An Examination of the Effects of Omitting Consolidation Therapy before Hematopoietic Stem Cell Transplantation in Patients with Acute Myeloid Leukemia

A Comparison of the Effect of Induction Chemotherapy(7+3) with or without Consolidation Chemotherapy(5+2) before Stem Cell Transplantation on Disease-free Survival for Acute Myeloid Leukemia (AML) in the First Remission in the Hematology, Oncology, and Stem Cell Transplantation Research Center

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014081818842N1

Enrollment

Registered

2014-10-30

Start date

2011-11-27

Completion date

Unknown

Last updated

2023-02-07

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

Conditions

Acute myeloblastic leukemia. Acute myeloblastic leukemia [AML]

Interventions

Intervention 1: The control group routinely receives consolidation chemotherapy(5+2 ) and undergoes hematopoietic stem cell transplantation at a maximum of six months after chemotherapy commenced. Int

Eligibility

Sex/Gender

All

Age

16 Years to 55 Years

Inclusion criteria

Inclusion criteria: -AML Patients from M0-M7 Based on FAB Criteria , Except M3 Subtype -Cooperative patients 16 to 65 years old Entering Complete Remission after Receiving a Maximum of 2 Courses of Induction Treatment (regimen 7+3)

Exclusion criteria

Exclusion criteria: Failure to obtain a signed consent form Presence of comorbidities Abnormal function of kidney, liver and heart Lack of good performance Leukemic involvement of the central nervous system Lack of HLA-identical donors between siblings

Design outcomes

Primary

Measure	Time frame
Overall survival. Timepoint: 12 months after hematopoietic stem cell transplantation (HSCT). Method of measurement: Follow-up care.	—

Secondary

Measure	Time frame
Disease-free survival (DFS). Timepoint: 12 months after hematopoietic stem cell transplantation (HSCT). Method of measurement: Follow-up practice to detect relapse.;Transplant-related mortality. Timepoint: 12 months after hematopoietic stem cell transplantation (HSCT). Method of measurement: Follow-up and monitoring patients at risk of transplant-related mortality.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hossein Kamranzadeh

Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci

dr.kamranzadeh@gmail.com+98 21 8490 2635

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026