At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
GRASPAdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Escalating Dose Phase IIa Study of L-Asparaginase Encapsulated in Erythrocytes (GRASPA®) in Association With Polychemotherapy During Induction Phase for Treatment of Elderly Patients With Acute Lymphoblastic Leukaemia (ALL), Aged 55 Years and Over, With Philadelphia Chromosome-negative (ALL Ph-)
In Brief
A Phase 2 clinical trial evaluating GRASPA for Acute Lymphoblastic Leukemia. Completed, enrolled 30 participants.
Detailed Summary
The main purpose of this study is to determine the maximum tolerated and efficient dose of GRASPA® in combination with polychemotherapy treatment of elderly patients with ALL, 55 years and over, Philadelphia chromosome-negative (ALL Ph-).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Lymphoblastic Leukemia
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
Primary CompletionJan 2011
First PostedFeb 2012
Study CompletionOct 2012
TodayJul 2026
First PostedFeb 1, 2012
Enrollment StartApr 1, 2009
Primary CompletionJan 1, 2011
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago
Interventions
GRASPAdrug
Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase