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

NCT00572013 | Completed Phase 1 DMC

• 1 other identifier: 0138-98-FB
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  Disease response at day 100

  100 day

Secondary Outcomes (1)

• Overall survival

  diagnosis until death

Study Arms (1)

Arm I Rituxan and BEAM post-autologous stem cell transplant

EXPERIMENTAL

Rituxan and BEAM \[Carmustine (BCNU), Etoposide, Cytarabine (Ara-C, cytosine arabinoside), Melphalan\] will be a pre- and post-transplant agent to aid in the chemotherapy sensitization post-autologous stem cell transplant.

Drug: Rituxan; Drug: BEAM; Procedure: Autologous stem cell transplant

Interventions

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

Also known as: Rituximab

Arm I Rituxan and BEAM post-autologous stem cell transplant

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

Arm I Rituxan and BEAM post-autologous stem cell transplant

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

Arm I Rituxan and BEAM post-autologous stem cell transplant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, Section of Oncology/Hematology

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Julie M Vose, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: May 12, 1998
• Primary Completion: January 1, 2001
• Study Completion: September 18, 2009
• Last Updated: September 7, 2023

Record last verified: 2023-09

Locations

US (1)