Phase 3 Trial for AML Patients in CR2 Comparing 8Gy TBI /Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

Randomized Phase 3 Trial for Patients With AML in CR2 Comparing Total Body Irradiation (TBI) With 8Gy/Fludarabine to Conditioning With TBI 12Gy/Cyclophosphamide

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125606

Enrollment

Registered

2005-08-01

Start date

2004-10-31

Completion date

2011-07-31

Last updated

2012-12-18

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

Conditions

Acute Myeloid Leukemia

Keywords

AML, allogeneic HSCT, reduced intensity conditioning, randomized trail

Brief summary

For patients with acute myeloid leukemia (AML), allogeneic hematopoetic stem cell transplantation (HSCT) is one of the most potent treatment options currently available. In order to overcome the high risk of fatal treatment-related complications, reduced intensity and nonmyeloablative conditioning regimens for allogeneic HSCT are currently being explored in various hematological malignancies including AML. At least for allogeneic HSCT in AML, the optimal dose-intensity of preparative regimens for disease control at an acceptable rate of treatment-related lethal complications has not been determined. The investigators, therefore, evaluated reduced intensity myeloablative conditioning with 8 Gy TBI and fludarabine in AML patients considered ineligible for conventional conditioning in a phase 2 trial (data published in BLOOD by Stelljes et al., 2005). The results suggest that with 8 Gy TBI/fludarabine, conditioning related and unrelated donor transplants can be performed in AML patients in first or second complete remission (CR) with a remarkably low 2-year non relapse mortality (NRM) and satisfactory disease control. Based on these data a randomized phase 3 trial for patients with AML in CR≥2 is currently being conducted by the Cooperative German Transplant Study Group comparing TBI 8 Gy/fludarabine to conventionally dosed conditioning with TBI 12 Gy/cyclophosphamide.

Interventions

PROCEDUREconditioning for allogeneic HSCT

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Patients with AML in second complete remission * HLA-identical related (HLA \* A, B, and DR) or HLA-compatible unrelated donor with maximum of one Ag mismatch * Ages 18-60 years * Written informed consent from the patient * Written informed consent from the donor * No major organ dysfunction

Exclusion criteria

* Cardiac failure (New York Heart Association \[NYHA\] grade II-IV) * Renal failure (creatinine \> 2.0 mg/dl) * Hepatic failure (total bilirubin \> 3 mg/dl) * Severe neurological/psychiatric disorder * Previous allogeneic HSCT * Contra-indications for used drugs * HIV infection * Non-compliance to processing of personal data according to the protocol

Design outcomes

Primary

Measure	Time frame
treatment related mortality	—

Secondary

Measure	Time frame
event free survival	—
overall survival	—
cumulative incidence of acute and chronic graft-versus-host disease (GvHD)	—
activity index (ECOG)	—
organ function	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026