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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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Hodgkin Disease

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Armando Santoro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Istituto Clinico Humanitas

Authority:

Italy: Ministry of Health

Study ID:

ONC-2006-005

NCT ID:

NCT00636311

Start Date:

February 2008

Completion Date:

February 2010

Related Keywords:

  • Hodgkin Disease
  • Hodgkin disease
  • Salvage therapy
  • Bortezomib
  • Transplantation
  • Hodgkin Disease
  • Lymphoma

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