Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
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
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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
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:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Etoposide |
Etoposide phosphate Rituximab Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013