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← KEYTRUDA: refractory Hodgkin Lymphoma

NCT00040846 · STUDY IN CONTEXT

Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies

Draft scope assessment: unclear. Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Percentage patients with Day 100 transplant related mortality.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

primary · POSTED

Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. 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 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

primary · POSTED

Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

secondary · POSTED

Percentage patients who experienced infections within 100 days post-transplant.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

secondary · POSTED

Percentage patients who relapsed/progressed within 1 year post-transplant.

No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id: NCT00040846
trial label: Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies
applicability: unclear
applicability note: Attached because the study's own record describes refractory disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 5
harms Count: 6
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
source section id
NCT00040846-om-0000
source outcome index
0
endpoint
Evaluate the Risk of Transplant Related Mortality.
endpoint definition
Percentage patients with Day 100 transplant related mortality.
time origin
100 days after transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
source section id
NCT00040846-om-0001
source outcome index
1
endpoint
Evaluate the Risk of Occurrence of Acute and Chronic GVHD
endpoint definition
Percentage patients who developed acute/chronic GVHD. aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma with bullous formation and often with desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. 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 gastrointestinal involvement and/or +2 to +4 liver involvement, with or without a rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death
time origin
1 year after transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0002
source section id
NCT00040846-om-0002
source outcome index
2
endpoint
Determine Whether Engraftment Can be Maintained With a Single Dose Fludarabine, DLI and Continued MMF/CSP, Defined as Rejection Rate < 20%.
endpoint definition
Mixed chimerism will be defined as the detection of donor T cells (CD3+) and granulocytes (CD 33+), as a proportion of the total T cell and granulocyte population, respectively, of greater than 5% and less than 95% in the peripheral blood. Full donor chimerism is defined as \> 95% donor CD3+ T cells.
time origin
100 days after transplant
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0003
source section id
NCT00040846-om-0003
source outcome index
3
endpoint
Evaluate the Risk/Incidence of Infections
endpoint definition
Percentage patients who experienced infections within 100 days post-transplant.
time origin
100 days after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0004
source section id
NCT00040846-om-0004
source outcome index
4
endpoint
Evaluate the Risk for Disease Progression and Relapse
endpoint definition
Percentage patients who relapsed/progressed within 1 year post-transplant.
time origin
1 year after transplant
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG000
arm label
Dose Level 1 (No Campath)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG001
arm label
Dose Level 2 (0.025 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG002
arm label
Dose Level 3 (0.050 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG003
arm label
Dose Level 4 (0.10 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG004
arm label
Dose Level 5 (0.20 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0000
arm key
OG005
arm label
Dose Level 6 (0.40 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0000#groups/OG005
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG000
arm label
Dose Level 1 (No Campath)
regimen
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO
analyzed count
60
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG001
arm label
Dose Level 2 (0.025 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG002
arm label
Dose Level 3 (0.050 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG003
arm label
Dose Level 4 (0.10 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG004
arm label
Dose Level 5 (0.20 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG004
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
outcome key
om-0001
arm key
OG005
arm label
Dose Level 6 (0.40 mg/kg/Day Campath)
regimen
CONDITIONING REGIMEN: Patients receive Alemtuzumab (Campath) on days -8 to -5 as well as fludarabine phosphate IV on days -4 to -2. Patients also undergo low-dose TBI on day 0. HSCT: Patients undergo allogeneic peripheral blood stem cell transplantation on day 0. IMMUNOSUPPRESSION: Patients receive CSP IV or PO BID on days -3 to 180 with taper to day 365 and MMF PO TID on days 0-100, with taper to day 156. fludarabine phosphate: Given IV total-body irradiation: Undergo TBI allogeneic hematopoietic stem cell transplantation: Undergo allogeneic HSCT peripheral blood stem cell transplantation: Undergo allogeneic peripheral blood stem cell transplantation mycophenolate mofetil: Given PO cyclosporine: Given IV or PO alemtuzumab: Given IV
analyzed count
0
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00040846-om-0001#groups/OG005

harms

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG000
source section id
NCT00040846-ae
event group key
EG000
event group label
Dose Level 1 (No Campath)
serious affected
24
serious at risk
60
other affected
33
other at risk
60
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG001
source section id
NCT00040846-ae
event group key
EG001
event group label
Dose Level 2 (0.025 mg/kg/Day Campath)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG002
source section id
NCT00040846-ae
event group key
EG002
event group label
Dose Level 3 (0.050 mg/kg/Day Campath)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG003
source section id
NCT00040846-ae
event group key
EG003
event group label
Dose Level 4 (0.10 mg/kg/Day Campath)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG004
source section id
NCT00040846-ae
event group key
EG004
event group label
Dose Level 5 (0.20 mg/kg/Day Campath)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-keytruda-7b74c3c0
nct id
NCT00040846
harm key
EG005
source section id
NCT00040846-ae
event group key
EG005
event group label
Dose Level 6 (0.40 mg/kg/Day Campath)
serious affected
0
serious at risk
0
other affected
0
other at risk
0
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
event definition
No subjects were enrolled onto groups beyond Dose level 1 because the dose escalation was not triggered over the course of the study.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice