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Completed

NCT Number: NCT00458848

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale Civile Alessandria, Alessandria, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of acute lymphoblastic leukemia (ALL) meeting the following criteria:
  • Negative myeloperoxidase stain
  • Phenotype T (T-ALL) or B (B-ALL)
  • No mature B-ALL (FAB L3, serum immunoglobulin-positive, terminal deoxynucleotidyl transferase-negative)

PATIENT CHARACTERISTICS:

  • Creatinine ≤ 2.5 mg/dL (after adequate hydration)
  • SGOT and SGPT ≤ 3 times upper limit of normal
  • LVEF ≥ 50%
  • No severe psychiatric disorders
  • No other concurrent malignant disease
  • No presence of documented infections not responding to antibiotic and/or antifungal therapy
  • Not pregnant

PRIOR CONCURRENT THERAPY:

  • No prior steroids
  • No prior antiblastic chemotherapy
  • No other concurrent chemotherapy or radiotherapy

Treatment and study plan

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

Drug

allogeneic hematopoietic stem cell transplantation

Procedure

autologous hematopoietic stem cell transplantation

Procedure

peripheral blood stem cell transplantation

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Percentage of Participants Reaching Disease Free Survival

    Time frame: At 60 months

Secondary outcomes

  1. Number of Patients Reaching Complete Hematological Response After Induction Therapy

    Time frame: At the end of induction, day +50

  2. Percentage of Participants Reaching Overall Survival

    Time frame: At 60 months

    Overall survival from diagnosis

Sponsors and collaborators

Lead sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Other

Registry information

Official study title

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.

Acronym: LAL0904

Important dates

Study start
2004
Primary completion
2014
Study completion
2014
First posted
Apr 11, 2007
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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