Dose-reduced Versus Standard Conditioning in MDS/sAML

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2015-02-28

Brief Summary

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In this trial dose reduced conditioning is compared to standard conditioning followed by allogeneic stem cell transplantation from related or unrelated donors in patients with MDS or secondary AML.

Conditioning is the very high dose chemotherapy treatment that is given in the days before the stem cell transplant.

The hypothesis is that a dose reduced conditioning will reduce the non-relapse mortality from 40% to 20% at one year after allogeneic stem cell transplantation.

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Detailed Description

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Conditions

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Myelodysplastic Syndromes Secondary Acute Myeloid Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Myeloablative conditioning

Group Type ACTIVE_COMPARATOR

Myeloablative conditioning

Intervention Type OTHER

Busilvex®:

12.8 mg/kg IBW i. v.; day -9: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -8: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)

or (if i.v.-application is not available):

Busulfan:

16.0 mg/kg BW p. o.; day -9: 4.0 mg/kg BW day -8: 4.0 mg/kg BW day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW

plus:

Cyclophosphamide:

120 mg/kg BW i. v.; day -4: 60 mg/kg BW day -3: 60 mg/kg BW

B

Reduced Intensity Conditioning

Group Type EXPERIMENTAL

Reduced Intensity Conditioning

Intervention Type OTHER

Busilvex®:

6.4 mg/kg IBW i. v. day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)

or (if i.v.-application is not available)

Busulfan:

8.0 mg/kg BW p. o.: day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW

plus:

Fludarabine:

5 x 30 mg/m² BS i. v.: day -7: 30 mg/m² BS day -6: 30 mg/m² BS day -5: 30 mg/m² BS day -4: 30 mg/m² BS day -3: 30 mg/m² BS

Interventions

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Reduced Intensity Conditioning

Busilvex®:

6.4 mg/kg IBW i. v. day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)

or (if i.v.-application is not available)

Busulfan:

8.0 mg/kg BW p. o.: day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW

plus:

Fludarabine:

5 x 30 mg/m² BS i. v.: day -7: 30 mg/m² BS day -6: 30 mg/m² BS day -5: 30 mg/m² BS day -4: 30 mg/m² BS day -3: 30 mg/m² BS

Intervention Type OTHER

Myeloablative conditioning

Busilvex®:

12.8 mg/kg IBW i. v.; day -9: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -8: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)

or (if i.v.-application is not available):

Busulfan:

16.0 mg/kg BW p. o.; day -9: 4.0 mg/kg BW day -8: 4.0 mg/kg BW day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW

plus:

Cyclophosphamide:

120 mg/kg BW i. v.; day -4: 60 mg/kg BW day -3: 60 mg/kg BW

Intervention Type OTHER

Other Intervention Names

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Myleran Sulphabutin Busulphan Leucosulfan Myeloleukon Citosulfan Mielevcin Milecitan Fludara Beneflur Fludura FAMP 2-Fluoro-ara-AMP Myleran Sulphabutin Busulphan Leucosulfan Myeloleukon Citosulfan Mielevcin Milecitan cyclophosphamide Procytox Cytoxan Cyclophosphan Cytophosphan Claphene Cyclostin Endoxan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No