Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
Phase II Randomized Study Evaluating the Addition of Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
1 other identifier
interventional
23
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 leukemia
Started Jul 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 25, 2007
CompletedFirst Posted
Study publicly available on registry
January 29, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMay 9, 2016
April 1, 2012
4.3 years
January 25, 2007
January 19, 2012
April 5, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Time from randomization to first progression or death, whichever comes first, measured in months.
2 Years post transplant or until disease progression or death
Secondary Outcomes (1)
Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days
During the first 100 days following transplant
Study Arms (2)
Etoposide + Total Body Irradiation + Rituximab
EXPERIMENTALEtoposide 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
Etoposide + Total Body Irradiation
EXPERIMENTALEtoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
Interventions
60 mg/kg IV Daily Over 4 Hours for 1 Day
3 Gy Daily for 4 Days
375 mg/m\^2 IV Weekly Over 4-8 Hours for 4 Weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Partow Kebriaei, Associate Professor
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Partow Kebriaei, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2007
First Posted
January 29, 2007
Study Start
July 1, 2005
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
May 9, 2016
Results First Posted
May 7, 2012
Record last verified: 2012-04