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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00151281 |
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Date of registration:
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06/09/2005 |
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Primary sponsor: |
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Public title:
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Phase II Study of RT-PEPC in Relapsed Mantle Cell Lymphoma
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Scientific title:
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Phase II Trial of Anti-Angiogenic Therapy With RT-PEPC in Patients With Relapsed Mantle Cell Lymphoma |
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Date of first enrolment:
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November 2004 |
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Target sample size:
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46 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00151281 |
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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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Countries of recruitment
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United States
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Contacts
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Name:
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John P Leonard, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with
characteristic immunophenotypic profiles: CD5(+),CD23(-), CD19(+) or CD20(+), cyclin
D1(+), and CD10(-)
- Patient has persistent / recurrent disease after standard chemotherapy
- Patient has not received either standard or investigational drugs within the last 3
weeks
- Available frozen tumor tissue obtained since completion of last prior therapy
(rebiopsy if needed)
- Patient has measurable disease as defined by a tumor mass > 1.5 cm in one dimension
- Age > 18 years
- Absolute granulocyte count > 1000 cells/mm3
- Platelet count > 50,000 cells/mm3
- Creatinine < 2.0 x ULN
- Total bilirubin < 2.0 x ULN
- Patient has KPS > 50%
- Patient agrees to use birth control if of reproductive potential
Exclusion Criteria:
- Known central nervous system (CNS) involvement by lymphoma
- Known HIV disease
- Known peripheral neuropathy > grade 2
- Patient is pregnant or nursing
- Patient has had major surgery within the last 3 weeks
- Patient is receiving other investigational drugs
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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Non-Hodgkin's Lymphoma
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Intervention(s)
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Drug: Rituximab, Thalidomide, Prednisone, Etoposide, Procarbazine, Cyclophosphamide
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Primary Outcome(s)
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effect of drug combination on mantle cell lymphoma
[Time Frame: duration of study]
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Secondary ID(s)
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047080073974
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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