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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00373646 |
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Date of registration:
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07/09/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Thalidomide in Mucosa Associated Lymphoid Tissue (MALT) Lymphoma Patients
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Scientific title:
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Phase II Trial of Thalidomide (Thalidomide Pharmion) in Patients With Advanced or Relapsed Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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8 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00373646 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Austria
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Contacts
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Name:
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Markus Raderer, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Internal Medicine I |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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MALT Lymphoma
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Intervention(s)
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Drug: Thalidomide, Pharmion
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Primary Outcome(s)
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To evaluate the clinical potential of thalidomide to induce objective/histologic responses in patients with MALT lymphoma
[Time Frame: 6 months]
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Secondary Outcome(s)
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To evaluate the safety of thalidomide in this patient population and to evaluate
[Time Frame: 6 months]
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The impact of thalidomide on progression free survival
[Time Frame: 12 months]
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Secondary ID(s)
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Thalidomide-MALT
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Eudract number 2005-000008-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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