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
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
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
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  
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 ]

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


  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
No text entered.  


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