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CompletedLast updated: 7 February 2024

HCT versus CT: This phase III trial is comparing two types of consolidation therapy (standard chemotherapy and hematopoietic cell transplantation) for patients in complete remission for Acute Myeloid Leukaemia (AML)Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission (Other ID's: 2007-003514-34, EBMT-ALWP01/2008)

Clinical summary

Summary

A study comparing conventional chemotherapy to low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors as consolidation therapy for older Patients with AML in first Complete Remission.

Conditions

This trial is treating patients with Acute Myeloid Leukaemia.

Cancer

Blood Cancers Haematological

Age

People60 - 75

Phase

III

Trial Acronym

HCT versus CT

More information

Trial Identifiers

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Trial sponsor

Cancer Trials Australia (CTA)

Scientific Title

Randomized Phase III Study Comparing Conventional Chemotherapy to Low Dose Total Body Irradiation-Based Conditioning and HCT From Related and Unrelated Donors as Consolidation Therapy for Older Patients With AML in 1st Complete Remission (Other ID's: 2007-003514-34, EBMT-ALWP01/2008)

Eligibility

Inclusion

  • Age ≥ 60years and ≤ 75 years
  • primary or secondary AML as defined by WHO or refractory anemia with excess of blasts (RAEB)
  • First complete remission following one or two cycles of induction chemotherapy
  • Chemotherapy was administered according to current participating cooperative group protocols
  • Karnofsky score ≥ 70
  • Written informed consent

Exclusion

  • AML FAB M3
  • HIV positivity

  • Participation in another clinical trial without prior consent of the coordinating investigator, patients may exceptionally take part in a further study only if

    • The second study exclusively concerns induction therapy
    • Consolidation cycle one and two are given according to the accredited study group policy
    • No investigational drugs are used post registration for the HCT vs CT in eldery AML study.
    • Documentation for the HCT vs CT in eldery AML study is not compromised. Second hand data from foreign study is not accepted

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

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The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

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Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.