Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Lymphoid Malignancies - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00472056

Purpose

Cohort 1. Patients who are less than or equal to 65 years of age.

1. To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab).

Cohort 2. Patients who are older than 65 years of age.

To determine the disease-free survival (DFS) in the 2 arms (standard dose versus high dose rituximab).
To determine the treatment related mortality (TRM).

Condition	Intervention	Phase
Lymphoma	Drug: Carmustine Drug: Etoposide Drug: Cytarabine Drug: Melphalan Drug: Rituximab	Phase II

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cytarabine Cytarabine hydrochloride Etoposide Carmustine Melphalan Rituximab Etoposide phosphate Melphalan hydrochloride Sarcolysin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Trial Using Standard Dose Versus High Dose Rituximab in Addition to Autologous Transplantation With BEAM for Patients With Diffuse Large B Cell Lymphomas

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To learn if giving high dose rituximab with transplantation and high dose chemotherapy is more effective than giving standard dose rituximab with transplantation and high dose chemotherapy in the treatment of non-Hodgkin's lymphoma. [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the safety of these two treatments. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]
To study the safety of giving autologous transplantation in patients with non-Hodgkin's lymphoma who are older than 65 years of age. [ Time Frame: 4 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cohort 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab	Drug: Carmustine 300 mg/m^2 IV x 1 Day Drug: Etoposide Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days Drug: Cytarabine Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days Drug: Melphalan 140 mg/m^2 IV x 1 Day Drug: Rituximab Arm 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Arm 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.
2: Experimental Cohort 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab	Drug: Carmustine 300 mg/m^2 IV x 1 Day Drug: Etoposide Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days Drug: Cytarabine Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days Drug: Melphalan 140 mg/m^2 IV x 1 Day Drug: Rituximab Arm 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Arm 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.

Arms

Assigned Interventions

1: Experimental

Cohort 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab

Drug: Carmustine

300 mg/m^2 IV x 1 Day

Drug: Etoposide

Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days

Drug: Cytarabine

Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days

Drug: Melphalan

140 mg/m^2 IV x 1 Day

Drug: Rituximab

Arm 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Arm 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.

2: Experimental

Cohort 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab

Drug: Carmustine

300 mg/m^2 IV x 1 Day

Drug: Etoposide

Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days

Drug: Cytarabine

Arm 1 = 200 mg/m^2 IV Every 12 Hours x 4 Days; Arm 2 = 100 mg/m^2 IV Every 12 Hours x 4 Days

Drug: Melphalan

140 mg/m^2 IV x 1 Day

Drug: Rituximab

Arm 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Arm 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion.

Show Detailed Description

Eligibility

Ages Eligible for Study:	up to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with histologically proven diffuse large B-cell (CD20 positive) or transformed follicular non-Hodgkin's lymphomas, that have relapsed after conventional chemotherapy and are not eligible for protocols of higher priority
Patients must have chemosensitive disease to salvage chemotherapy and less than 5% bone marrow involvement with lymphoma by gross pathologic examination
Age less than or equal to 80 years. There is no lower age limit for this study.
Zubrod performance status of less than 2
Negative pregnancy test in patients with child bearing potential
Must be willing to sign informed consent
Should be seronegative for HIV, hepatitis B surface antigen, hepatitis C antibody.

Exclusion Criteria:

Patients with known active CNS disease are excluded. Patients with prior history of CNS disease should have a negative MRI of the brain (and/or spine if indicated) and negative CSF cytology within 4 weeks of enrollment into the study.
Less than 3 weeks from last cytotoxic chemotherapy
Serum bilirubin > 1.5 mg/dl
Serum transaminases > 2X/ULN
Serum creatinine > 1.6 mg/dl
Failure to collect more than 3 x 1,000,000 CD34+ stem cells/kg body weight
Left ventricular ejection fraction of < 40%, unless cleared by cardiology
Corrected DLCO of < 50%
Patients who are on anticoagulants or antiplatelet agents.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472056

Contacts

Contact: Chitra M. Hosing, MD

713-792-8750

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Chitra M. Hosing, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Chitra M. Hosing, MD

U.T.M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Chitra M. Hosing, MD/Associate Professor )
Study ID Numbers:	2004-0271
Study First Received:	May 9, 2007
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00472056
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Non-Hodgkin's Lymphoma
Lymphoid Malignancies
Lymphoma
BEAM Chemotherapy
Carmustine
Etoposide

Cytarabine
Melphalan
Rituximab
BCNU
Ara-C

Study placed in the following topic categories:

Melphalan
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Carmustine
Lymphoma, small cleaved-cell, diffuse
Etoposide phosphate
Lymphoma, B-Cell

Lymphoma, large-cell
Lymphatic Diseases
B-cell lymphomas
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Etoposide
Lymphoma
Cytarabine

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immunologic Factors
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009