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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 (RICMAC)


Phase 3
18 Years
65 Years
Open (Enrolling)
Both
Myelodysplastic Syndromes, 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 (RICMAC)


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 anti¬gen-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:

Universitätsklinikum Hamburg-Eppendorf

Authority:

Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

2005-002011-24

NCT ID:

NCT01203228

Start Date:

May 2004

Completion Date:

December 2014

Related Keywords:

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

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