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NCT Number: NCT00007852

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

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Key information

Conditions

Lymphoma Burkitt Lymphoma Chronic Disease DNA Virus Infections Disease Attributes Epstein-Barr Virus Infections Hematologic Diseases Hemic and Lymphatic Diseases Herpesviridae Infections Immune System Diseases Immunoproliferative Disorders Infections Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor Virus Infections Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Rituximab

Biological

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

carmustine

Drug

BCNU 300 mg/M2 IV day -6

Other names: BCNU

Cytarabine

Drug

100 mg/m2 on days -5 through -2

Other names: BEAM chemotherapy regimen

etoposide

Drug

100mg/M2 BID on days -5 through -2

Other names: BEAM chemotherapy regimen

melphalan

Drug

140 mg/m2 IV on day -1

Other names: BEAM chemotherapy regimen

autologous hematopoietic stem cell transplantation

Procedure

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

Primary outcomes

  1. 100 day (complete + partial) response rate

    Time frame: 100 days

    The primary endpoint for this study is 100 day (complete + partial) response rate

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Genentech, Inc.
  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2002
Study completion
2011
First posted
Feb 12, 2004
Registry last updated
Sep 1, 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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