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

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ClinicalTrials.gov Identifier: NCT00526305
Recruitment Status : Completed
First Posted : September 10, 2007
Last Update Posted : January 5, 2010
Sponsor:
Information provided by:
PETHEMA Foundation

Tracking Information
First Submitted Date  ICMJE September 5, 2007
First Posted Date  ICMJE September 10, 2007
Last Update Posted Date January 5, 2010
Study Start Date  ICMJE January 2000
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2008)
To evaluate the efficacy of treatment in order to response rate, relapse free survival and overall survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00526305 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
Official Title  ICMJE LAL-Ph-2000: Treatment of Acute Lymphoblastic Leukemia Chromosome Philadelphia Positive
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.
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

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 6, 2007)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion Date April 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00526305
Other Study ID Numbers  ICMJE LAL-Ph-2000
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pethema, pethema
Study Sponsor  ICMJE PETHEMA Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
PRS Account PETHEMA Foundation
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP