Trial Outcomes & Findings for Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies. (NCT NCT05579769)
NCT ID: NCT05579769
Last Updated: 2025-10-02
Results Overview
Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
100 days post transplant
Results posted on
2025-10-02
Participant Flow
Participant milestones
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pediatric Study of GVHD Ppx w/o Calcineurin Inhibitors After Day60 Post First Allo HSCT for Hematological Malignancies.
Baseline characteristics by cohort
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.5 years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
17 years
STANDARD_DEVIATION 0 • n=7 Participants
|
16.25 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantPopulation: None of the 3 participants had saGVHD.
Development of Severe Acute GVHD (saGVHD) at or before Day 100 post transplant is considered as an event. Severe acute GVHD is defined as grade II-IVGVHD. Acute graft-vs-host disease will be evaluated using the standard grading criteria.
Outcome measures
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBI/Cy regimen: Participants receive TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Proportion of saGVHD Using a ProphylaxisRegimen With no Calcineurin Inhibitors After Day 100 Post First Allogeneic HLA-Matched Sibling or Unrelated Donor HCT for Hematological Malignancies.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One-year post-transplantation.The one-year survival is defined by the participant who has not died within one year after post transplantation. The rate is calculated by computing the ratio between total number of one year survival patients and the total number of patients.
Outcome measures
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBI/Cy regimen: Participants receive TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Cumulative Incidence of Overall Survival (OS)
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: One-year post-transplantation.Bone marrow studies for disease status evaluation will be performed at 1-year post-transplant. Testing will include a research evaluation for minimal residual disease.
Outcome measures
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBI/Cy regimen: Participants receive TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Cumulative Incidence of Relapse
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One-year post-transplantation.Non-relapse mortality is death without evidence of disease relapse or progression. The rate is calculated by computing the ratio between total number of NRM patients and the total number of patients.
Outcome measures
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBI/Cy regimen: Participants receive TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Cumulative Incidence of Non Relapse Mortality (NRM)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One-year post-transplantation.Chronic graft-vs-host disease will be evaluated using the standard grading criteria.
Outcome measures
| Measure |
Total Body Irradiation (TBI)/Cyclophosphamide (Cy)
n=2 Participants
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBI/Cy regimen: Participants receive TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
Thiotepa, Busulfan, and Fludarabine (TBF)
n=1 Participants
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
TBF regimen: Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive Rabbit ATG.
G-CSF: Use of GCSF is not recommended unless patients have not engrafted on day +21.
Mesna: MESNA will be given for bladder protection to patients who receive Cyclophosphamide.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Cumulative Incidence of Chronic GVHD
|
0 Participants
|
0 Participants
|
Adverse Events
TBI/Cy Regimen
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
TBF Regimen
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TBI/Cy Regimen
n=2 participants at risk
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
TBF Regimen
n=1 participants at risk
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
General disorders
Fever
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
General disorders
Multi-organ failure
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Infections and infestations - Other, specify (Disseminated Adenovirus)
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Lung infection
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Tracheitis
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Investigations
Weight loss
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
Other adverse events
| Measure |
TBI/Cy Regimen
n=2 participants at risk
Patients with lymphoid malignancies will receive Total Body Irradiation (TBI)/Cyclophosphamide (Cy).
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive 8 doses TBI. Cyclophosphamide, IV. Rabbit ATG, IV. Males with lymphoid lineage leukemia will receive an additional testicular boost concurrent with TBI.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Mesna: Mesna will be given IV approximately 15 minutes prior to each dose of cyclophosphamide and approximately 3, 6, 9, and 12 hours after each dose of cyclophosphamide.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
TBF Regimen
n=1 participants at risk
Patients with myeloid, bi-phenotypic, bilineage or undifferentiated leukemia will receive thiotepa, busulfan, and fludarabine (TBF). Patients will receive TBF regimen when TBI is not appropriate.
Bone marrow grafts will be used. HLA-identical sibling donors will be considered first followed by histocompatible relatives or unrelated donors. Permissive DPB1 mismatched grafts will be included. Unrelated grafts will be obtained through NMDP or other registries.
Participants receive Thiotepa, IV. Busulfan, IV. Fludarabine, IV. Rabbit ATG, IV.
Patients who receive a bone marrow product from MSD will not receive rATG.
G-CSF: Use of GCSF is not recommended except after day +21 when a single dose not exceeding 2.5mcg/kg may be given after rounding off if APC is \>500 cells/mm3, and ANC is\<500 cells/mm3 to mobilize cells.
Levetiracetam IV will be prescribed as seizure prophylaxis for recipients receiving busulfan.
GVHD prophylaxis: Cyclosporine, IV. Methotrexate, IV. Ruxolitinib, Oral or NG.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify (Thrombotic Microangiopathy)
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Gastrointestinal disorders
Ileus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • Number of events 2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Hepatobiliary disorders
Sinusoidal obstruction syndrome
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Cytomegalovirus infection reactivation
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Enterocolitis infectious
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Epstein-Barr virus infection reactivation
|
100.0%
2/2 • Number of events 2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Fungemia
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Sepsis
|
100.0%
2/2 • Number of events 2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Staphylococcus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
100.0%
2/2 • Number of events 2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Investigations
Neutrophil count decreased
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Nervous system disorders
Encephalopathy
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Renal and urinary disorders
Acute kidney injury
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-paukar
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Vascular disorders
Hypertension
|
100.0%
2/2 • Number of events 2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
100.0%
1/1 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Vascular disorders
Thromboembolic
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Rhinovirus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Human parainfluenza virus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
|
Infections and infestations
Rhino/Enterovirus
|
50.0%
1/2 • Number of events 1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
0.00%
0/1 • Transplant recipients will be followed for adverse events from the start of conditioning and throughout the first year post-transplant
Recipient participants were followed for all NCI Grade III-V adverse events from the start of conditioning through the first-year post HCT, up to 14 months, regardless of their relationship to the treatment given.
|
Additional Information
Dr. Ashok Srinivasan
St. Jude Children's Research Hospital
Phone: 8662785833
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place