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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007852
• Other study ID #: 0045-00-FB
• Secondary ID: P30CA036727NCI-V
• Status: Completed
• Phase: Phase 2
• Start date: September 1, 2000
• Est. completion date: January 1, 2011

Study information

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

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 1, 2011
• Est. primary completion date: January 1, 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma

Intervention

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.

Drug:
• carmustine
BCNU 300 mg/M2 IV day -6
• cytarabine
100 mg/m2 on days -5 through -2
• etoposide
100mg/M2 BID on days -5 through -2
• melphalan
140 mg/m2 IV on day -1

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (3)

Lead Sponsor	Collaborator
University of Nebraska	Genentech, Inc., National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	100 day (complete + partial) response rate	The primary endpoint for this study is 100 day (complete + partial) response rate	100 days