Rituximab & Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkin's Lymphoma

August 29, 2023 updated by: University of Nebraska

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

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients who have relapsed or refractory non-Hodgkin's lymphoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the complete and partial response rate of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma treated with rituximab and high-dose carmustine, etoposide, cytarabine and melphalan followed by autologous bone marrow or peripheral blood stem cell transplantation. II. Determine the toxicity profile of this regimen in these patients. III. Compare the levels of soluble CD20 antigen and rituximab blood levels with patient outcomes in this patient population.

OUTLINE: Patients receive two doses of rituximab IV over 3-4 hours 1 week apart. Stem cells from the peripheral blood or bone marrow are collected at least 1 week after the second dose of rituximab. Following stem cell collection, patients receive a third dose of rituximab IV as above between days -10 and -6. Patients then receive high-dose chemotherapy consisting of carmustine IV on day -6, etoposide IV twice daily and cytarabine IV on days -5 to -2, and melphalan IV on day -1. On day 0 patients undergo autologous bone marrow or peripheral blood stem cell transplantation. After transplantation, patients receive a fourth dose of rituximab as above at approximately day 30, and then weekly over 4 weeks at approximately 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 year and then annually thereafter.

PROJECTED ACCRUAL: A total of 23-40 patients will be accrued for this study within 3 years.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of CD20-positive B-cell non-Hodgkin's lymphoma
  • Transplantation candidate
  • Primary induction failure
  • Chemotherapy refractory disease
  • Received at least 3 prior chemotherapy regimens or diagnosis of mantle cell lymphoma
  • Age 19 and over
  • Performance status: WHO 0-2
  • Life expectancy at least 6 months
  • Absolute neutrophil count at least 1,000/mm3 (unless due to lymphomatous involvement of the marrow)
  • Platelet count more than 50,000/mm3 (unless due to lymphomatous involvement of the marrow)
  • Hemoglobin more than 9.0 g/dL (unless due to lymphomatous involvement of the marrow)
  • Fertile patients must use effective contraception
  • Concurrent non-steroidal hormones for non-lymphoma-related conditions (e.g., insulin for diabetes) allowed

Exclusion Criteria:

  • No other concurrent chemotherapy
  • No concurrent corticosteroids except for transient control or prevention of nausea or vomiting
  • No concurrent external beam radiotherapy during transplantation therapy
  • No other concurrent antitumoral or investigational agents
  • No history of T-cell lymphoma
  • No relapse or progression after rituximab therapy within 3 months before transplantation
  • No serious disease or condition that would preclude study
  • Not pregnant or nursing/negative pregnancy test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Rituxan and BEAM with autologous stem cell transplant
Biological: rituximab
Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.
Other Names:
  • Rituxan
Drug: carmustine
BCNU 300 mg/M2 IV day -6
Other Names:
  • BCNU
Drug: cytarabine
100 mg/m2 on days -5 through -2
Other Names:
  • BEAM chemotherapy regimen
Drug: etoposide
100mg/M2 BID on days -5 through -2
Other Names:
  • BEAM chemotherapy regimen
Drug: melphalan
140 mg/m2 IV on day -1
Other Names:
  • BEAM chemotherapy regimen
Procedure: autologous hematopoietic stem cell transplantation
Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
100 day (complete + partial) response rate
Time Frame: 100 days
The primary endpoint for this study is 100 day (complete + partial) response rate
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Collaborators

National Cancer Institute (NCI)
Genentech, Inc.

Investigators

  • Principal Investigator: Julie M Vose, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2000

Primary Completion (Actual)

January 1, 2002

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

January 6, 2001

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimated)

February 12, 2004

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0045-00-FB
  • P30CA036727 (U.S. NIH Grant/Contract)
  • NCI-V00-1634 (Other Grant/Funding Number: National Cancer Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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