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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: |
NCT00572013 |
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Date of registration:
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11/12/2007 |
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Primary sponsor: |
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Public title:
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Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
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Scientific title:
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A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma |
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Date of first enrolment:
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May 1998 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00572013 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: 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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Julie M Vose, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Nebraska |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Any low-grade B-cell, CD20 positive, non-Hodgkin's lymphoma that is felt to otherwise
be a transplant candidate (relapsed, induction failure, first PR or CR).
Specifically: Small lymphocytic, marginal zone, mantle cell, and follicular
histologies.
- At least 19 years of age
- Signed written informed consent
- Expected survival of at least 6 months
- Subjects with out history of T-cell lymphoma
- WHO performance status greater or equal to 2
- Subjects without serious disease or condition that, in the opinion of the
investigator, would compromise the subject's ability to participate in the study.
- Non-pregnant and non-lactating women
- Male or female subjects of reproductive potential who are able to follow accepted
birth control measures.
Age minimum:
19 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma
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Intervention(s)
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Drug: BEAM
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Drug: Rituxan
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Procedure: Autologous stem cell transplant
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Primary Outcome(s)
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response rate
[Time Frame: 100 day]
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Secondary Outcome(s)
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overall survival
[Time Frame: diagnosis until death]
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Secondary ID(s)
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138-98
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IRB#138-98
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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