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Treosulfan-based Conditioning for Transplantation in AML/MDS

NCT ID: NCT00491634

Last Updated: 2015-12-02

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2014-06-30

Brief Summary

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The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan, will reduce toxicity after allogeneic transplantation while improving myeloablation and and disease control in patients with AML and MDS not eligible for standard transplantation.

Detailed Description

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Conditions

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Acute Myeloid Leukemia Myelodysplastic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

treosulfan

Group Type EXPERIMENTAL

treosulfan

Intervention Type DRUG

12 g/m2 x 3 days

Treosulfan

Intervention Type DRUG

12 g/m2 x 3

Interventions

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treosulfan

12 g/m2 x 3 days

Intervention Type DRUG

Treosulfan

12 g/m2 x 3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age less than physiologic 68 years.
2. Patients with AML and MDS not eligible for standard TBI- or Busulfan-based myeloablative conditioning due to age, concurrent medical condition, or extensive prior therapy (e.g. age \> 55 years for HLA-matched sibling transplants or \> 50 for matched unrelated donor transplants, prior / concomitant pulmonary, liver, or other organ complications).
3. This study will only include patients with chemo-refractory disease or previously untreated active disease.

A. acute myeloid leukemias (AML) according to WHO classification (\> 20% myeloblasts in peripheral blood or bone marrow at diagnosis) in induction failure, PR, untreated or chemo-refractory relapse. Patients must have \> 10% marrow blasts at the time of transplantation.

B. myelodysplastic syndromes (MDS) according to WHO classification (\< 20% myeloblasts in peripheral blood and bone marrow at diagnosis), indicated for allogeneic transplantation:

\- refractory anaemia with excess blasts (RAEB-1 and RAEB-2) with no prior therapy
4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient -

Exclusion Criteria

1. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit
2. Creatinine \> 2.0 mg/dl
3. ECOG-Performance status \> 2
4. Uncontrolled infection
5. Pregnancy or lactation
6. Abnormal lung diffusion capacity (DLCO \< 40% predicted)
7. Severe cardiovascular disease
8. CNS disease involvement
9. Pleural effusion or ascites \> 1 liter
10. Known hypersensitivity to fludarabine or treosulfan
11. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate -
Minimum Eligible Age

18 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Avichai Shimoni MD

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Avichai Shimoni MD

Dr. Avichai Shimoni

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arnon Nagler, MD

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

References

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Kroger N, Shimoni A, Zabelina T, Schieder H, Panse J, Ayuk F, Wolschke C, Renges H, Dahlke J, Atanackovic D, Nagler A, Zander A. Reduced-toxicity conditioning with treosulfan, fludarabine and ATG as preparative regimen for allogeneic stem cell transplantation (alloSCT) in elderly patients with secondary acute myeloid leukemia (sAML) or myelodysplastic syndrome (MDS). Bone Marrow Transplant. 2006 Feb;37(4):339-44. doi: 10.1038/sj.bmt.1705259.

Reference Type BACKGROUND
PMID: 16415898 (View on PubMed)

Other Identifiers

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SHEBA-07-3116-AN-CTIL

Identifier Type: -

Identifier Source: org_study_id