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Trial record 91 of 106 for:    PHENYTOIN

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer (Bu Flu TBI)

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ClinicalTrials.gov Identifier: NCT00245037
Recruitment Status : Completed
First Posted : October 27, 2005
Results First Posted : July 2, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Richard Maziarz, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Myeloproliferative Disorders
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Precancerous Condition
Interventions Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: cyclosporine
Drug: fludarabine phosphate
Drug: mycophenolate mofetil
Procedure: peripheral blood stem cell transplantation
Radiation: Total Body Irradiation (TBI)
Drug: Granulocyte colony-stimulating factor (G-CSF)
Drug: Phenytoin
Drug: Methotrexate
Enrollment 147
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Period Title: Overall Study
Started 147
Completed 130 [1]
Not Completed 17
Reason Not Completed
Death             17
[1]
17 participants died from infectious complications.
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Baseline Participants 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
<=18 years
0
   0.0%
Between 18 and 65 years
81
  55.1%
>=65 years
66
  44.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Female
49
  33.3%
Male
98
  66.7%
Karnofsky Performance Score (KPS)   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants
KPS ≥ 90
91
  65.5%
KPS < 90
48
  34.5%
[1]
Measure Description:

KPS Scale:

100 = Normal, no complaints, no evidence of disease. 90 = Able to carry on normal activity; minor signs or symptoms of disease. 80 = Normal activity with effort; some signs or symptoms of disease. 70 = Cares for self, unable to carry on normal activity or to do active work. 60 = Requires occasional assistance, but is able to care for most of his/her needs.

50 = Requires considerable assistance and frequent medical care. 40-0 = Not eligible

[2]
Measure Analysis Population Description: Eight patients did not have KPS status available, which is why the values do not add up to the total number of participants.
Pre-Transplant Disease Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
In Complete Remission
85
  57.8%
Not in Complete Remission
62
  42.2%
Disease Risk Index (DRI)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 144 participants
Low or intermediate
93
  64.6%
High or Very High
51
  35.4%
[1]
Measure Analysis Population Description: DRI was unclassifiable in 3 patients.
HLA Match   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
8/8
135
  91.8%
7/8
12
   8.2%
[1]
Measure Description:

HLA Criteria:

Related to the patient and genotypically or phenotypically HLA-identical (8/8). Single antigen mismatch (7/8) can be accepted if no other donor is available.

OR

Unrelated to the patient and HLA matched by molecular typing, allowing a single allele or antigen mismatch (7/8).

Donor Relation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
Related Sibling Donor
39
  26.5%
Unrelated Donor
108
  73.5%
Cytomegalovirus (CMV) Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
-/- recipient/donor
22
  15.7%
All other combinations
118
  84.3%
[1]
Measure Analysis Population Description: Cytomegalovirus (CMV) status was unavailable in 7 patients.
Donor/Recipient Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants
F/F, M/M, M/F
117
  79.6%
F/M
30
  20.4%
1.Primary Outcome
Title Regimen-Related Toxicities
Hide Description Non-hematologic toxicities and adverse experiences ≥ Grade 3 occurrences measured up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant. The following data represents the number of regimen-related, grade 3 and 4 toxicities that occurred in each category.
Time Frame 5 years post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: Toxicities
Cardiac Disorders 21
Renal Disorders 10
Respiratory Disorders 8
CNS Disorders 16
Hepatic Disorders 39
General Disorders 30
2.Primary Outcome
Title Non-relapse Mortality
Hide Description Percent of subjects with non-relapse mortality two years after conditioning with busulfan with fludarabine/200 cGy TBI in patients with hematologic malignancies at moderate to high risk for graft rejection and/or relapse of underlying disease.
Time Frame Two years post-transplant
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Count of Participants
Unit of Measure: Participants
Year 1
27
  18.4%
Year 2
33
  22.4%
3.Secondary Outcome
Title Overall Survival
Hide Description The percentage of overall patient survival (out of 147 participants) for Years 1, 2, 3 and 5.
Time Frame Years 1, 2, 3 and 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of analyzed participants
Year 1 60
Year 2 48
Year 3 42
Year 5 29
4.Secondary Outcome
Title Progression-Free Survival
Hide Description

The percentage of progression-free patients (out of 147 participants) at Years 1, 2, 3, and 5.

Definition of Disease Progression:

MM/Plasma Cell: Increasing bone pain or increase in serum/urine monoclonal protein by 25%.

CLL/NHL/HD: New sites of lymphadenopathy; ≥ 25% increase in lymph node size; Blood or bone marrow involvement with clonal B-cells; Increase of ≥ 25% bone marrow involvement; ≥ 25% increase in blood involvement with clonal B-cells.

AML/ALL: Any incidence of relapse (>5% blasts) by evaluation of the bone marrow aspirate.

CML: Inability to control platelet or granulocyte counts; Increase in baseline number of metaphases demonstrating the Ph+ chromosome by >25%; Any other new cytogenetic abnormality; Transformation to accelerated phase or blast crisis.

MDS/MPD: Any evidence by morphologic or flow cytometric evaluation of the bone marrow aspirate of new blasts (>5%) or worsening cytopenia or cytogenetic evidence of recurrence.

Time Frame Years 1, 2, 3, and 5
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of analyzed participants
Year 1 48
Year 2 39
Year 3 35
Year 5 29
5.Secondary Outcome
Title Relapse Mortality
Hide Description The percentage of patients (out of 147 participants) who relapsed at Years 1 and 2. Relapse is defined as the presence of >5% blasts by morphology on a post-transplant bone marrow aspirate.
Time Frame Years 1 and 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of analyzed participants
Year 1 13
Year 2 20
6.Secondary Outcome
Title Acute Graft-Versus-Host Disease (aGVHD) Outcome
Hide Description

Grading of Acute GVHD:

Severity of Individual Organ Involvement:

Skin

  • 1 a maculopapular eruption involving less than 25% of the body surface
  • 2 a maculopapular eruption involving 25-50% of the body surface
  • 3 generalized erythroderma
  • 4 generalized erythroderma with bullous formation and/or with desquamation Liver
  • 1 bilirubin 2.0-3.0mg/100mL
  • 2 bilirubin 3-5.9mg/100mL
  • 3 bilirubin 6-14.9mg/100mL
  • 4 bilirubin >15mg/100mL Gut Diarrhea is graded +1 to +4 in severity. Nausea/vomiting and/or anorexia caused by GVHD is assigned as +1 in severity Diarrhea
  • 1 <1000mL of liquid stool/day
  • 2 >1,000mL of stool/day
  • 3 >1,500mL of stool/day
  • 4 2,000mL of stool/day, severe abdominal pain, with or without ileus

Severity of GVHD:

Grade 1 +1 to +2 skin rash; No gut or liver involvement Grade 2 +1 to +3 skin rash;+1 GI involvement and/or +1 liver

Time Frame Day 100, Month 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This is cumulative incidence of grades 2-4 aGVHD at 100 days and at 6 months. Out of the total number of participants, grades 2-4 aGVHD occurred in 79 patients.
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of analyzed participants
Day 100 55
Month 6 60
7.Secondary Outcome
Title Chronic Graft-Versus-Host Disease (cGVHD) Outcome
Hide Description

Grading of Chronic GVHD:

Limited: Localized skin involvement and/or hepatic dysfunction due to chronic GVHD

Extensive:

One or more of the following:

Generalized skin involvement Liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis Involvement of the eye: Schirmer’s test with <5 mm wetting Involvement of minor salivary glands or oral mucosa demonstrated on labial biopsy Involvement of any other target organ

Chronic GVHD Severity:

Mild: Signs and symptoms of cGVHD do not interfere substantially with function and do not progress once appropriately treated with local therapy or standard systemic therapy.

Moderate: Signs and symptoms of cGVHD interfere somewhat with function despite appropriate therapy or are progressive through first line systemic therapy.

Severe: Signs and symptoms of cGVHD limit function substantially despite appropriate therapy or are progressive through second line systemic therapy

Time Frame Years 1, 2 and 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This is a cumulative incidence of cGVHD at 1 year, 2 years, and 3 years. A total of 99 patients (out of 147) developed cGVHD, 86 patients (87%) with extensive stage cGVHD and 13 patients (13%) with limited stage cGVHD.
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description:

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of analyzed participants
Year 1 64.6
Year 2 66
Year 3 67.3
Time Frame Non-hematologic toxicities and adverse experiences ≥ Grade 3 will be assessed up to day +100 using the NCI Common Toxicity Criteria for Adverse Events v3.0 (CTCAE). Infections and GVHD will be assessed up to 5 years post transplant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Hide Arm/Group Description

Busulfan 3.2 mg/kg IV on day -5 Fludarabine 30 mg/m2/day x 3 (total dose 90 mg/m2, day -4 to day -2 TBI 200 centigray (cGy) x 1, day 0

Therapeutic allogeneic lymphocytes: A population of lymphocytes therapeutically administered to a recipient individual who is genetically distinct from a donor of the same species.

