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Completed

NCT Number: NCT00526305

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

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.

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Alicante, Alicante, Spain

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About this study

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:

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Vincristine

Drug

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

Daunorubicin

Drug

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

Prednisone

Drug

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

L-Asparaginase

Drug

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

Mitoxantrone

Drug

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

Cytosine Arabinoside

Drug

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)

Hydrocortisone

Drug

10 mg ,15 mg or 20 mg depending of age

mercaptopurine

Drug

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

Cyclophosphamide

Drug

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

Dexamethasone

Drug

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

Primary outcomes

  1. To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Sep 10, 2007
Registry last updated
Jan 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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