Combination Chemotherapy in Treating Young Adult Patients With Acute Lymphoblastic Leukemia

Not Applicable

Completed

• Conditions: Leukemia

• Registration Number: NCT01156883
• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-02
• Study First Posted: 2010-07-05
• Primary Completion: 2017-10-31
• Study Completion: 2017-10-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-06
• Last Update Posted: 2021-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Compliance	At 3 years from study entry	Therapy compliance
Safety	At 3 years from study entry	Grade III-IV toxicity events

Trial Locations

Locations (43)

Complesso Ospedaliero S. Giovanni Addolorata; 🇮🇹 Roma, (rm), Italy

Azienda Ospedaliera - Nuovo Ospedale "Torrette"; 🇮🇹 Ancona, Italy

USL 8 - Ospedale S.Donato; 🇮🇹 Arezzo, Italy

Dipartimento Area Medica - Presidio Ospedaliero "C. e G.Mazzoni"; 🇮🇹 Ascoli Piceno, Italy

Az.Ospedaliera S.G.Moscati; 🇮🇹 Avellino, Italy

UO Ematologia con trapianto- AOU Policlinico Consorziale di Bari; 🇮🇹 Bari, Italy

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi; 🇮🇹 Bologna, Italy

Divisione di Ematologia Ospedale A. Perrino; 🇮🇹 Brindisi, Italy

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"; 🇮🇹 Catania, Italy

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia; 🇮🇹 Catanzaro, Italy

Scroll for more (33 remaining)