Overview

This trial is active, not recruiting.

Condition leukemia
Treatments asparaginase, cyclophosphamide, cytarabine, daunorubicin hydrochloride, dexamethasone, doxorubicin hydrochloride, ifosfamide, mercaptopurine, methotrexate, methylprednisolone, prednisone, thioguanine, vincristine sulfate, vindesine
Sponsor Gruppo Italiano Malattie EMatologiche dell'Adulto
Start date April 2010
End date November 2014
Trial size 30 participants
Trial identifier NCT01156883, EU-21042, GIMEMA-LAL1308, LAL1308

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Treatment feasibility
time frame: At 24 months from study entry.

Secondary Outcomes

Measure
Disease free survival
time frame: At three years from study entry
Event free survival
time frame: At 3 years from study entry
Overal survival
time frame: At 3 years from study entry
Toxicity
time frame: At 3 years from study entry
Compliance
time frame: At 3 years from study entry

Eligibility Criteria

Male or female participants from 18 years up to 34 years old.

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

Additional Information

Official title Young Adult Acute Lymphoid Leukemia (ALL): Intensification of Pediatric AIEOP LLA-2000 Treatment
Principal investigator Roberto Foa, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gruppo Italiano Malattie EMatologiche dell'Adulto.