Trial Outcomes & Findings for Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma (NCT NCT03096782)
NCT ID: NCT03096782
Last Updated: 2023-10-11
Results Overview
Number of days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Up to 12 months after transplant
Results posted on
2023-10-11
Participant Flow
Participants recruitment from October 2017 to May 2022 at MD Anderson Cancer Center
Participant milestones
| Measure |
Chemotherapy Plus Cord Blood Transplant
GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Chemotherapy Plus Cord Blood Transplant
GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Participant Relapsed
|
1
|
Baseline Characteristics
Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
Baseline characteristics by cohort
| Measure |
Chemotherapy and Cord Blood Transfusion
n=6 Participants
All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10.
Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered.
GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Cyclophosphamide: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Melphalan: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 months after transplantNumber of days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days.
Outcome measures
| Measure |
Chemotherapy Plus Cord Blood Transplant
n=6 Participants
GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Time to Engraftment
Twenty Two Days
|
2 Participants
|
|
Time to Engraftment
Twenty Nine Days
|
1 Participants
|
|
Time to Engraftment
Thirty Days
|
1 Participants
|
|
Time to Engraftment
Nine Days
|
1 Participants
|
|
Time to Engraftment
Thirty Two Days
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to12 monthsNumber of participants that were in remission post transplant.
Outcome measures
| Measure |
Chemotherapy Plus Cord Blood Transplant
n=6 Participants
GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Disease-free Survival
Complete Remission at 30 days
|
6 Participants
|
|
Disease-free Survival
Complete Remission at 12 months
|
4 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months after transplantPopulation: One participant died 5 months post transplant.
Number of participants alive 1 year post transplant.
Outcome measures
| Measure |
Chemotherapy Plus Cord Blood Transplant
n=5 Participants
GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Overall Survival
|
4 Participants
|
Adverse Events
Chemotherapy and Cord Blood Transfusion
Serious events: 1 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Chemotherapy and Cord Blood Transfusion
n=6 participants at risk
All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10.
Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered.
GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Cyclophosphamide: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Melphalan: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
Other adverse events
| Measure |
Chemotherapy and Cord Blood Transfusion
n=6 participants at risk
All patients received Busulfan as per standard of care. Busulfan test dose can be administered either as an outpatient prior to admission or as an inpatient on Day -10.
Busulfan pharmacokinetics will be performed with the test dose and the first dose on Day -7 per standard of care. The doses of Days -6, -5, and -4 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting were not possible a dose of busulfan of 130 mg/m2 will be administered.
GVHD PROPHYLAXIS: All patients also receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover.
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Cyclophosphamide: Given IV
Filgrastim-sndz: Given SC
Fludarabine: Given IV
Melphalan: Given IV
Mycophenolate Mofetil: Given IV or PO
Rituximab: Given IV
Tacrolimus: Given IV
Total-Body Irradiation: Undergo total body irradiation
Umbilical Cord Blood Transplantation: Undergo cord blood transplant
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Investigations
Abnormal coagulopathy
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Vascular disorders
Arm pain
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
BK cystitis
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
BK virus
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Eye disorders
Blurry vision
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Cardiac disorders
Chest tightness
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Chills
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Infections and infestations
CMV infection
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Crackles to right lung
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Deconditioning
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Decreased Appetite
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
4/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Eye disorders
Dry Eyes
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Vascular disorders
DVT (thrombosis)
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Renal and urinary disorders
Dysuria
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
E. Coli pneumonia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Fatigue
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Fever
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Fluid Imbalance
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Fluid Overload
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Flu-like Symptoms
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Skin and subcutaneous tissue disorders
Folliculitis
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Constipation
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Generalized body aches
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Hand-foot syndrome
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Nervous system disorders
Headache
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Hematochezia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Hemorrhoids
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Infections and infestations
HHV6 infection
|
66.7%
4/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Investigations
Hyperbilirubinemia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Vascular disorders
Hypertension
|
66.7%
4/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Vascular disorders
Hypotension
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Indigestion (dyspepsia)
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Ingrown toenail
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Renal and urinary disorders
Int elevated ALT
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Eye disorders
Blurred Vision
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Metabolism and nutrition disorders
Malnutrition
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Migraine
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Mucositis
|
100.0%
6/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
6/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Nervous system disorders
Neuropathy
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Neutropenic fever
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Norovirus
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Parainfluenza URI
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Peripheral edema
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Platelet Infusion Reaction
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
6/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Cardiac disorders
Tachycardia
|
33.3%
2/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Infections and infestations
Urinary Tract Infection (BK virus)
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Infections and infestations
Vaginal irritation
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
3/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
General disorders
Transaminitis
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Parainfluenza URI
|
16.7%
1/6 • All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
|
Additional Information
Amanda Olson, MD / Stem Cell Transplantation
University of Texas MD Anderson Cancer Center
Phone: 713-745-1505
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place