NCT01156883

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 18 Years – 34 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
DRUG	asparaginase
DRUG	cyclophosphamide
DRUG	cytarabine
DRUG	daunorubicin hydrochloride
DRUG	dexamethasone
DRUG	doxorubicin hydrochloride
DRUG	ifosfamide
DRUG	mercaptopurine
DRUG	methotrexate
DRUG	methylprednisolone
DRUG	prednisone
DRUG	thioguanine
DRUG	vincristine sulfate
DRUG	vindesine

Timeline

• Start date: 2010-04-01
• Primary completion: 2017-10-31
• Completion: 2017-10-31
• First posted: 2010-07-05
• Last updated: 2021-09-13

Locations

43 sites across 1 country: Italy