NCT01300572 · OUTCOME

Rates of Acute GvHD

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS · Source last updated 2019-12-10

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

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: Up to 84 days post-transplant

What was measured

Number of participants who developed acute GVHD post-transplant, aGVHD stages: Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

Analysis population: Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.

Groups in this outcome

Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	14

Reported measurements

Source class 1

Grade 0 acute GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	4	Not reported	Not reported	Not reported	Not reported

Grade I acute GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	1	Not reported	Not reported	Not reported	Not reported

Grade II acute GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	6	Not reported	Not reported	Not reported	Not reported

Grade III acute GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	2	Not reported	Not reported	Not reported	Not reported

Grade IV acute GVHD

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
4
title
Grade 0 acute GVHD
measurements
group Id
OG000
value
1
title
Grade I acute GVHD
measurements
group Id
OG000
value
6
title
Grade II acute GVHD
measurements
group Id
OG000
value
2
title
Grade III acute GVHD
measurements
group Id
OG000
value
1
title
Grade IV acute GVHD

denoms

counts
group Id
OG000
value
14
units
Participants

description

groups

description
PREPARATIVE REGIMEN: Patients receive 90Y-BC8 via central line on approximately day -12, fludarabine phosphate IV over 30 minutes on days -4 to -2, and 2 Gy TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive mycophenolate mofetil PO or IV every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on days 0-40 with taper to day 96 (for patients with unrelated donors). Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 (for patients with related donors) or 100 (for patients with unrelated donors) with taper to day 180. Allogeneic Bone Marrow Transplantation: Undergo allogeneic bone marrow transplant Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or bone marrow transplant Cyclosporine: Given PO or IV Fludarabine Phosphate: Given IV Indium In 111 Anti-CD45 Monoclonal Antibody BC8: Given IV (dosimetric dose)
id
OG000
title
Treatment (90Y-BC8, Allogeneic PBSC or Bone Marrow Transplant)

param Type

COUNT_OF_PARTICIPANTS

population Description

Overall number of participants analyzed is 14 because one patient died prior to d+84 after transplant.

reporting Status

POSTED

time Frame

Up to 84 days post-transplant

title

Rates of Acute GvHD

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice