Treatment of High Risk Adult Acute Lymphoblastic Leukemia

Summary

Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

DRUG

Vincristine

Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)

DRUG

Daunorubicin

Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22

DRUG

Prednisone

Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28

DRUG

Mitoxantrone

Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation

DRUG

Cytosine Arabinoside

ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction

DRUG

Dexamethasone

Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)

DRUG

Methotrexate (MTX)

Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT

DRUG

Cytarabine

Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal

DRUG

ASP

ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)

DRUG

Mercaptopurine

Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation

DRUG

Teniposide

Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3

DRUG

Hydrocortisone

Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal

Sponsors & Collaborators

• PETHEMA Foundation

  lead OTHER

Principal Investigators

• Ribera Josep Mª, Dr · PETHEMA Foundation

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-01-31

Primary Completion

2012-11-30

Completion

2012-12-31

Countries

• Spain

Study Locations