Phase 2
N=23
Rituximab to the Preparative Regimen of Etoposide and Total Body Irradiation in Acute Lymphoblastic Leukemia
Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00427791 ↗Enrolled (actual)
23
Serious AEs
52.2%
Results posted
May 2012
Primary outcome: Primary: Progression-free Survival (PFS) — 4.3; 14.5 Months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Etoposide (Drug); Total Body Irradiation (Radiation); Rituximab (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) |
4.3; 14.5 | — |
| SECONDARY Number of Participants With Incidence of Acute Graft Versus Host Disease During First 100 Days |
5; 9 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00427791). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.