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

PETHEMA Foundation

Status and phase: Completed; Phase 4

Conditions: Acute Lymphoblastic Leukemia

Treatments: Drug: Cytosine Arabinoside; Drug: Hydrocortisone; Drug: L-Asparaginase; Drug: Dexamethasone; Drug: Mitoxantrone; Drug: Mercaptopurine; Drug: Vincristine; Drug: Cyclophosphamide; Drug: Prednisone; Drug: Daunorubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT00526305

LAL-Ph-2000

Details and patient eligibility

About

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.

Full description

Remission Induction:

• Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8
• Daunorubicin (DNR): 60 mg/m2 i.v., days 1 and 8.
• Prednisone (PDN): 60 mg/m2/day, i.v. or p.o., days 1 to 14
• L-asparaginase (L-ASA): 10.000 UI/m2, i.v.days 5-7 and 11-13

Results:

1. Standard response: The induction treatment will be completed with the same drugs, changing L-ASA to ARA-C, during two more weeks

2 Slow response. Chemotherapy with mitoxantrone and high dose ARA-C

Intrathecal chemotherapy:

Treatment with mitoxantrone, ARA-C e hydrocortisone, days 1 and 22

CONSOLIDATION TREATMENT 1

Start in two weeks after last dose of induction chemotherapy:

• Mercaptopurine (MP) 50 mg/m2, p.o., days 1-7, 28-35 and 56-63
• Mitoxantrone (MTX): 3g/m2, i.v., in 24 hours, day 1, 28 and 56.
• VM-26: 150 mg/m2 every 12 horas, i.v. (infusión 1 hora), días 14 y 42
• ARA-C: 500 mg/m2 cada 12 hours, i.v., in 3 hours, days 14-15 and 42-43
• Intrathecal treatment, days 28 and 56.

6.4. CONSOLIDATION TREATMENT 2

Start in a week after last dose of mercaptopurine of previous cycle

• Dexamethasone (DXM):
• 10 mg/m2 day, p.o. or i.v. days 1-14
• 5 mg/m2 day, p.o. or i.v., days 15-21
• Vincristine (VCR): 1,5 mg/m2 i.v., days 1 and 8 and 15
• Daunorubicin (DNR): 30 mg/m2 i.v., days 1, 2, 8 and 9.
• CFM 600 mg/m2 day, i.v., days 1 and 15
• L-asparaginase (L-ASA): 10.000 UI/m2, i.v.or im , days 1-3 and 15-17
• Intrathecal treatment days 1 and 15.

TRANSPLANTATION

Hematopoietic autologous transplantation with related donor, one or two months after last dose of consolidation treatment.

Hematopoietic autologous transplantation with unrelated donor, in patients younger than 45, and with PS 0-1

Hematopoietic autologous transplantation in patients without related donor and without unrelated donor after six months searching

Enrollment: 100 estimated patients

Sex: All

Ages: Under 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

ALL BCR/ABL+ patients Age < 65 years No previous treatment

Exclusion criteria

1. Other LLA variability
2. Previous history of coronary valvular, hypertensive cardiopathy illness
3. Chronic hepatic illness
4. Chronic respiratory insufficiency
5. Renal insufficiency not caused by LLA
6. Severe neurological problems not caused by LLA
7. Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)