CompletedPhase 2

An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast Crisis

United States, France, Germany260 participantsStarted 1999-07-26

Plain-language summary

This extension II study allowed for further follow-up of the disease under treatment with imatinib mesylate and allow the participants to continue to receive imatinib mesylate.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. ≥ 30% blast in peripheral blood and /or bone marrow
✓. by flow cytometry criteria

Exclusion criteria

✕. Participants with an eastern cooperative oncology group (ECOG) performance status score ≥ 3.
✕. Participants previously treated for blast crisis were not to have received any of the following with respect to Day 1 of the study: busulfan within six weeks, interferon-alpha within 48-hours, hydroxyurea within 24-hours, homoharringtonine within 14 days, low-dose, moderate dose or high dose cytosine arabinoside within 7, 14 and 28 days respectively, anthracyclines, mitoxantrone, or etoposide within 21 days.
✕. Participants receiving any hematopoietic stem cell transplantation within six weeks of Day 1.
✕. Participants receiving any other investigational agents within 28 days of Day 1.
✕. Participants with Grade 3/4 cardiac disease or any other serious concurrent medical conditions.

What they're measuring

Overall Survival

Timeframe: From first dose until death of the patient, up to 14 years.

Overall Survival (by Month)

Timeframe: From first dose until death of the patient, up to 14 years.

Trial details

NCT IDNCT00171158

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-04

Results submitted2021-05-07

View on ClinicalTrials.gov More Philadelphia Chromosome Positive CML trials