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Glivec in Ph Positive Lymphoblastic Leukemia

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ClinicalTrials.gov Identifier: NCT00388895
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : November 19, 2008
Sponsor:
Information provided by:
PETHEMA Foundation

Study Description
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Brief Summary:
% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Cromosome Philadelphia Positive Drug: chemotherapy Drug: Glivec Phase 2

Detailed Description:
Pilot phase II clinical trial, prospective, multicentric and opened
Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant
Study Start Date : June 2002
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. % positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment.
  2. Discover if is possible to treat patients with Glivec plus Standard consolidation treatment.
  3. Discover the Glivec effect over ERM during consolidation treatment and alter transplant

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

Inclusion Criteria:

  • New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old
  • Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
  • Performance status 0-2 (Appendix B); Is allowed performance status > 2 because of LLA
  • Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine < 1,5 mg/dl o Clearance creatinine > 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV > 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
  • Negative HIV serology
  • Written, oral or with witness informed consent. In patients < 18 years old must be signed written and legal representative informed consent.
  • No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.

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
  • Pregnancy and women
  • Blastic crisis LMC
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00388895


Locations
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Sponsors and Collaborators
PETHEMA Foundation
Investigators
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Study Chair: Ribera Josep Mª, Dr Germans Trias i Pujol Hospital
More Information
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Additional Information:

Publications:

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Responsible Party: Pethema, pethema
ClinicalTrials.gov Identifier: NCT00388895    
Other Study ID Numbers: CSTI571BES02
02-0207 (nº AEMPS)
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: November 19, 2008
Last Verified: November 2008
Keywords provided by PETHEMA Foundation:
Acute lymphoblastic Leukemia
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action