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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00636311

Enrollment

Registered

2008-03-14

Start date

2008-02-29

Completion date

2010-02-28

Last updated

2010-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin Disease

Keywords

Hodgkin disease, Salvage therapy, Bortezomib, Transplantation

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.

Interventions

DRUGIfosfamide, 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.

DRUGBortezomib + 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
PET negativity rate obtained with IGEV or B-IGEV will be compared	PET negativity after 4 courses of induction (IGEV or B-IGEV)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026