Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01156883

Acronym

LAL1308

Enrollment

Registered

2010-07-05

Start date

2010-04-30

Completion date

2017-10-31

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

B-cell adult acute lymphoblastic leukemia, recurrent adult acute lymphoblastic leukemia, T-cell adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia

Brief 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. 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.

Detailed 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.

Interventions

DRUGasparaginase

DRUGcyclophosphamide

DRUGcytarabine

DRUGdaunorubicin hydrochloride

DRUGdexamethasone

DRUGdoxorubicin hydrochloride

DRUGifosfamide

DRUGmercaptopurine

DRUGmethotrexate

DRUGmethylprednisolone

DRUGprednisone

DRUGthioguanine

DRUGvincristine sulfate

DRUGvindesine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 34 Years

Healthy volunteers

Inclusion 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: * Not specified PRIOR CONCURRENT THERAPY: * Prior pretreatment with antiblastic chemotherapy allowed

Design outcomes

Primary

Measure	Time frame	Description
Treatment feasibility	At 24 months from study entry.	To determinate if the Risk-adapted, MRD-directed therapy improves the estimation of Overall Survival (OS) at 24 months from study entry.

Secondary

Measure	Time frame	Description
Disease free survival	At three years from study entry	Estimation of Disease Free Survival (DFS).
Event free survival	At 3 years from study entry	Estimation of Event Free Survival (EFS).
Overal survival	At 3 years from study entry	—
Safety	At 3 years from study entry	Grade III-IV toxicity events
Compliance	At 3 years from study entry	Therapy compliance

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026