Modified Hyper-CVAD in ALL
Trial question
What is the role of incorporation of rituximab into the hyper-CVAD regimen in patients with de novo Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia?
Study design
Single center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 282
282 patients (121 female, 161 male).
Inclusion criteria: adolescent and adult patients with de novo Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia.
Interventions
N=173 modified hyper-CVAD regimen (rituximab plus fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone).
N=109 standard hyper-CVAD regimen (fractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone).
Primary outcome
Complete remission duration at 3 years in patients aged < 60 years and cluster of differentiation 20-positive subset
70%
38%
70.0 %
52.5 %
35.0 %
17.5 %
0.0 %
Modified hyper-CVAD
regimen
Standard hyper-CVAD
regimen
Significant
increase ▲
NNT = 3
Significant increase in complete remission duration at 3 years in patients aged < 60 years and CD20-positive subset (70% vs. 38%; RR 1.84, 95% CI 0.75 to 2.93).
Secondary outcomes
Significant increase in overall survival at 3 years in patients aged < 60 years and CD20-positive subset (75% vs. 47%; RR 1.6, 95% CI 0.55 to 2.65).
Conclusion
In adolescent and adult patients with de novo Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, modified hyper-CVAD regimen were superior to standard hyper-CVAD regimen with respect to complete remission duration at 3 years in patients aged < 60 years and CD20-positive subset.
Reference
Deborah A Thomas, Susan O'Brien, Stefan Faderl et al. Chemoimmunotherapy with a modified hyper-CVAD and rituximab regimen improves outcome in de novo Philadelphia chromosome-negative precursor B-lineage acute lymphoblastic leukemia. J Clin Oncol. 2010 Aug 20;28(24):3880-9.
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