Chemotherapy With or Without Imatinib and/or Peripheral Stem Cell Transplant in Acute Lymphoblastic Leukemia (LAL0904)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status and phase

Completed

Phase 2

Conditions

Leukemia

Treatments

Drug: methylprednisolone

Drug: mitoxantrone hydrochloride

Drug: methotrexate

Drug: vincristine sulfate

Drug: prednisone

Drug: idarubicin

Drug: asparaginase

Procedure: peripheral blood stem cell transplantation

Procedure: allogeneic hematopoietic stem cell transplantation

Drug: imatinib mesylate

Drug: mercaptopurine

Radiation: radiation therapy

Procedure: autologous hematopoietic stem cell transplantation

Drug: daunorubicin hydrochloride

Drug: etoposide

Study type

Interventional

Funder types

Other

Identifiers

NCT00458848

LAL0904 (Other Identifier)

2004-001738-11 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

470 patients

Sex

All

Ages

15 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: