Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
Study Details
Study Description
Brief Summary
This phase II trial is studying how well giving treosulfan together with fludarabine phosphate and total-body irradiation followed by donor stem cell transplant works in treating patients with high-risk acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia. Giving chemotherapy, such as treosulfan and fludarabine phosphate, and total-body irradiation before a donor bone marrow or peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus and methotrexate before and after transplant may stop this from happening
Detailed Description
PRIMARY OBJECTIVES:
- Decrease the incidence of relapse to < 15% at 6 month post transplant in patients with high risk acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) transplanted from related or unrelated donors, without unacceptably increasing toxicity (10% non-relapse mortality [NRM] at 6 months).
SECONDARY OBJECTIVES:
-
Evaluate the incidence of NRM at 180 days and 1 year after hematopoietic cell transplantation (HCT).
-
Evaluate overall survival (OS) and relapse-free survival (RFS). III. Incidence of grades II-IV acute graft-versus-host disease (GVHD). IV. Incidence of chronic GVHD. V. Donor chimerism on days +28 and +100.
OUTLINE:
CONDITIONING REGIMEN: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0.
TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally (PO) twice daily (BID) on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
After completion of study treatment, patients are followed up periodically.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment (allogeneic transplantation) CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. |
Drug: treosulfan
Given IV
Other Names:
Drug: fludarabine phosphate
Given IV
Other Names:
Radiation: total-body irradiation
Low dose starting at 2Gy
Other Names:
Procedure: peripheral blood stem cell transplantation
Given IV per institutional standard practice
Other Names:
Drug: tacrolimus
Given IV or PO
Other Names:
Procedure: allogeneic bone marrow transplantation
Given IV per institutional standard practice
Other Names:
Procedure: allogeneic hematopoietic stem cell transplantation
Given IV per institutional standard practice
Drug: methotrexate
Given IV
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Relapse Incidence [At 6 months]
- Non Relapse Mortality (NRM) Incidence [At 6 months]
Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.
Secondary Outcome Measures
- Non Relapse Mortality Incidence [1 year after HCT]
- Overall Survival (OS) [at 2 years]
- Relapse-free Survival [at 2 years]
- Incidence of Grades II-IV Acute GVHD [at 6 months]
- Incidence of Chronic GVHD [at 6 months]
- Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood [Day 28 after HCT]
Donor chimerism was evaluated in peripheral blood T cells
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Acute myeloid leukemia (AML):
-
All AML patients beyond 1st remission;
-
Intermediate or high risk AML patients (based on South West Oncology Group [SWOG] cytogenetic criteria) in 1st complete remission
-
Myelodysplastic syndrome (MDS)
-
Other myeloid malignancies as chronic myelogenous leukemia (CML), CML accelerated phase, CML blast crisis, chronic myelomonocytic leukemia (CMML) (to be approved by patient care conference [PCC])
-
With Karnofsky Index or Lansky Play-Performance Scale > 70% on pre-transplant evaluation
-
Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
-
Previous autologous or allogeneic HCT is allowed
-
Donors must be:
-
Human leukocyte antigen (HLA)-identical related donors or
-
Unrelated donors matched for HLA-A, B, C, DRB1, and DQB1 defined by high resolution deoxyribonucleic acid (DNA) typing or mismatched for one HLA allele, except for HLA-C where no mismatch is allowed
-
Able to undergo peripheral blood stem cell collection or bone marrow harvest
-
In good general health, with a Karnofsky or Lansky Play Performance score > 90%
-
Able to give informed consent (if > 18 years), or with a legal guardian capable of giving informed consent (if < 18 years)
-
Acute lymphoblastic leukemia (ALL): all ALL patients not eligible for other protocols
Exclusion Criteria:
-
Receiving umbilical cord blood
-
With impaired cardiac function as evidenced by ejection fraction < 35% or cardiac insufficiency requiring treatment or symptomatic coronary artery disease
-
With impaired pulmonary function as evidenced by partial pressure of oxygen (pO2) < 70 mm Hg and diffusing capacity of the lung for carbon monoxide (DLCO) < 70% of predicted or pO2 < 80 mm Hg and DLCO < 60% of predicted; or receiving supplementary continuous oxygen
-
With impaired renal function as evidenced by creatinine-clearance < 50% for age, weight, height or serum creatinine > 2x upper normal limit or dialysis-dependent
-
With hepatic dysfunction as evidenced by total bilirubin or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 x upper normal limit or evidence of synthetic dysfunction or severe cirrhosis
-
With active infectious disease requiring deferral of conditioning, as recommended by an Infectious Disease specialist
-
With human immunodeficiency virus (HIV)-positivity or active infectious hepatitis because of possible risk of lethal infection when treated with immunosuppressive therapy
-
With central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy and/or cranial radiation prior to initiating conditioning (day -6)
-
With life expectancy severely limited by diseases other than malignancy
-
Women who are pregnant or lactating because of possible risk to the fetus or infant
-
With known hypersensitivity to treosulfan and/or fludarabine
-
Receiving another experimental drug within 4 weeks before initiation of conditioning (day -6)
-
Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
-
Ineligible donors will be those:
-
Deemed unable to undergo marrow harvesting or PBSC mobilization and leukapheresis
-
Who are HIV-positive
-
With active infectious hepatitis
-
Females with a positive pregnancy test
-
Unable to give informed consent (if > 18 years) or with a legal guardian (if < 18 years) unable to give informed consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Colorado | Denver | Colorado | United States | 80217-3364 |
2 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
3 | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
- National Heart, Lung, and Blood Institute (NHLBI)
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Boglarka Gyurkocza, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2272.00
- NCI-2010-00315
- P01HL036444
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Period Title: Overall Study | |
STARTED | 96 |
COMPLETED | 93 |
NOT COMPLETED | 3 |
Baseline Characteristics
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Overall Participants | 96 |
Age (years) [Median (Full Range) ] | |
Median (Full Range) [years] |
51
|
Sex: Female, Male (Count of Participants) | |
Female |
39
40.6%
|
Male |
57
59.4%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
3
3.1%
|
Not Hispanic or Latino |
93
96.9%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
2
2.1%
|
Asian |
2
2.1%
|
Native Hawaiian or Other Pacific Islander |
2
2.1%
|
Black or African American |
1
1%
|
White |
87
90.6%
|
More than one race |
2
2.1%
|
Unknown or Not Reported |
0
0%
|
Region of Enrollment (Count of Participants) | |
United States |
96
100%
|
Outcome Measures
Title | Relapse Incidence |
---|---|
Description | |
Time Frame | At 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
18
18.8%
|
Title | Non Relapse Mortality (NRM) Incidence |
---|---|
Description | Cumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression. |
Time Frame | At 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
6
6.3%
|
Title | Non Relapse Mortality Incidence |
---|---|
Description | |
Time Frame | 1 year after HCT |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
6
6.3%
|
Title | Overall Survival (OS) |
---|---|
Description | |
Time Frame | at 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
71
74%
|
Title | Relapse-free Survival |
---|---|
Description | |
Time Frame | at 2 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
62
64.6%
|
Title | Incidence of Grades II-IV Acute GVHD |
---|---|
Description | |
Time Frame | at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
57
59.4%
|
Title | Incidence of Chronic GVHD |
---|---|
Description | |
Time Frame | at 6 months |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 96 |
Count of Participants [Participants] |
20
20.8%
|
Title | Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood |
---|---|
Description | Donor chimerism was evaluated in peripheral blood T cells |
Time Frame | Day 28 after HCT |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Treatment (Allogeneic Transplantation) |
---|---|
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV |
Measure Participants | 87 |
Median (Full Range) [percentage of T cells] |
100
|
Adverse Events
Time Frame | Toxicities Before Day 100 | |
---|---|---|
Adverse Event Reporting Description | Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0 | |
Arm/Group Title | Treatment (Allogeneic Transplantation) | |
