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

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	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:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Radiation Therapy

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:

To find out if giving rituximab with etoposide and total body irradiation (TBI) will help to control ALL in patients scheduled to receive an allogeneic hematopoietic stem cell transplantation (SCT). [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To find the effect of this treatment on the occurrence of graft versus host disease (GVHD) in study participants. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	July 2005
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Etoposide + Total Body Irradiation + Rituximab	Drug: Etoposide 60 mg/kg IV Daily Over 4 Hours x 1 Day Radiation: Total Body Irradiation 3 Gy Daily x 4 Days Drug: Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours x 4 Weeks
2: Experimental Etoposide + Total Body Irradiation	Drug: Etoposide 60 mg/kg IV Daily Over 4 Hours x 1 Day Radiation: Total Body Irradiation 3 Gy Daily x 4 Days

Show Detailed Description

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 SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not clinically significant.
Adequate pulmonary function with FEV1, FVC and 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 PI.
Patients with active 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

U.T.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:	U.T.M.D. Anderson Cancer Center ( Partow Kebriaei, MD/Assistant Professor )
Study ID Numbers:	2004-0989
Study First Received:	January 25, 2007
Last Updated:	October 31, 2008
ClinicalTrials.gov Identifier:	NCT00427791 History of Changes
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

Study placed in the following topic categories:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Immunologic Factors
Rituximab
Etoposide phosphate
Leukemia

Lymphatic Diseases
Antirheumatic Agents
Lymphoproliferative Disorders
Lymphoma
Etoposide
Antineoplastic Agents, Phytogenic
Acute Lymphoblastic Leukemia

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Rituximab
Physiological Effects of Drugs
Etoposide phosphate

Pharmacologic Actions
Leukemia
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Antirheumatic Agents
Lymphoproliferative Disorders
Etoposide
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on July 02, 2009