Trial Outcomes & Findings for Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide (NCT NCT00800839)
NCT ID: NCT00800839
Last Updated: 2016-09-19
Results Overview
Graft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2016-09-19
Participant Flow
Recruitment Period: September 02, 2008 to December 12, 2011. All recruitment was done at The University of Texas (UT) MD Anderson Cancer Center.
Participant milestones
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Overall Study
STARTED
|
56
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
Baseline characteristics by cohort
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantGraft Versus Host Disease (GVHD) defined as grade 2 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Cumulative Incidence of Grade II to IV Acute GVHD
|
53 percentage of incidence
Interval 40.0 to 70.0
|
PRIMARY outcome
Timeframe: 100 days post transplantGraft Versus Host Disease (GVHD) defined as grade 3 to 4 GVHD within first 100 days post transplant. Death or disease progression before diagnosis of GVHD were considered competing risks in the estimation of the incidence of acute GVHD.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Cumulative Incidence of Grade III to IV Acute GVHD
|
22 percentage of incidence
Interval 13.0 to 38.0
|
PRIMARY outcome
Timeframe: 100 days post transplantTreatment-Related Mortality (TRM) was estimated from the date of transplant using the cumulative incidence method to account for competing risks. Disease progression or relapse death were considered competing risk for TRM.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Day-100 Treatment-Related Mortality
|
14 percentage of participants
Interval 7.0 to 28.0
|
SECONDARY outcome
Timeframe: From engraftment to 60 days post transplantEngraftment defined as the evidence of donor derived cells (more than 5%) by bone marrow chimerism studies in the presence of neutrophil recovery by day 28 post stem cell (SC) infusion. Engraftment date is the first day of three (3) consecutive days that the ANC exceeds 0.5 x109/L. Delayed engraftment is defined as the evidence of engraftment beyond day 28 post SC infusion achieved after the administration of therapeutic (high dose) hematopoietic growth factors.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Rate of Engraftment
|
18 days
Interval 18.0 to 38.0
|
SECONDARY outcome
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 yearsProgression-free survival (PFS) is defined as the interval between day of transplant and day of death or disease progression.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
2-year Progression-Free Survival
|
26 percentage of participants
Interval 15.0 to 39.0
|
SECONDARY outcome
Timeframe: First 25-35 days post transplant and then every 3 months for a maximum of 2 yearsOverall Survival (OS) is defined as the interval between day of transplant and day of death.
Outcome measures
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=49 Participants
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
2-year Overall Survival
|
33 percentage of participants
Interval 20.0 to 46.0
|
Adverse Events
Busulfan + Fludarabine + Cyclophosphamide
Serious events: 39 serious events
Other events: 54 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=56 participants at risk
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
General disorders
Death
|
69.6%
39/56 • Number of events 39 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
BK virus associated hemorrhagic cystitis
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Cardio-renal syndrome
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Chronic GI GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Eye disorders
Chronic ocular GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Delayed engraftment due to Cytoxan
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated bilirubin due to Sepsis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Delayed Engraftment
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated alanine aminotransferase due to drug related
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated bilirubin due to drug related
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
GI GvHD
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Graft Failure due to Relapsed MDS
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Graft Failure due to micro-environment
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Graft Failure due to Rejection
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Vascular disorders
Hemorrhage due to low PLT
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Viral
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Hepatobiliary disorders
Liver GvHD
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Bacterial
|
7.1%
4/56 • Number of events 5 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Fungal
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Neutropenic typhlitis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Presumed viral encephalitis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Primary Graft Failure
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Presumed fungal pneumonia
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia due to Valcyte
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin GVHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
Other adverse events
| Measure |
Busulfan + Fludarabine + Cyclophosphamide
n=56 participants at risk
Busulfan starting dose of 32 mg/m\^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m\^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain due to Doxycycline
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Allergic reaction due to Platelet transfusion
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Allergic reaction due to Cell infusion
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Altered mental status changes due to drug related
|
10.7%
6/56 • Number of events 6 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Altered mental status changes due to ATG
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Altered mental status changes
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Atrial fibrilation due to dexamethasone
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Atrial fibrilation
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
BK virus associated hemorrhagic cystitis
|
42.9%
24/56 • Number of events 24 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain due to Neupogen
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Eye disorders
Chronic ocular GvHD
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Chronic skin GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Chronic upper GI GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Vascular disorders
Deep vein thrombosis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Congestive heart failure
|
8.9%
5/56 • Number of events 5 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Demodex folliculitis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Dermatitis drug eruption vs GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
