Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Medical University of Vienna.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Medical University of Vienna
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00923663
First received: June 17, 2009
Last updated: September 27, 2010
Last verified: September 2010
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Purpose
The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (MALT).
| Condition | Intervention | Phase |
|---|---|---|
|
MALT Lymphoma |
Drug: Lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type |
Resource links provided by NLM:
MedlinePlus related topics:
Lymphoma
Drug Information available for:
Lenalidomide
U.S. FDA Resources
Further study details as provided by Medical University of Vienna:
Primary Outcome Measures:
- Rate of objective responses induced by Lenalidomide [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Time to progression [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Lenalidomide
Lenalidomide administered orally at a dose of 25 mg daily
|
Drug: Lenalidomide
25 mg Lenalidomide p.o. daily for 21 days
|
Detailed Description:
The primary objective of the study is to evaluate the clinical potential of Lenalidomide to induce objective/histologic responses in patients with MALT lymphoma.
The secondary objectives are to evaluate the safety of Lenalidomide in this patient population and to evaluate the impact of Lenalidomide on progression free survival.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 in case of gastric lymphoma
- Age > 18 years
- Must be able to tolerate therapy, and have adequate cardiac, renal, and hepatic function, ECOG status of 0 - 2
- Must be capable of understanding the purpose of the study and have given written informed consent
Exclusion Criteria:
- Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
- Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
- History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
- Major surgery, other than diagnostic surgery, within the last 4 weeks
- Evidence of CNS involvement
- A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
- Severe peripheral polyneuropathy
- Clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
- Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) < 1.0 x 109/L
- Patients with active opportunistic infections
- Pregnancy
- Uncontrolled diabetes mellitus
- Preexisting thromboembolic events at start of study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923663
Contacts
| Contact: Markus Raderer, MD | +43-1-40400 ext 2296 | markus.raderer@meduniwien.ac.at |
Locations
| Austria | |
| Dept of Internal Medicine | Recruiting |
| Vienna, Austria, A-1090 | |
| Contact: Markus Raderer, MD +43-1-40400 ext 2296 markus.raderer@meduniwien.ac.at | |
| Principal Investigator: Markus Raderer, MD | |
Sponsors and Collaborators
Medical University of Vienna
More Information
No publications provided by Medical University of Vienna
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Prof Markus Raderer, Internal Medicine I, Division of Oncology, University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00923663 History of Changes |
| Other Study ID Numbers: | LEN-MALT |
| Study First Received: | June 17, 2009 |
| Last Updated: | September 27, 2010 |
| Health Authority: | Austria: Agency for Health and Food Safety |
Keywords provided by Medical University of Vienna:
|
MALT lymphoma Advanced or Helicobacter pylori-refractory MALT lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell, Marginal Zone Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lenalidomide Thalidomide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013