Clinical trial · Interventional
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
NCT00636311CI-TRIAL-00003863completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib + IGEV | Drug | — | UNRESOLVED |
| Ifosfamide, Gemcitabine, Vinorelbine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- IGEV regimen (Ifosfamide, Gemcitabine, Vinorelbine)
- interventionNames
- Drug: Ifosfamide, Gemcitabine, Vinorelbine
- type
- EXPERIMENTAL
- label
- 2
- description
- B-IGEV (Bortezomib + IGEV)
- interventionNames
- Drug: Bortezomib + IGEV
Primary outcomes (1)
- measure
- PET negativity rate obtained with IGEV or B-IGEV will be compared
- timeFrame
- PET negativity after 4 courses of induction (IGEV or B-IGEV)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (1)
- BACKGROUNDSantoro 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