Phase 2 Leukaemia Trial, Completed NCT00101647 Sponsor: Bristol-Myers Squibb Condition: Leukaemia
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 174 people in total — 13 who had stopped taking the drug imatinib because they could not tolerate its side effects (the "imatinib-intolerant" group), and 161 whose disease had stopped responding to imatinib (the "imatinib-resistant" group). The trial was measuring how participants' blood counts responded to the study treatment, using two main response categories: a "major haematologic response" (MaHR — meaning blood counts returned to near-normal levels) and an "overall haematologic response" (OHR — a broader category that also included a lesser degree of improvement). All 174 participants who started the trial also completed it. The reported data shows that, looking at MaHR, 9 out of 13 people in the imatinib-intolerant group and 103 out of 161 in the imatinib-resistant group met that measure. For the broader OHR category, the numbers were 12 out of 13 and 127 out of 161 respectively. Among those who achieved a MaHR, the trial also tracked how many had maintained that response without their disease getting worse over time (using a statistical method called Kaplan-Meier estimation, which estimates the proportion still in response at a set point in time). At 12 months, the reported figures were approximately 85.7% of MaHR responders in the imatinib-intolerant group and 78.3% in the imatinib-resistant group. At 24 months, a figure was only reported for the imatinib-resistant group: approximately 60.9%. For the broader OHR category, the reported proportions still in response at 12 months were around 69.8% in both groups, and at 24 months approximately 34.9% (imatinib-intolerant) and 51.2% (imatinib-resistant). The reported data also shows that the middle point in time (median) for reaching a MaHR was 84 days in the imatinib-intolerant group and 63 days in the imatinib-resistant group, while the median time to reaching the broader OHR was 34 days and 30 days respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 2 Leukaemia Trial, Completed

NCT00101647
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with a specific type of blood cancer called chronic myeloid leukemia (CML) in an "accelerated phase," confirmed by certain genetic markers (Philadelphia chromosome positive or BCR/ABL positive).
  • Your CML has stopped responding to the drug imatinib (also called Gleevec), or you are unable to tolerate its side effects.
  • You have previously taken imatinib at some point, though it does not need to be the most recent treatment you received.
  • You are a man or woman aged 18 or older.
  • Your liver is functioning well enough to participate (confirm with trial site).
  • Your kidneys are functioning well enough to participate (confirm with trial site).
  • If you are a woman who could become pregnant, you must be willing to use reliable birth control for the entire study, starting at least 1 month before and continuing for at least 3 months after the study ends.

Who may not be able to join:

  • You are currently pregnant or breastfeeding.
  • You are willing and eligible to have a stem cell or bone marrow transplant during the initial screening period.
  • You have a serious medical condition or active infection that is not under control and could interfere with treatment.
  • You have heart or blood vessel disease that is not well controlled.
  • You are currently taking medications that increase your risk of bleeding.
  • You are currently taking medications that affect your heart rhythm.
  • You have dementia or a condition that affects your thinking in a way that would prevent you from understanding and agreeing to participate in the study.
  • You have a history of significant bleeding problems unrelated to your CML diagnosis.
  • You have another cancer that cannot be cured, in addition to CML.
  • You have problems with organ function or digestion that would prevent you from receiving the study treatment (confirm with trial site).
  • You have previously been treated with the drug dasatinib (also known as BMS-354825).
  • You are currently in prison or are being held involuntarily in a facility for psychiatric or physical health treatment.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Bristol-Myers Squibb, Bristol-Myers Squibb

Australian sites

Local Institution, St Leonards, New South Wales
Local Institution, South Brisbane, Queensland
Local Institution, East Melbourne, Victoria
Local Institution, Parkville, Victoria
Local Institution, Wien,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 December 2004
Est. completion
1 August 2006

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇩🇰 Denmark 🇫🇮 Finland 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇮🇹 Italy 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇪 Peru 🇵🇭 Philippines 🇸🇬 Singapore 🇰🇷 South Korea 🇸🇪 Sweden 🇨🇭 Switzerland 🇹🇼 Taiwan 🇹🇭 Thailand 🇬🇧 United Kingdom 🇺🇸 United States

5 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Major and Overall Hematologic Response (MaHR and OHR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov