NCT00741455 · ADVERSE EVENTS

Adverse events

Chemotherapy Followed by Allogeneic Stem Cell Transplantation for Hematologic Malignancies · Source last updated 2020-11-23

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: All-Cause Mortality was assessed for up to 15 years post-transplant. Adverse event data was not collected.
Other-event reporting threshold: 5%

Serious Adverse Event data was not collected. Other \[Not Including Serious\] Adverse Events were not monitored/assessed

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Study Treatment Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k	0 / 0	0 / 0	10 / 17

Group identifiers: EG000: Study Treatment

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

Complete source fields

description

Serious Adverse Event data was not collected. Other \[Not Including Serious\] Adverse Events were not monitored/assessed

event Groups

deaths Num Affected
10
deaths Num At Risk
17
description
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
id
EG000
other Num Affected
0
other Num At Risk
0
serious Num Affected
0
serious Num At Risk
0
title
Study Treatment

frequency Threshold

time Frame

All-Cause Mortality was assessed for up to 15 years post-transplant. Adverse event data was not collected.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice