Status:
COMPLETED
Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE2
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 (...
Detailed Description
Disease relapse and GVHD are 2 factors that significantly impact survival in ALL patients who receive SCT. GVHD occurs when donor cells (graft) attack the stem cell recipient's (host's) cells. The ter...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00427791
Start Date
July 1 2005
End Date
October 1 2009
Last Update
May 9 2016
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030