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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.
Last refreshed on: 3 February 2014
Main ID:  NCT00572013
Date of registration: 11/12/2007
Primary sponsor: University of Nebraska
Public title: Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Scientific title: A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma
Date of first enrolment: May 1998
Target sample size: 32
Recruitment status: Completed
Study type:  Interventional
Study design:  Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Countries of recruitment
United States
Name:   Julie M Vose, M.D.
Affiliation:  University of Nebraska
Key inclusion & exclusion criteria

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

- 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
Health Condition(s) or Problem(s) studied
Drug: BEAM
Drug: Rituxan
Procedure: Autologous stem cell transplant
Primary Outcome(s)
response rate [Time Frame: 100 day]
Secondary Outcome(s)
overall survival [Time Frame: diagnosis until death]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
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