CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 470 enrolled
Drug / intervention
asparaginase +14 moredrug
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.

Search/NCT00458848
NCT00458848Phase 2Completed

Phase II Study of Adult Acute Lymphoblastic Leukaemia (ALL): Imatinib in Combination With Chemotherapy in Ph+ Patients, and Post-remissional Treatment Intensification in High-risk Ph- Patients, With Minimal Residual Disease Monitoring.

Gruppo Italiano Malattie EMatologiche dell'Adulto·interventional·Posted Apr 11, 2007·Updated Feb 15, 2019

In Brief

A Phase 2 clinical trial evaluating asparaginase, daunorubicin hydrochloride, and 13 other interventions for Leukemia. Completed, enrolled 470 participants across 66 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. When the healthy stem cells are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving combination chemotherapy together with imatinib mesylate and peripheral stem cell transplant may be an effective treatment for acute lymphoblastic leukemia. Nevertheless, in the last few years GIMEMA has pubblished a paper in which 100% of Ph+ ALL patients reach HCR only with Imatinib, without any chemiotherapy. Thus, this treatment will be implemented in patients pertaining to this category.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2007
Enrollment StartOct 1, 2004
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 19.2 years ago

Interventions

asparaginasedrug

daunorubicin hydrochloridedrug

etoposidedrug

idarubicindrug

imatinib mesylatedrug

mercaptopurinedrug

methotrexatedrug

methylprednisolonedrug

mitoxantrone hydrochloridedrug

prednisonedrug

vincristine sulfatedrug

allogeneic hematopoietic stem cell transplantationprocedure

autologous hematopoietic stem cell transplantationprocedure

peripheral blood stem cell transplantationprocedure

radiation therapyradiation