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Completed

NCT Number: NCT00572013

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

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

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Nebraska Medical Center, Section of Oncology/Hematology

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rituxan

Drug

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

Other names: Rituximab

BEAM

Drug

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

Autologous Stem Cell Transplant

Procedure

following chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Primary outcomes

  1. Response rate

    Time frame: 100 day

    Disease response at day 100

Secondary outcomes

  1. Overall survival

    Time frame: diagnosis until death

    Survival time from diagnosis until death

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2001
Study completion
2009
First posted
Dec 12, 2007
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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