Study of Bortezomib (Velcade) in Combination With Dexamethasone to Treat Patients With Relapsed Hodgkin's Lymphoma

A Phase II Study of Bortezomib in Combination With Dexamethasone in Patients With Relapsed Hodgkin's Lymphoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00148018

Enrollment

Registered

2005-09-07

Start date

2005-03-31

Completion date

Unknown

Last updated

2008-07-10

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, Bortezomib, Relapse, Lymphoma

Brief summary

The primary objective of this study is to evaluate wether bortezomib and dexamethasone are active in patients with relapsed Hodgkin's lymphoma.

Detailed description

The proteasome-inhibitor bortezomib (Velcade) shows promising activity in various human lymphoma cell line. In addition, several studies in heavily pretreated patients with lymphoma showed also promising results.

Interventions

DRUGBortezomib

DRUGDexamethasone

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Hodgkin's lymphoma * Second or higher relapse (first relapse if high-dose chemotherapy not possible) * Age \>/= 18 years * No major organ dysfunction or intercurrent disorder * Written informed consent

Exclusion criteria

* Pregnant or nursing

Design outcomes

Primary

Measure	Time frame
Overall response rate (complete and partial responses)	—

Secondary

Measure	Time frame
Toxicity	—
Event free survival	—
Overall survival	—
Duration of response	—
Treatment administration (dose-intensity, total dose)	—

Countries

Germany

Outcome results

None listed

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