Arm/Group Description | CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11. treosulfan: Given IV fludarabine phosphate: Given IV total-body irradiation: Low dose starting at 2Gy peripheral blood stem cell transplantation: Given IV per institutional standard practice tacrolimus: Given IV or PO allogeneic bone marrow transplantation: Given IV per institutional standard practice allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice methotrexate: Given IV | |
All Cause Mortality |
||
Treatment (Allogeneic Transplantation) | ||
Affected / at Risk (%) | # Events | |
Total | 21/96 (21.9%) | |
Serious Adverse Events |
||
Treatment (Allogeneic Transplantation) | ||
Affected / at Risk (%) | # Events | |
Total | 17/96 (17.7%) | |
Cardiac disorders | ||
Heart failure | 1/96 (1%) | |
Hypotension | 1/96 (1%) | |
Gastrointestinal disorders | ||
Mucositis | 4/96 (4.2%) | |
Gut GVHD | 1/96 (1%) | |
Hepatobiliary disorders | ||
Bilirubin | 1/96 (1%) | |
Liver failure | 1/96 (1%) | |
AST 2680 | 1/96 (1%) | |
Infections and infestations | ||
Bacterial/sepsis | 1/96 (1%) | |
Sepsis | 4/96 (4.2%) | |
VRE bacteremia/sepsis | 1/96 (1%) | |
Disseminated toxoplasmosis | 1/96 (1%) | |
Enterococcal bacteremia/VRE | 1/96 (1%) | |
CMV pneumonia | 1/96 (1%) | |
Aspirgillus | 1/96 (1%) | |
Metabolism and nutrition disorders | ||
Hyperglycemia | 2/96 (2.1%) | |
Hypoglycemia w/seizures | 1/96 (1%) | |
Hyponatremia | 1/96 (1%) | |
Psychiatric disorders | ||
Apnea | 1/96 (1%) | |
Renal and urinary disorders | ||
Kidney rejection - pre-existing hx kidney transplant | 1/96 (1%) | |
Renal failure/dialysis | 1/96 (1%) | |
Renal failure | 1/96 (1%) | |
Respiratory, thoracic and mediastinal disorders | ||
Acute respiratory distress syndrome (ARDS) | 1/96 (1%) | |
Hypoxia/resp failure | 2/96 (2.1%) | |
Pneumonitis | 1/96 (1%) | |
Intubated secondary to DAH | 1/96 (1%) | |
Respiratory failure/intubated | 1/96 (1%) | |
Cardiac arrythmia | 1/96 (1%) | |
Pul.Edema | 1/96 (1%) | |
Pneumonia | 1/96 (1%) | |
Diffuse alveolar hemorrhage | 1/96 (1%) | |
Other (Not Including Serious) Adverse Events |
||
Treatment (Allogeneic Transplantation) | ||
Affected / at Risk (%) | # Events | |
Total | 68/96 (70.8%) | |
Blood and lymphatic system disorders | ||
Deep vein thrombosis | 1/96 (1%) | |
Thrombotic thrombocytopenic purpura (TTP) coagulation | 1/96 (1%) | |
Cardiac disorders | ||
Atrial Fibrillation | 3/96 (3.1%) | |
Edema | 1/96 (1%) | |
Hypotension | 4/96 (4.2%) | |
LVEF 35% | 1/96 (1%) | |
Sinus tachycardia | 1/96 (1%) | |
Eye disorders | ||
Retinal central vein occlusion | 1/96 (1%) | |
Gastrointestinal disorders | ||
Mucositis | 23/96 (24%) | |
Mucosi | 2/96 (2.1%) | |
Nausea | 5/96 (5.2%) | |
Vomiting | 4/96 (4.2%) | |
Diarrhea | 11/96 (11.5%) | |
Diverticulitis | 1/96 (1%) | |
Anorexia | 1/96 (1%) | |
Other | 1/96 (1%) | |
Abdominal pain | 1/96 (1%) | |
GI bleed | 1/96 (1%) | |
General disorders | ||
Fatigue | 6/96 (6.3%) | |
Adrenal insufficiency | 1/96 (1%) | |
Dehydration | 2/96 (2.1%) | |
Proximal myopathy | 1/96 (1%) | |
Steroid induced DM | 1/96 (1%) | |
LE weakness/deconditioning | 1/96 (1%) | |
Fall | 1/96 (1%) | |
Malnutrition | 1/96 (1%) | |
Hepatobiliary disorders | ||
ALT/AST | 1/96 (1%) | |
ALT | 1/96 (1%) | |
AST | 2/96 (2.1%) | |
t.bili 4.2 | 1/96 (1%) | |
Bilirubin | 1/96 (1%) | |
Infections and infestations | ||
Infections | 56/96 (58.3%) | |
Metabolism and nutrition disorders | ||
Hyperglycemia | 6/96 (6.3%) | |
Elevated ferritin | 1/96 (1%) | |
Hyperkalemia | 1/96 (1%) | |
Musculoskeletal and connective tissue disorders | ||
Pain | 6/96 (6.3%) | |
Myalgia | 2/96 (2.1%) | |
Steroid myopathy | 2/96 (2.1%) | |
Nervous system disorders | ||
Neuropathic leg pain | 1/96 (1%) | |
Syncope | 2/96 (2.1%) | |
Peripheral neuropathy | 1/96 (1%) | |
Posterior reversible encephalopathy syndrome (PRES) | 1/96 (1%) | |
Psychiatric disorders | ||
Confusion | 4/96 (4.2%) | |
Altered Mental Status | 2/96 (2.1%) | |
Hallucinations | 1/96 (1%) | |
Renal and urinary disorders | ||
Dysuria | 1/96 (1%) | |
Acute renal failure/creatinine | 2/96 (2.1%) | |
Creatinine | 1/96 (1%) | |
Renal failure/acidosis | 1/96 (1%) | |
Respiratory, thoracic and mediastinal disorders | ||
Hypoxia | 8/96 (8.3%) | |
Pleural effusion | 2/96 (2.1%) | |
Dyspnea | 1/96 (1%) | |
Pulmonary Embolism | 1/96 (1%) | |
Skin and subcutaneous tissue disorders | ||
Rash | 11/96 (11.5%) |
Limitations/Caveats
More Information
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 | Joachim Deeg |
---|---|
Organization | Fred Hutch/University of Washington Cancer Consortium |
Phone | 206.667.5985 |
jdeeg@fredhutch.org |
- 2272.00
- NCI-2010-00315
- P01HL036444