Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00427791
First received: January 25, 2007
Last updated: April 10, 2012
Last verified: April 2012
  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 2

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:


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.


Secondary Outcome Measures:
  • Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days [ Time Frame: During the first 100 days following transplant ] [ Designated as safety issue: No ]
    Number of participants with incidence of acute graft versus host disease (aGVHD) during first 100 days following transplant.


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

  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 aspartate aminotransferase (AST) or serum glutamic oxaloacetic transaminase (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 human leukocyte antigens (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 Human immunodeficiency virus (HIV) or Human T-lymphotropic virus Type I (HTLV-1) infection.
  • Patients greater than 60 years-old.
  • Prior autologous or allogeneic hematopoietic stem cell transplant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Results First Received: January 19, 2012
Last Updated: April 10, 2012
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:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Etoposide phosphate
Etoposide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 02, 2014