measures

Primary Outcomes (1)

• PET negativity rate obtained with IGEV or B-IGEV will be compared

  PET negativity after 4 courses of induction (IGEV or B-IGEV)

Study Arms (2)

1

ACTIVE COMPARATOR

IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)

Drug: Ifosfamide, Gemcitabine, Vinorelbine

2

EXPERIMENTAL

B-IGEV (Bortezomib + IGEV)

Drug: Bortezomib + IGEV

Interventions

Ifosfamide, Gemcitabine, Vinorelbine 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.

1

Bortezomib + IGEV 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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

Location

Related 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. doi: 10.3324/haematol.10661.

  PMID: 17229633 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease

Interventions

Ifosfamide; Gemcitabine; Vinorelbine; Bortezomib

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Boronic Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Boron Compounds; Pyrazines

Study Officials

• Armando Santoro, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 11, 2008
• First Posted: March 14, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: February 1, 2010
• Last Updated: September 2, 2010

Record last verified: 2010-09

Locations

IT (1)