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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

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

U.S. FDA Resources

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

Primary Outcome Measures:

Disease-free survival (DFS) [ Time Frame: 3 months and 6 months after transplantation, then every 6 months for 3 years, and then once a year up to 5 years from the transplant date. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	March 2005
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab	Drug: Carmustine 300 mg/m^2 IV vein x 1 Day Other Names: BCNU BiCNU 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 Other Name: VePesid 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 Other Names: Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: Melphalan 140 mg/m^2 IV x 1 Day Drug: Rituximab Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion. Other Name: Rituxan
Experimental: Cohort 2 BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab	Drug: Carmustine 300 mg/m^2 IV vein x 1 Day Other Names: BCNU BiCNU 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 Other Name: VePesid 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 Other Names: Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Drug: Melphalan 140 mg/m^2 IV x 1 Day Drug: Rituximab Cohort 1, High-Dose Rituximab = 1000 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion; Cohort 2, Standard Dose Rituximab = 375 mg/m^2 IV On Days +1 and +8 After Stem Cell Infusion. Other Name: Rituxan

Arms

Assigned Interventions

Experimental: Cohort 1

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

Drug: Carmustine

300 mg/m^2 IV vein x 1 Day

Other Names:

BCNU
BiCNU

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

Other Name: VePesid

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

Other Names:

Ara-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride

Drug: Melphalan

140 mg/m^2 IV x 1 Day

Drug: Rituximab

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

Other Name: Rituxan

Experimental: Cohort 2

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

Drug: Carmustine

300 mg/m^2 IV vein x 1 Day

Other Names:

BCNU
BiCNU

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

Other Name: VePesid

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

Other Names:

Ara-C
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride

Drug: Melphalan

140 mg/m^2 IV x 1 Day

Drug: Rituximab

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

Other Name: Rituxan

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

Locations

United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Chitra M. Hosing, MD

UT MD Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Chitra M. Hosing, MD/Associate Professor, U.T.M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00472056 History of Changes
Other Study ID Numbers:	2004-0271
Study First Received:	May 9, 2007
Last Updated:	July 29, 2011
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
BCNU
BiCNU
Etoposide
VePesid

Cytarabine
Cytosar
DepoCyt
Cytosine arabinosine hydrochloride
Ara-C
Melphalan
Rituximab
Rituxan

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin
Carmustine
Melphalan
Etoposide phosphate
Rituximab
Cytarabine

Etoposide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on February 09, 2012