Treosulfan and Fludarabine in Treating Younger Patients Who Are Undergoing a Donor Stem Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome

This study has been completed.

Sponsor:

Collaborators:

medac GmbH

National Cancer Institute (NCI)

Information provided by (Responsible Party):

OHSU Knight Cancer Institute

ClinicalTrials.gov Identifier:

NCT00253513

First received: November 11, 2005

Last updated: May 24, 2012

Last verified: February 2011

History of Changes

Results First Received: November 16, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Leukemia Myelodysplastic Syndromes
Interventions:	Drug: fludarabine Drug: treosulfan Procedure: allogeneic blood or bone marrow transplantation

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited at OHSU Knight Cancer Institute clinics in Portland, Oregon and Fred Hutchinson Cancer Research Center or University of Washington Medical Center clinics, Seattle, Washington.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Treosulfan and Fludarabine Conditioning	Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

Participant Flow: Overall Study

	Treosulfan and Fludarabine Conditioning
STARTED	60
COMPLETED	60
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
Treosulfan and Fludarabine Conditioning	Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies

Baseline Measures

	Treosulfan and Fludarabine Conditioning
Number of Participants [units: participants]	60
Age, Customized [units: Participants]
< 21 years	10
Between 21 - 50 years	31
Between 50 - 60 years	19
Gender [units: participants]
Female	36
Male	24
Region of Enrollment [units: participants]
United States	60
Disease status at transplantation [units: Participants]
Acute Lymphoblastic Leukemia(ALL)2nd/3rd remission	3
Acute Myelogenous Leukemia(AML)1st remission	26
AML, 2nd or greater remission.	10
AML, relapsed or primary refractory	8
Myelodysplastic Syndrome(MDS): Refract. Anemia(RA)	6
MDS: RA with excess blasts in transformation	7
Disease risk group ^[1] [units: Participants]
Low - AML/ALL in 1st rem., MDS with IPSS=0	26
Standard (ALL or AML in 2nd or greater rem.)	22
High -relapsed/refract. ALL/AML/MDS w/ IPSS>=2.5	12
Cytogenetic risk group ^[2] [units: Participants]
Good	16
Intermediate	8
Poor	36
Hematopoietic Cell Transplantation Comorbidity Index (HCT CI) ^[3] [units: Participants]
0	13
1-2	19
>=3	28
Donor type [units: participants]
HLA (human leukocyte antigen) -identical sibling	30
HLA-matched unrelated donor	30
Stem cell source [units: participants]
Bone marrow	7
Filgrastim-mobilized PBPC	53

[1]	Low-risk disease: AML or ALL in first remission, MDS with IPSS (International Prognosis Scoring System)=0; standard risk: ALL or AML in second or greater remission, MDS with IPSS 0.5-2; high risk: relapsed/refractory ALL or AML, MDS with IPSS>=2.5.
[2]	Good risk cytogenetics: t(8;21), t(15;17), or inversion 16 for AML, hyperdiploidy for ALL, -Y, del(5q), del(20q), or normal for MDS; poor risk: 11q23 abnormalities, monosomy 7, monosomy 5, deletion 5q, or abnormalities of 3q for AML, t(9;22) or extreme hypodiploidy for ALL, chromosome 7 abnormalities in MDS,$3 chromosome abnormalities for any disease type; Intermediate risk: all others
[3]	Risk of mortality after allograft (0 is lower risk, >=3 is higher risk)

Outcome Measures

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1. Primary:

Number of Patients Experiencing Regimen-related Toxicity Events in Study Population [ Time Frame: 34 days and 2 years ]

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2. Primary:

Number of Patients Experiencing Graft Failure [ Time Frame: 42 days ]

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3. Primary:

Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only) [ Time Frame: 200 days ]

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4. Secondary:

Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival. [ Time Frame: One year ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Eneida Nemecek, MD
Organization: OHSU Knight Cancer Institute
phone: (503) 494-0829
e-mail: nemeceke@ohsu.edu

No publications provided

Responsible Party:	OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:	NCT00253513 History of Changes
Other Study ID Numbers:	CDR0000445306, FHCRC-1931.00, MEDAC-FHCRC-1931.00, OHSU-HEM-05107-LM, 1765
Study First Received:	November 11, 2005
Results First Received:	November 16, 2010
Last Updated:	May 24, 2012
Health Authority:	United States: Food and Drug Administration

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