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Completed

NCT Number: NCT00388895

Glivec in Ph Positive Lymphoblastic Leukemia

% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment

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Key information

Age range

Up to 65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital General de Alicante, Alicante, Spain

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About this study

Pilot phase II clinical trial, prospective, multicentric and opened

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Chemotherapy

Drug

Glivec

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

PETHEMA Foundation

Other

Registry information

Official study title

Positive Ph Acute Lymphoblastic Leucemia With Intensive Induction Chemotherapy and Glivec, Before and After the Hematopoetic Progenitor Transplant

Important dates

Study start
2002
Primary completion
2006
Study completion
2007
First posted
Oct 17, 2006
Registry last updated
Nov 19, 2008

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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