Rituxan and BEAM With Autologous Peripheral Blood Progenitor Transplant for Indolent Lymphoma

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572013
• Other study ID #: 0138-98-FB
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 12, 1998
• Est. completion date: September 18, 2009

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the response rate, complete and partial, of patients with indolent lymphoma receiving Rituxan and BEAM with autologous stem cell transplant.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 18, 2009
• Est. primary completion date: January 1, 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Rituxan
375mg/m2 IV on days -20 to -8. Infusion to begin at rate of 50mg/hour for 1st hour.If no toxicity rate may be increased. A second infusion 375mg/m2 given 30days post transplant and again at 60 days post transplant
• BEAM
BCNU(carmustine)on day -6 300mg/M2 IV, etoposide 100mg/M2 BID on days -5 through -2, cytarabine 100mg/m2 BID on days -5 through -2, melphalan 140mg/m2 IV on day -1

Procedure:
• Autologous stem cell transplant
following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Section of Oncology/Hematology	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Disease response at day 100	100 day
Secondary	Overall survival	Survival time from diagnosis until death	diagnosis until death