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Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia

NCT00458848 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 470

Last updated 2019-02-15

Study results available
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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.

Conditions

Interventions

DRUG

asparaginase

DRUG

daunorubicin hydrochloride

DRUG

etoposide

DRUG

idarubicin

DRUG

imatinib mesylate

DRUG

mercaptopurine

DRUG

methotrexate

DRUG

methylprednisolone

DRUG

mitoxantrone hydrochloride

DRUG

prednisone

DRUG

vincristine sulfate

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

autologous hematopoietic stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

RADIATION

radiation therapy

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    lead OTHER

Principal Investigators

  • Roberto Foa, MD · Universita Degli Studi "La Sapeinza"

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Italy

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458848 on ClinicalTrials.gov