NCT00373646

Brief Summary

The purpose of this study is to evaluate Thalidomide for treatment of disseminated MALT Lymphoma or at relapse following helicobacter pylori (HP) - eradication or chemotherapy or radiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

June 18, 2009

Status Verified

June 1, 2009

Enrollment Period

2.6 years

First QC Date

September 7, 2006

Last Update Submit

June 17, 2009

Conditions

MALT Lymphoma

Keywords

MALT Lymphomathalidomidedisseminated MALT Lymphoma or at relapse following HP-eradicationor chemotherapy or radiation

Outcome Measures

Primary Outcomes (1)

  • To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma

    6 months

Secondary Outcomes (2)

  • To evaluate the safety of thalidomide in this patient population and to evaluate

    6 months

  • The impact of thalidomide on progression free survival

    12 months

Interventions

Thalidomide, PharmionDRUG

200 mg p.o. daily

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically confirmed MALT lymphoma with measurable disease (Stage I-IV)
  • With first or greater relapse after HP-eradication, radiation or chemotherapy
  • Age \> 18
  • Must be able to tolerate therapy and have adequate cardiac, renal and hepatic function
  • ECOG status \_\< 2
  • Must be capable of understanding the purpose of the study and have given written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Internal Medicine I

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Markus Raderer, Prof

    Department of Internal Medicine I

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

June 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 18, 2009

Record last verified: 2009-06

Locations

AU(1)