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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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11 September 2023 |
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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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Prospective Registration:
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No |
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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 12, 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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https://clinicaltrials.gov/ct2/show/NCT00572013 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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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, 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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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).
o 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
- WHO performance status greater or equal to 2
- Male or female subjects of reproductive potential who are able to follow accepted
birth control measures.
Exclusion Criteria:
- No history of T-cell lymphoma
- Not pregnant or lactating women
- No serious disease or condition that, in the opinion of the investigator, would
compromise the subject's ability to participate in the study
Age minimum:
19 Years
Age maximum:
N/A
Gender:
All
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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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Procedure: Autologous stem cell transplant
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Drug: BEAM
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Drug: Rituxan
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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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0138-98-FB
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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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