Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia - Full Text View

Sponsor:	M.D. Anderson Cancer Center
Information provided by (Responsible Party):	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00427791

Purpose

Primary Objective:

To determine the progression free survival (PFS) of the preparative regimen rituximab, etoposide and total body irradiation (TBI), in patients with acute lymphoblastic leukemia (ALL) receiving allogeneic hematopoietic stem cell transplantation (SCT).

Secondary Objectives:

To determine the effect of rituximab on the incidence of acute graft vs. host disease (GVHD).
To determine the efficacy of adding imatinib mesylate post transplant in ALL patients with the t(9;22)(q34;q11) cytogenetic abnormality.
To estimate the probability of molecular complete remission at one year for the described treatment approach as determined by serial minimal residual disease (MRD) monitoring.
To determine the rate of GVHD, engraftment, toxicity, and overall survival (OS) for this treatment regimen.

Condition	Intervention	Phase
Leukemia	Drug: Etoposide Radiation: Total Body Irradiation 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:	Phase II Randomized Study Evaluating the Addition of Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

Resource links provided by NLM:

MedlinePlus related topics: Acute Lymphocytic Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia

Drug Information available for: Etoposide Etoposide phosphate Rituximab

U.S. FDA Resources

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

Primary Outcome Measures:

Progression-free survival (PFS) [ Time Frame: 2 Years post transplant or until disease progression or death ] [ Designated as safety issue: No ]
Time from randomization to first progression or death, whichever comes first, measured in months. PFS estimated with the Kaplan-Meier (1958) product-limit estimator for each treatment group, and PFS compared between the 2 treatment groups with the log-rank test.

Secondary Outcome Measures:

Incidence of Acute Graft Versus Host Disease (GVHD) [ Time Frame: During the first 100 days following transplant, and then every 3 months during the first 2 years. ] [ Designated as safety issue: No ]
Cumulative incidence of acute graft versus host disease (aGVHD) by 100 days and molecular complete remission by 1 year with the methods of Gooley, et al. (1999) for each treatment group.

Enrollment:	23
Study Start Date:	July 2005
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Etoposide + Total Body Irradiation + Rituximab Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks	Drug: Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day Radiation: Total Body Irradiation 3 Gy Daily for 4 Days Other Name: TBI Drug: Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks Other Name: Rituxan
Experimental: Etoposide + Total Body Irradiation Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days	Drug: Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day Radiation: Total Body Irradiation 3 Gy Daily for 4 Days Other Name: TBI

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Eligibility

Ages Eligible for Study:	up to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with biopsy-proven ALL in remission or relapse.
Adequate renal function, as defined by estimated serum creatinine clearance >50 ml/min and/or serum creatinine <1.8 mg/dL.
Adequate hepatic function, as defined by aspartate aminotransferase (AST or SGOT) <3 * upper limit of normal; serum bilirubin and alkaline phosphatase <2 * upper limit of normal, or considered not clinically significant.
Adequate pulmonary function with Forced Expiratory Volume in One Second (FEV1), forced vital capacity (FVC) and Carbon Monoxide Diffusing Capacity (DLCO) at least 45% of expected corrected for hemoglobin.
Adequate cardiac function with left ventricular ejection fraction at least 45%. No uncontrolled arrhythmias or symptomatic cardiac disease.
Zubrod performance status <2.
Patients must have a related, genotypically HLA identical donor, or they must have a related or unrelated donor who is at least a 9/10 HLA match by high resolution typing.
Female patient must not be pregnant and have negative pregnancy test.
Patient and donor should be willing to participate in the study by providing written consent.

Exclusion Criteria:

Patients with unresolved grade 3 or greater non-hematologic toxicity from previous therapy. Patients with grade 2 toxicity will be eligible at the discretion of the principal investigator (PI).
Patients with active central nervous system (CNS) disease.
Evidence of acute or chronic active hepatitis or cirrhosis.
Uncontrolled infection, including HIV or HTLV-1 infection.
Patients greater than 60 years-old.
Prior autologous or allogeneic hematopoietic stem cell transplant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427791

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Partow Kebriaei, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00427791 History of Changes
Other Study ID Numbers:	2004-0989
Study First Received:	January 25, 2007
Last Updated:	September 26, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Lymphoblastic Leukemia
Leukemia
Total Body Irradiation
Etoposide

Rituximab
Rituxan
TBI
ALL

Additional relevant MeSH terms:

Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide

Etoposide phosphate
Rituximab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 12, 2012