HCT Versus CT in Elderly AML

European Society for Blood and Marrow Transplantation

Status and phase: Terminated; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Non-Transplant treatment approach for consolidation; Procedure: hematopoietic cell transplantation

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT00766779

2007-003514-34

EBMT-ALWP01/2008

Details and patient eligibility

About

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.

Full 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

Enrollment: 126 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

126 participants in 2 patient groups

Transplant Arm

Experimental group

Description:

Hematopoietic cell transplantation after Reduced Intensity Conditioning

Treatment:

Procedure: hematopoietic cell transplantation

Conventional Chemotherapy

Active Comparator group

Description:

The non-transplant treatment approach for consolidation

Treatment:

Drug: Non-Transplant treatment approach for consolidation