Know Cancer

or
forgot password

Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission


Phase 3
18 Years
60 Years
Not Enrolling
Both
Acute Myeloid Leukemia

Thank you

Trial Information

Randomized Phase III Comparison of 12 Gy TBI and Cyclophosphamide 120 mg/kg With Fludarabine 120 mg/Sqm and 8 Gy TBI Before Allogeneic Transplantation in Patients With Acute Myeloid Leukemia in First Remission


Transplant-related deaths because of extramedullary toxicity and graft-versus host disease
remain the major causes for treatment-failure in patients with AMl receiving allogeneic
hematopoietic stem cell transplantation.

In phase II study, M . Stelljes and coworkers could show, that a reduced dose of total-body-
irradiation and fludarabine can be safely used in patients with AML at various disease
stages. The best results could be achieved in patients who had been in complete remission by
the time of inclusion.

Therefore this prospective trial was initiated to compare the new conditioning regimen with
the standard regimen of 12 Gy TBI/Cyclophosphamide 120 mg/kg in patients ith AML in first
remission.

After having achieved complete remission, and giving informed consent, patients are
stratified according to marrow cytogenetics, age and type of induction therapy and
subsequently randomized to receive on of the mentioned conditioning therapies.

The primary end-point will be non-relapse mortality. The hypothesis would be, that the
one-year mortality can be reduced from 25 to 15%. Given a power of 0.8 and a first-error of
5%, 252 patients will have to be randomized.

Secondary endpoints include:

3 year overall-and disease-free survival Rate of grade II-IV acute GvHD Rate of grade 3-4
extramedullary toxicity


Inclusion Criteria:



- Diagnosis of acute myeloid leukemia in first remission

- Standard-or high-risk marrow cytogenetics

- HLA-matched related or unrelated donor available (in case of high-risk disease)

- Age 18 to 60

- Informed consent

- Consent of donor to donate peripheral blood stem cells

- sufficient liver function (elevation of transferases < 2.5 x upper limit)

Exclusion Criteria:

- AML with t(5;17)

- AML with t((8;21)

- clinically relevant heart failure (NYHA II-IV)

- Renal failure (creatinine > 200 µg/ml)

- Liver function failure (bilirubin > 3 mg/dl)

- Concomitant Neurological or psychiatric disease

- Contraindications to receive prescribed study medication

- HIV infection

- Pregnancy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Treatment-related mortality at 12 months after transplantation

Outcome Description:

Proportion of patients dying without prior relapse

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

Gerhard Ehninger, MD

Investigator Role:

Study Director

Investigator Affiliation:

Director of Med. Klink und Poliklinik I, Technical University Dresden

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

9005-2003

NCT ID:

NCT00150878

Start Date:

December 2003

Completion Date:

December 2010

Related Keywords:

  • Acute Myeloid Leukemia
  • Reduced-intensity conditioning
  • Fludarabine
  • Acute myeloid Leukemia
  • Treatment-related mortality
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location