Trial Outcomes & Findings for Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders (NCT NCT00553098)
NCT ID: NCT00553098
Last Updated: 2020-02-17
Results Overview
The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
29 participants
Primary outcome timeframe
At 1 year post transplant
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Alemtuzumab, Fludarabine Phosphate, and Total-Body Irradiation Followed by a Donor Stem Cell Transplant in Treating Patients With Immunodeficiency or Other Nonmalignant Inherited Disorders
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=28 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 1 year post transplantPopulation: Excludes 9 patients who expired prior to 1 year
The study will be considered a success and the protocol worthy of further study if there is sufficient evidence that this rate is greater than the 50% rate observed in the most recently transplanted patients with nonmalignant disorders. Analyses will be carried out separately for the alemtuzumab recipients and the TBI recipients. We will be 80% confidence of success if a one-sided 80% confidence interval for the proportion of patients with successful chimerism exceeds 50%. Cumulative incidence will be used to evaluate the probability of chimerism.
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=19 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Number of Patients Who Achieve Greater Than 50% Donor T-cell Chimerism
|
13 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 3 patients with graft rejection and second transplant prior to 1 year.
Number of patients alive at 1 year
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=25 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Overall Survival
|
19 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 16 patients: 13 patients who did not achieve 1 year time point (9 expired, 4 went to second transplant) and 3 patients for whom no data was sent at 1 year from external site
Number of patients with normal range CD3 at 1 year post transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=12 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Immune Reconstitution by 1 Year Post Transplant
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 9 patients who expired prior to 1 year time point.
Number of patients at 1 year with disease response (defined as no clinical evidence of active disease and/or sufficient level of donor chimerisms to prevent disease recurrence)
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=19 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Disease Response by 1 Year Post Transplant
|
15 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 9 patients who expired prior to 1 year time point
Number of patients who achieve greater than 50% CD33+ donor chimerisms at 1 year post transplant.
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=19 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Greater Than 50% CD33+ Donor Chimerisms at 1 Year Post Transplant
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 9 patients who expired prior to 1 year time point
Number of Patients Who Achieve Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=19 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Greater Than 50% CD19+ Donor Chimerisms at 1 Year Post Transplant
|
16 Participants
|
SECONDARY outcome
Timeframe: 100 daysNumber of patients who experienced a clinical significant infection, requiring treatment, within 100 days post transplant.
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=28 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Clinical Significant Infection, Requiring Treatment, Within 100 Days Post Transplant
|
21 Participants
|
SECONDARY outcome
Timeframe: Day 100Number of patients diagnosed with acute GVHD by Day 100 post transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=28 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Number of Patients Diagnosed With Acute GVHD
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 100Population: Excludes 10 patients who were not diagnosed with acute GVHD
Number of patients diagnosed with overall grade I or grade II acute GVHD by Day 100 post transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=18 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Number of Patients Diagnosed With Overall Grade 1 or Grade 2 Acute GVHD
|
12 Participants
|
SECONDARY outcome
Timeframe: Day 100Population: Excludes 10 patients who were not diagnosed with acute GVHD
Number of patients diagnosed with overall Grade III or Grade IV Acute GVHD by Day 100 post transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=18 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Number of Patients Diagnosed With Overall Grade III or Grade IV Acute GVHD
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Excludes 6 patients who expired prior to Day 100
Number of patients diagnosed with chronic GVHD within 1 year post transplant
Outcome measures
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=22 Participants
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Number of Patients Diagnosed With Chronic GVHD
|
8 Participants
|
Adverse Events
Treatment (Chemotherapy, Low Dose Radiation)
Serious events: 10 serious events
Other events: 13 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=28 participants at risk
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV
Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Cardiac disorders
Pericardial Effusion
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Infections and infestations
Sepsis
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Cardiac disorders
Cardiorspiratory Failure
|
10.7%
3/28 • Number of events 3 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
7.1%
2/28 • Number of events 2 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
7.1%
2/28 • Number of events 2 • Day 200 post initiation of conditioning therapy
|
Other adverse events
| Measure |
Treatment (Chemotherapy, Low Dose Radiation)
n=28 participants at risk
CONDITIONING REGIMEN: \*Patients with no life-threatening viral or fungal infections within 1 month before the planned HCT receive alemtuzumab IV over 6 hours on day -10 and fludarabine phosphate IV over 30 minutes on days -4 to -2. They also undergo low-dose TBI on day 0. Patients with HLH, IPEX syndrome, DiGeorge syndrome, or life-threatening viral or fungal infections within 1 month before the planned HCT receive fludarabine phosphate IV over 30 minutes on days -4 to -2 and undergo 2 low doses of TBI on day 0.
HEMATOPOIETIC CELL TRANSPLANTATION: Patients undergo HCT on day 0.
IMMUNOSUPPRESSION: Patients receive cyclosporine IV or PO 2-3 times daily beginning on day -3 and continuing until day 100 followed by a taper until day 180. They also receive mycophenolate mofetil IV or PO 3 times daily beginning on day 0 and continuing until day 40 followed by a taper until day 96.
Alemtuzumab: Given IV
Allogeneic Bone Marrow Transplantation: Undergo HCT Allogeneic Hematopoiet
|
|---|---|
|
Blood and lymphatic system disorders
Bleeding - GI
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
21.4%
6/28 • Number of events 7 • Day 200 post initiation of conditioning therapy
|
|
Cardiac disorders
Hypertension
|
7.1%
2/28 • Number of events 2 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Infections and infestations
Fever of Unknown Origin
|
10.7%
3/28 • Number of events 3 • Day 200 post initiation of conditioning therapy
|
|
Cardiac disorders
Tachycardia
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Renal and urinary disorders
Renal Insufficiency
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Renal and urinary disorders
Renal Failure, requiring dialysis
|
7.1%
2/28 • Number of events 2 • Day 200 post initiation of conditioning therapy
|
|
Gastrointestinal disorders
Pancreatitis
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Gastrointestinal disorders
Mucositis
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Blood and lymphatic system disorders
Hemolysis
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Cardiac disorders
Cardiovascular, not otherwise specified
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Blood and lymphatic system disorders
Bleeding - Vaginal
|
3.6%
1/28 • Number of events 2 • Day 200 post initiation of conditioning therapy
|
|
Blood and lymphatic system disorders
Bleeding - Lung
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Blood and lymphatic system disorders
Bleeding - CNS
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
|
Renal and urinary disorders
Acute Kidney Injury
|
3.6%
1/28 • Number of events 1 • Day 200 post initiation of conditioning therapy
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place