Phase 2 Leukaemia Trial, Recruiting NCT01409161 Sponsor: M.D. Anderson Cancer Center Condition: Leukaemia
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Phase 2 Leukaemia Trial, Recruiting

NCT01409161
Recruiting Phase 2

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:

  • People who have been diagnosed with a specific type of blood cancer called APL (Acute Promyelocytic Leukaemia), confirmed by specific genetic tests showing a particular gene change called PML-RAR-alpha
  • People who are able to understand the study and are willing to sign a written consent form showing they understand this is a research study
  • People who have already started urgent APL treatment (such as ATRA, ATO, and/or one dose of idarubicin) before enrolling, as emergency treatment may have been needed right away
  • Women who could become pregnant must have a negative pregnancy test at the start of the study, and another negative pregnancy test within 48 hours before taking the study drug
  • All participants who are sexually active and could father or become pregnant must agree to use 2 effective forms of contraception throughout the entire study

Who may not be able to join:

  • People whose heart electrical activity test (ECG) shows a specific measurement called QTcF that is longer than 480 milliseconds, indicating a possible heart rhythm concern
  • People with kidney function test results more than 2.5 times above the normal range, unless the treating doctor determines this is caused by the leukaemia itself, a condition called haemolysis, or Gilbert's disease
  • People with liver test results (total bilirubin) at 2 times or more above the normal range, unless the treating doctor determines this is caused by the leukaemia itself, haemolysis, or Gilbert's disease
  • People with elevated liver enzyme levels (ALT/AST) more than 3 times above the normal range, unless the treating doctor determines this is caused by the leukaemia itself, haemolysis, or Gilbert's disease

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 22 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: Farhad Ravandi-Kashani, M.D. Anderson Cancer Center

Phone: 713-745-0394

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
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
5 October 2011
Est. completion
18 December 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Event free survival

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: 22 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