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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00526305
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 5, 2010
Information provided by:
PETHEMA Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: L-Asparaginase Drug: Mitoxantrone Drug: Cytosine Arabinoside Drug: Hydrocortisone Drug: Mercaptopurine Drug: Cyclophosphamide Drug: Dexamethasone Phase 4

Detailed 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


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


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.


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.


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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Study Start Date : January 2000
Primary Completion Date : April 2005
Study Completion Date : April 2005

Intervention Details:
    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

Primary Outcome Measures :
  1. To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival [ Time Frame: 5 years ]

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00526305

  Show 50 Study Locations
Sponsors and Collaborators
PETHEMA Foundation
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital

Additional Information:
Responsible Party: Pethema, pethema Identifier: NCT00526305     History of Changes
Other Study ID Numbers: LAL-Ph-2000
First Posted: September 10, 2007    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: January 2010

Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia
Chromosome Philadelphia positive

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents