Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia (LAL1308)

Gruppo Italiano Malattie EMatologiche dell'Adulto

Status

Completed

Conditions

Leukemia

Treatments

Drug: cytarabine

Drug: asparaginase

Drug: thioguanine

Drug: prednisone

Drug: vindesine

Drug: vincristine sulfate

Drug: mercaptopurine

Drug: ifosfamide

Drug: doxorubicin hydrochloride

Drug: methylprednisolone

Drug: cyclophosphamide

Drug: methotrexate

Drug: daunorubicin hydrochloride

Drug: dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT01156883

LAL1308

GIMEMA-LAL1308

EU-21042

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. Giving more than one drug (combination chemotherapy) together with steroid therapy may kill more cancer cells.

PURPOSE: This clinical trial is studying the side effects of combination chemotherapy in treating young adult patients with acute lymphoblastic leukemia.

Full description

OBJECTIVES:

To determine the feasibility of combination chemotherapy in young adult patients with acute lymphoid leukemia.
To determine the complete response rate at the end of induction therapy in these patients.
To determine the overall survival of patients treated with these regimens.
To determine the disease-free survival of patients treated with these regimens.
To determine the event-free survival of patients treated with these regimens.
To determine toxicity of these regimens.
To determine compliance related to dose intensity.

OUTLINE:

Steroids prephase therapy: All patients receive steroids (i.e., prednisone or methylprednisolone) and methotrexate.
Induction therapy (induction Ia followed by Ib): Patients receive induction Ia comprising vincristine, daunorubicin hydrochloride, asparaginase, and prednisone. They then receive induction Ib comprising cyclophosphamide, mercaptopurine, and cytarabine. Patients who achieve hematological remission proceed to consolidation therapy.
Consolidation therapy: Patients receive consolidation therapy according to risk group.
- Standard-risk patients: Patients receive high-dose methotrexate and mercaptopurine.
- High-risk patients: Patients receive consolidation therapy in 3 steps.
  - Step 1: Patients receive dexamethasone, vincristine, methotrexate, cytarabine, and asparaginase.
  - Step 2: Patients receive dexamethasone, vindesine, methotrexate, ifosfamide, asparaginase, and daunorubicin hydrochloride.
  - Step 3: Patients receive dexamethasone, cytarabine, and asparaginase. After completion of consolidation therapy, patients proceed to reinduction therapy.
Reinduction therapy (reinduction IIa followed by IIb): Patients receive reinduction IIa comprising vincristine, doxorubicin hydrochloride, asparaginase, and dexamethasone. Patients then receive reinduction IIb comprising cyclophosphamide, thioguanine, and cytarabine.

Enrollment

76 patients

Sex

All

Ages

18 to 34 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

Diagnosis of acute lymphoid leukemia, meeting any of the following criteria:
- Non-mature B-cell disease
- Non-Philadelphia chromosome positive disease
- T -cell or B-cell phenotype

PATIENT CHARACTERISTICS: