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

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

MedlinePlus related topics:

Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood

ChemIDplus related topics:

Etoposide Rituximab Etoposide phosphate

U.S. FDA Resources

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

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:

The effect of this treatment on the occurrence of graft versus host disease (GVHD) in these patients will also be studied. [ 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

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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 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

Contacts


Contact: Partow Kebriaei, MD	713-745-0663

Locations


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

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Partow Kebriaei, MD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Partow Kebriaei, MD/Assistant Professor )
Study ID Numbers:	2004-0989
First Received:	January 25, 2007
Last Updated:	June 2, 2008
ClinicalTrials.gov Identifier:	NCT00427791
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Acute Lymphoblastic Leukemia

Leukemia

Total Body Irradiation

Etoposide

Rituximab

TBI

ALL

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Rituximab

Lymphoproliferative Disorders

Etoposide phosphate

Etoposide

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immunologic Factors

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Physiological Effects of Drugs

Antirheumatic Agents

Antineoplastic Agents, Phytogenic

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00427791