HCT Versus CT in Elderly 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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766779

Enrollment

126

Registered

2008-10-06

Start date

2010-01-31

Completion date

2020-12-31

Last updated

2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia

Keywords

hematopoietic cell transplantation, Acute Myeloid Leukemia, first Complete Remission

Brief 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.

Detailed description

The majority of patients with acute myelogenous leukaemia (AML) enter complete remission following induction therapy, but relapse despite consolidation and maintenance therapy. In response, post-remission treatment has been progressively intensified and results improved either by high-dose post-remission therapy with autologous hematopoietic cell transplantation (HCT) or by allogeneic HCT, which has the highest curative potential for patients with AML. Given the toxicity of dose intensification and of allogeneic HCT, however, only younger patients profit from this treatment approach

Interventions

PROCEDUREhematopoietic cell transplantation

low dose total body irradiation-based conditioning and hematopoietic cell transplantation from related and unrelated donors

DRUGNon-Transplant treatment approach for consolidation

Patients will receive the treatment that would be otherwise applied at the local institution. The consolidation or maintenance therapy is according to the study group protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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 criteria

* 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

Design outcomes

Primary

Measure	Time frame
To evaluate Leukaemia Free Survival (LFS) after allo HCT in AML/RAEB in complete remission using matched or unrelated donors in comparison to conventional chemotherapy	5 years

Secondary

Measure	Time frame
To evaluate overall survival, relapse, Treatment Related Mortality (TRM) and complications after HCT	5 Years

Countries

Australia, Austria, Belgium, France, Germany, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026