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Trial record 83 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

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

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ClinicalTrials.gov Identifier: NCT00253513
Recruitment Status : Completed
First Posted : November 15, 2005
Results First Posted : February 11, 2011
Last Update Posted : June 1, 2012
Sponsor:
Collaborators:
medac GmbH
National Cancer Institute (NCI)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

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
Enrollment 60
Recruitment Details 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  
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description 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
Period Title: Overall Study
Started 60
Completed 60
Not Completed 0
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description 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
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
< 21 years 10
Between 21 - 50 years 31
Between 50 - 60 years 19
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
36
  60.0%
Male
24
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
Disease status at transplantation  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 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]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
Good 16
Intermediate 8
Poor 36
[1]
Measure Description: 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] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
0 13
1-2 19
>=3 28
[1]
Measure Description: Risk of mortality after allograft (0 is lower risk, >=3 is higher risk)
Donor type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
HLA (human leukocyte antigen) -identical sibling 30
HLA-matched unrelated donor 30
Stem cell source  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 60 participants
Bone marrow 7
Filgrastim-mobilized PBPC 53
1.Primary Outcome
Title Number of Patients Experiencing Regimen-related Toxicity Events in Study Population
Hide Description Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal
Time Frame 34 days and 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Severe Regimen Related Toxicity (RRT) 2
Nonrelapse mortality at 2 years 5
2.Primary Outcome
Title Number of Patients Experiencing Graft Failure
Hide Description Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.
Time Frame 42 days
Hide Outcome Measure Data
Hide Analysis Population Description
For graft failure 2 of the 60 patients were not evaluable because they exeperienced another event (relapsed) before they could be evaluable for graft failure.
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 58
Measure Type: Number
Unit of Measure: participants
acute graft vs. host disease (aGVHD) 36
chronic graft vs. host disease (cGVHD) 31
3.Primary Outcome
Title Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)
Hide Description NRM (Non relapse mortality) - death not attributed to the primary cancer.
Time Frame 200 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent of participants
5
(0 to 10.5)
4.Secondary Outcome
Title Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.
Hide Description [Not Specified]
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
58
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treosulfan and Fludarabine Conditioning
Hide Arm/Group Description 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
All-Cause Mortality
Treosulfan and Fludarabine Conditioning
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treosulfan and Fludarabine Conditioning
Affected / at Risk (%) # Events
Total   5/60 (8.33%)    
Blood and lymphatic system disorders   
Death - intracranial hemmorrage  1/60 (1.67%)  1
Immune system disorders   
Death - cGVHD  2/60 (3.33%)  2
Infections and infestations   
Death - fungal infection  2/60 (3.33%)  2
Respiratory, thoracic and mediastinal disorders   
Grade 4 mucositis  1/60 (1.67%)  1
1
Term from vocabulary, CTCAE v2.0
2
Term from vocabulary, NCI-CTCAE v 2.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treosulfan and Fludarabine Conditioning
Affected / at Risk (%) # Events
Total   0/60 (0.00%)    
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
Layout table for Results Point of Contact information
Name/Title: Eneida Nemecek, MD
Organization: OHSU Knight Cancer Institute
Phone: (503) 494-0829
EMail: nemeceke@ohsu.edu
Layout table for additonal information
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