21/56 • Number of events 22 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Dizziness due to Dilantin
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Dysphagia due to radiation treatment
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated alanine aminotransferase
|
10.7%
6/56 • Number of events 6 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated alanine aminotransferase due to drug related
|
12.5%
7/56 • Number of events 7 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated alkaline phosphatase
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated alkaline phosphatase due to drug related
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated bilirubin
|
16.1%
9/56 • Number of events 9 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated bilirubin due to RBC transfusions
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated bilirubin due to drug related
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Elevated lactate dehydrogenase due to Vancomycin
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Engraftment syndrome
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
General disorders
Fevers
|
17.9%
10/56 • Number of events 10 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
General disorders
Fevers due to ATG
|
33.9%
19/56 • Number of events 19 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
General disorders
Fevers due to Engraftment Syndrome
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
General disorders
Fevers due to Transfusion
|
1.8%
1/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Fluid overload
|
30.4%
17/56 • Number of events 17 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Folliculitis
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
GI GvHD
|
16.1%
9/56 • Number of events 9 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
GI bleed of undetermnined cause
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Headaches
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Hemochromatosis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Vascular disorders
Hemorrhage of undetermined etiology
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Hypertension
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Hypertension due to Tacrolimus
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Hypotension due to Norvasc
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Hypotension
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Bacterial
|
64.3%
36/56 • Number of events 65 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Fungal
|
8.9%
5/56 • Number of events 6 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Infections Viral
|
58.9%
33/56 • Number of events 51 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Vascular disorders
Line related deep vein thrombosis
|
7.1%
4/56 • Number of events 4 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Hepatobiliary disorders
Liver GvHD
|
10.7%
6/56 • Number of events 9 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Left ventricular dysfunction
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Myopathy due to Tramadol
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Magnesium induced diarrhea
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Mucositis
|
85.7%
48/56 • Number of events 48 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
48/56 • Number of events 49 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Nausea due to drug related
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Nausea due to CMV infection
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Neuropathy
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Infections and infestations
Neutropenic fevers
|
53.6%
30/56 • Number of events 30 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Oral GvHD
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Eye disorders
Ocular GvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
12.5%
7/56 • Number of events 7 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Eye disorders
Propionibaterium acnes conjunctivitis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus due to Bactrim
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.9%
5/56 • Number of events 5 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash due to ATG
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Rash due to drug related
|
8.9%
5/56 • Number of events 6 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Red cell dysplasia due to ABO incompatibility
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Nephrotoxins
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Pyelonephritis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Overt diuresis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to drug related
|
16.1%
9/56 • Number of events 9 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Obstructive neuropathy
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Obstructive uropathy
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Renal and urinary disorders
Renal insufficiency due to Hemorrhagic cystitis
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath due to platelet transfusion
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Reproductive system and breast disorders
Severe vulvar discomfort
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Skin and subcutaneous tissue disorders
Skin GVHD
|
44.6%
25/56 • Number of events 27 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Musculoskeletal and connective tissue disorders
Steroid-Induced Myopathy
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Small bowel obstruction from pneumatosis coli
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Steroid induced hyperglycemia
|
28.6%
16/56 • Number of events 16 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Suspected cGvHD
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Metabolism and nutrition disorders
Suspected metabolic encephalopathy
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Nervous system disorders
Suspected migraine
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Suspected Ganciclovir induced diarrhea
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Immune system disorders
Suspected engraftment syndrome
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
General disorders
Ulcer
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Gastrointestinal disorders
Upper GI GvHD
|
16.1%
9/56 • Number of events 9 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia due to drug related
|
3.6%
2/56 • Number of events 2 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
|
Cardiac disorders
Tachycardia
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from time of informed consent, first 25-35 days post transplant and then every 3 months up to 2 years.
|
Additional Information
Amin M. Alousi, MD/Stem Cell Transplantation
The University of Texas (UT) MD Anderson Cancer Center
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place