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Closed (no longer recruiting)Last updated: 1 February 2024

This phase III trial is trying to determine how safe and effective the drug Uproleselan is, when given in combination with chemotherapy, in the treatment of Acute Myeloid Leukaemia that has got worse or not responded to prior therapyA Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Clinical summary

Summary

Eligible participants will be randomised to receive Uproleselan or a placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI).

Conditions

This trial is treating patients with Acute Myeloid Leukaemia.

Cancer

Blood Cancers Haematological

Age

People18 - 75

Phase

III

More information

Trial Identifiers

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Trial sponsor

GlycoMimetics Incorporated

Scientific Title

A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Eligibility

Inclusion

  • ≥18 years and ≤75 years in age
  • Patients with relapsed or refractory AML
  • No more than one prior stem cell transplant
  • Has not received the chemotherapy regimen to be used for induction on this trial
  • Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

Exclusion

  • Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
  • Active signs or symptoms of CNS involvement by malignancy.
  • Stem cell transplantation ≤4 months prior to dosing.
  • Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
  • Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  • Inadequate organ function.
  • Abnormal liver function.
  • Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  • Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  • Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  • Clinically significant cardiovascular disease.
  • Major surgery within 4 weeks of dosing.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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