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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:
ClinicalTrials.gov Identifier:
NCT00253513
First Posted: November 15, 2005
Last Update Posted: June 1, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
medac GmbH
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
Results First Submitted: November 16, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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 
[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.
Cytogenetic risk group [1] 
[Units: Participants]
 
Good   16 
Intermediate   8 
Poor   36 
[1] 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
Hematopoietic Cell Transplantation Comorbidity Index (HCT CI) [1] 
[Units: Participants]
 
 13 
1-2   19 
>=3   28 
[1] Risk of mortality after allograft (0 is lower risk, >=3 is higher risk)
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 


  Outcome Measures
  Show All Outcome Measures

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


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



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 ( Other Identifier: OHSU IRB )
First Submitted: November 11, 2005
First Posted: November 15, 2005
Results First Submitted: November 16, 2010
Results First Posted: February 11, 2011
Last Update Posted: June 1, 2012