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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


Phase 1/Phase 2
19 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase I/II Trial of Rituxan and BEAM High-Dose Chemotherapy and Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma


Objectives: I. To determine the response rate, complete and partial, of patients with
indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant. II. To
determine if the addition of Rituxan changes the toxicity profile attributed to high-dose
BEAM chemotherapy.

This protocol is a phase I/II trial combining the Rituxan as a pre and post-transplant agent
to aid in the chemotherapy sensitization and the treatment of minimal residual disease
post-transplant.


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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

100 day

Safety Issue:

No

Principal Investigator

Julie M Vose, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Nebraska

Authority:

United States: Institutional Review Board

Study ID:

138-98

NCT ID:

NCT00572013

Start Date:

May 1998

Completion Date:

September 2009

Related Keywords:

  • Lymphoma
  • Lymphoma

Name

Location

University of Nebraska Medical Center, Section of Oncology/HematologyOmaha, Nebraska  68198-7680