Busulfan: Busulfan is an alkylating chemotherapeutic agent which has been used in many high dose and reduced intensity regimens prior to allogeneic or autologous hematopoietic stem cell transplants. It is active in a wide variety of malignancies and in high-doses it is myeloablative.

IV Busulfan is available and diluted and administered per package insert guidelines.

Cyclosporine: Cyclosporine is a cyclic polypeptide immunosuppressive agent. It blocks the calcium-dependent calcineurin-mediated nuclear localization of nuclear factor of activated T cells (NFAT) following T-cell activation, thereby inhibiting transactivation of key T-cell response genes including

All-Cause Mortality
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Affected / at Risk (%)
Total   59/147 (40.14%) 
Cardiac disorders   
Left ventricular systolic dysfunction  1 [1]  1/147 (0.68%) 
Pericardial effusion  1 [1]  2/147 (1.36%) 
Atrial fibrillation/flutter  1 [1]  3/147 (2.04%) 
Left ventricular dysfunction  1 [1]  1/147 (0.68%) 
Respiratory pulseless electrical activity (PEA) arrest  1 [1]  1/147 (0.68%) 
General disorders   
Iron overload  1 [1]  1/147 (0.68%) 
Steroid myopathy  1 [1]  3/147 (2.04%) 
Hemolysis  1 [1]  5/147 (3.40%) 
ABO incompatability  1 [1]  1/147 (0.68%) 
Bleeding  1 [1]  2/147 (1.36%) 
Thrombosis/deep vein thrombosis  1 [1]  5/147 (3.40%) 
Thrombotic thrombocytopenic purpura (TTP)  1 [1]  1/147 (0.68%) 
Refractory ascites  1 [1]  1/147 (0.68%) 
Ogilvie’s syndrome  1 [1]  1/147 (0.68%) 
Hepatobiliary disorders   
Veno-occlusive disease  1 [1]  1/147 (0.68%) 
Infections and infestations   
Death Caused by Bacterial Infection * 1 [2]  7/147 (4.76%) 
Death Caused by Fungal Infection * 1 [2]  3/147 (2.04%) 
Death Caused by Sepsis/Septic Shock * 1 [2]  3/147 (2.04%) 
Death Caused by Viral Infection * 1 [2]  3/147 (2.04%) 
Death Caused by Nonspecified Pneumonia * 1 [2]  1/147 (0.68%) 
Musculoskeletal and connective tissue disorders   
Fractures/musculoskeletal  1 [1]  3/147 (2.04%) 
Nervous system disorders   
CsA toxicity  1 [1]  5/147 (3.40%) 
Posterior-reversible encephalopathy syndrome  1 [1]  2/147 (1.36%) 
Renal and urinary disorders   
Event associated with CsA  1 [1]  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders   
Cryptogenic organizing pneumonia  1 [1]  1/147 (0.68%) 
Eosinophilic pneumonia  1 [1]  1/147 (0.68%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Related to regimen
[2]
Unrelated to regimen
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Busulfan (Bu), Fludarabine (Flu), Total Body Iradiation (TBI)
Affected / at Risk (%)
Total   52/147 (35.37%) 
Hepatobiliary disorders   
Hyperbilirubinemia or transaminitis  1 [1]  38/147 (25.85%) 
Infections and infestations   
Neutropenic fever  1 [2]  14/147 (9.52%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Related to regimen
[2]
Unrelated to Regimen
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard T. Maziarz, MD
Organization: Oregon Health and Science University
Phone: 503-494-6345
Responsible Party: Richard Maziarz, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00245037     History of Changes
Other Study ID Numbers: IRB00000210
P30CA016058 ( U.S. NIH Grant/Contract )
OHSU-HEM-05011-L ( Other Identifier: OHSU Knight Cancer Institute )
OHSU-210 ( Other Identifier: OHSU IRB )
First Submitted: October 25, 2005
First Posted: October 27, 2005
Results First Submitted: April 20, 2017
Results First Posted: July 2, 2017
Last Update Posted: September 27, 2017