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Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Myelodysplastic Syndrome, Secondary Acute Myeloid Leukemia

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Trial Information

Dose-Reduced Versus Standard Conditioning Followed by Allogeneic Stem Cell Transplantation in Patients With MDS or sAML: A Randomised Phase III Study


Inclusion Criteria:



- Disease: cytologically proven

- primary or therapy related myelodysplastic syndrome (MDS) either as

- refractory anaemia (RA) according FAB or RA with or without dysplasia
according WHO

- refractory anaemia with ringsideroblasts (RARS) according FAB or RARS with
or without dysplasia according WHO

- refractory anaemia with excess of blasts (RAEB) according FAB or RAEB I or
RAEB II according WHO

- refractory anaemia with excess of blast in transformation (RAEB-T)
according FAB

- CMML (dysplastic type) according WHO

- or secondary acute myeloid leukaemia (sAML)

- Blast count <20 percent in bone marrow with or without chemotherapy at time of
transplantation

- Patient eligible for standard and dose-reduced conditioning as per local guideline

- Patient age 18-60 years if donor is a HLA-matched UNRELATED donor (HLA-A, HLA-B,
HLA-DRB1 and HLA-DQB1) (one mismatch allowed)

- Patient age 18-65 years if donor is a HLA-matched RELATED donor (HLA-A, HLA-B,
HLA-DRB1 and HLA-DQB1)(one antigen-mismatch allowed)

- no major organ dysfunction

- written informed consent of the patient

Exclusion Criteria:

- Blasts >20% in bone marrow at time of transplantation

- no written informed consent

- central nervous involvement

- Severe irreversible renal, hepatic, pulmonary or cardiac disease, such as

- total bilirubin, SGPT or SGOT > 2 times upper the normal level

- Left ventricular ejection fraction <30%

- creatinine clearance <30 ml/min

- DLCO <35% and/or receiving supplementary continuous oxygen

- Positive serology for HIV

- pregnant or lactating women

- patients with a life-expectancy of less than six months because of another
debilitating disease

- serious psychiatric or psychological disorders

- invasive fungal infection at time of registration

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

non relapse mortality

Outcome Time Frame:

every 6 months for safety and in the final analysis at one year after allogeneic stem cell transplantation

Safety Issue:

Yes

Principal Investigator

Nicolaus Kröger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University Medical Center Hamburg-Eppendorf, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

RICMAC

NCT ID:

NCT00682396

Start Date:

May 2004

Completion Date:

May 2013

Related Keywords:

  • Myelodysplastic Syndrome
  • Secondary Acute Myeloid Leukemia
  • Reduced Intensity conditioning
  • Myeloablative conditioning
  • Allogeneic stem cell transplantation
  • MUD
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

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