LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive

Summary

Due to ALL Ph+ patients should receive a different treatment, is proposed a therapeutical protocol with: intensification treatment of induction to increment the CR rate, allogenic transplantation in first CR, autologous transplantation follow by alfa interferon in patients cannot done allogenic transplantation.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

DRUG

Vincristine

1,5 mg/m2 i.v., days 1 and 8

DRUG

Daunorubicin

60 mg/m2, i.v., days 1 and 8

DRUG

Prednisone

60 mg/m2 day, i.v. or oral, days 1 to 14

DRUG

L-Asparaginase

10.000 UI/m2, i.v., days 5-7 and 11-13. Total: 6 doses.

DRUG

Mitoxantrone

12 mg/m2 i.v days 15, 16 and 17

DRUG

Cytosine Arabinoside

1.500 mg/m2 /12 hours, days 16, 17 and 18 (total: 6 doses) If slow response to treatment: 3.000 mg/m2/12 hours, days 18, 19, 20 and 21 (8 doses)

DRUG

Hydrocortisone

10 mg ,15 mg or 20 mg depending of age

DRUG

Mercaptopurine

50 mg/m2, oral, days 1 to 7, 28-35 and 56-63 in consolidation

DRUG

Cyclophosphamide

600 mg/m2 day, i.v., days 1 to 15 in consolidation

DRUG

Dexamethasone

10 mg/m2 day, oral or i.v. days 1-14 5 mg/m2 day, oral. or i.v., days 15-21

Sponsors & Collaborators

• PETHEMA Foundation

  lead OTHER

Principal Investigators

• Ribera Josep Mª, Dr · Germans Trias i Pujol Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-01-31

Primary Completion

2005-04-30

Completion

2005-04-30

Countries

• Spain

Study Locations