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Trial record 88 of 126 for:    "Acute Leukemia" | "Antimetabolites, Antineoplastic"

Fludarabine Phosphate and Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia or Chronic Myelogenous Leukemia That Has Responded to Treatment With Imatinib Mesylate, Dasatinib, or Nilotinib

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ClinicalTrials.gov Identifier: NCT00036738
Recruitment Status : Active, not recruiting
First Posted : January 27, 2003
Results First Posted : August 22, 2017
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
George Georges, Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adult Acute Lymphoblastic Leukemia in Remission
Adult B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Blastic Phase
Childhood Acute Lymphoblastic Leukemia in Remission
Childhood B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1
Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Chronic Phase of Disease
Recurrent Adult Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Disease
Interventions Drug: Cyclosporine
Drug: Dasatinib
Drug: Fludarabine Phosphate
Drug: Imatinib Mesylate
Drug: Mycophenolate Mofetil
Drug: Nilotinib
Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Procedure: Peripheral Blood Stem Cell Transplantation
Biological: Therapeutic Allogeneic Lymphocytes
Radiation: Total-Body Irradiation
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Period Title: Overall Study
Started 28
Completed 28
Not Completed 0
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Baseline Participants 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  92.9%
>=65 years
2
   7.1%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 28 participants
57.6
(33.8 to 69.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants
Female
9
  32.1%
Male
19
  67.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants
28
1.Primary Outcome
Title Relapse Free Survival
Hide Description Number of patients with relapsed disease within 1 Year post-transplant. Relapse is defined as the detection of > 5% blasts after a documented complete remission.
Time Frame Assessed up to 1 year
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[Not Specified]
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.7%
2.Secondary Outcome
Title Leukemia-free Survival
Hide Description Number of patients surviving in CR up to five years post-transplant.
Time Frame Assessed up to 5 years
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[Not Specified]
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
6 Months
19
  67.9%
1 Year
17
  60.7%
2 Years
13
  46.4%
3 Years
11
  39.3%
4 Years
11
  39.3%
5 Years
10
  35.7%
3.Secondary Outcome
Title Overall Survival
Hide Description Number of patients surviving up to five years post-transplant.
Time Frame Assessed up to 5 years
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[Not Specified]
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
6 Months
26
  92.9%
1 Year
24
  85.7%
2 Years
19
  67.9%
3 Years
17
  60.7%
4 Years
16
  57.1%
5 Years
13
  46.4%
4.Secondary Outcome
Title Transplant-related Mortality
Hide Description Number of patients with TRM within 100 days post-transplant.
Time Frame At day 100
Hide Outcome Measure Data
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[Not Specified]
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.6%
5.Secondary Outcome
Title Transplant-related Mortality
Hide Description Number of patients with TRM within one year post-transplant.
Time Frame At 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

Overall Number of Participants Analyzed 28
Measure Type: Count of Participants
Unit of Measure: Participants
3
  10.7%
Time Frame AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Allogeneic Nonmyeloablative HSCT)
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Cyclosporine: Given IV or PO

Dasatinib: Given PO

Fludarabine Phosphate: Given IV

Imatinib Mesylate: Given PO

Mycophenolate Mofetil: Given PO

Nilotinib: Given PO

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo nonmyeloablative allogeneic PBSC transplantation

Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplantation

Therapeutic Allogeneic Lymphocytes: Given IV

Total-Body Irradiation: Undergo TBI

All-Cause Mortality
Treatment (Allogeneic Nonmyeloablative HSCT)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Allogeneic Nonmyeloablative HSCT)
Affected / at Risk (%) # Events
Total   2/28 (7.14%)    
Investigations   
Blood bilirubin increased   1/28 (3.57%)  1
Nervous system disorders   
Encephalopathy   1/28 (3.57%)  1
Intracranial hemorrhage   1/28 (3.57%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Allogeneic Nonmyeloablative HSCT)
Affected / at Risk (%) # Events
Total   8/28 (28.57%)    
Blood and lymphatic system disorders   
Febrile neutropenia   1/28 (3.57%)  1
Cardiac disorders   
Atrial flutter   1/28 (3.57%)  1
Gastrointestinal disorders   
Diarrhea   1/28 (3.57%)  1
Immune system disorders   
Anaphylaxis   1/28 (3.57%)  1
Investigations   
Blood bilirubin increased   3/28 (10.71%)  3
Nervous system disorders   
Transient ischemic attacks   1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders   
Bronchopulmonary hemorrhage   1/28 (3.57%)  1
Pneumonitis   1/28 (3.57%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. George Georges
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-6886
EMail: ggeorges@fredhutch.org
Layout table for additonal information
Responsible Party: George Georges, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00036738     History of Changes
Other Study ID Numbers: 1581.00
NCI-2010-00131 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
1581.00 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P01CA078902 ( U.S. NIH Grant/Contract )
P30CA015704 ( U.S. NIH Grant/Contract )
First Submitted: May 13, 2002
First Posted: January 27, 2003
Results First Submitted: July 24, 2017
Results First Posted: August 22, 2017
Last Update Posted: July 9, 2019