Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myelo

Draft scope assessment: unclear. Attached because the study's own record describes recurrent 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

Number of patients surviving without relapsed/progressive disease

Source null

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secondary · POSTED

Relapse/Progression defined as: Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies. Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .

Source null

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secondary · POSTED

Number of patients surviving one year post-autograft

Source null

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secondary · POSTED

aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.

Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.

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secondary · POSTED

Number of patients with non-relapse mortalities.

Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.

→

secondary · POSTED

Number of patients with donor engraftment.

Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.

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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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id: NCT01008462
trial label: Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myelo
applicability: unclear
applicability note: Attached because the study's own record describes recurrent 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: 6
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0000
source section id
NCT01008462-om-0000
source outcome index
0
endpoint
Event-Free Survival (EFS)
endpoint definition
Number of patients surviving without relapsed/progressive disease
time origin
1 Year post-autograft
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population 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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0001
source section id
NCT01008462-om-0001
source outcome index
1
endpoint
Number of Patients With Relapsed/Progressive Disease
endpoint definition
Relapse/Progression defined as: Nodes, liver, and/or spleen ≥50% increased or new by physical exam / imaging studies. Circulating lymphocytes ≥50% increased by morphology and/or flow cytometry. Richter's transformation by lymph node biopsy .
time origin
1 year post-autograft
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0002
source section id
NCT01008462-om-0002
source outcome index
2
endpoint
Overall Survival
endpoint definition
Number of patients surviving one year post-autograft
time origin
1 year post-autograft
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population 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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0003
source section id
NCT01008462-om-0003
source outcome index
3
endpoint
Number of Patients With Grade II-IV Acute Graft-versus-Host-Disease and/or Chronic Extensive Graft-versus-Host-Disease
endpoint definition
aGVHD The diagnosis of aGVHD is identified through various stages and grading of the disease related to Skin (Rash), Gut (Diarrhea, Nausea/vomiting and/or anorexia) and the liver (Bilirubin) assessed by severity and grading scale outlined in the section Grafts vs Hosts by Sullivan (1999). GVHD Grades Grade I: 1-2 Skin Rash; No gut or liver involvement Grade II: Stage 1-3 Skin rash; Stage 1 gut and/or stage 1 liver involvement Grade III: Stage 2-4 gut involvement and/or stage 2-4 liver involvement with or without rash Grade IV: Pattern and severity of GVHD similar to grade 3 with extreme constitutional symptoms or death CGVHD The diagnosis of cGVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
time origin
1 year post-allograft,
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Two patients are not evaluable for Graft-versus-Host-Disease due to disease progression; they failed the study and did not receive the allogeneic transplantation.
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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0004
source section id
NCT01008462-om-0004
source outcome index
4
endpoint
Non-relapse Mortality (NRM)
endpoint definition
Number of patients with non-relapse mortalities.
time origin
200 days and 1 Year post-allograft
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0005
source section id
NCT01008462-om-0005
source outcome index
5
endpoint
Number of Patients Who Engrafted
endpoint definition
Number of patients with donor engraftment.
time origin
Day 84 post-allograft
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
Two patients are not evaluable for GVHD due to disease progression; they failed the study and did not receive the allogeneic transplantation.
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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0000
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0001
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0002
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
16
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0003
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0004
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
outcome key
om-0005
arm key
OG000
arm label
Treatment (Autologous HCT, Donor HCT)
regimen
Allogeneic Bone Marrow Transplantation: Undergo donor HCT Allogeneic Hematopoietic Stem Cell Transplantation: Undergo donor HCT Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSC transplant Autologous-Allogeneic Tandem Hematopoietic Stem Cell Transplantation: Undergo autologous-donor tandem HCT Carmustine: Given IV Cyclophosphamide: Given IV Cytarabine: Given IV Etoposide: Given IV Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative study Melphalan: Given IV Mycophenolate Mofetil: Given PO Peripheral Blood Stem Cell Transplantation: Undergo donor HCT Tacrolimus: Given IV or PO Total-Body Irradiation: Undergo TBI
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01008462-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01008462
harm key
EG000
source section id
NCT01008462-ae
event group key
EG000
event group label
Treatment (Autologous HCT, Donor HCT)
serious affected
1
serious at risk
16
other affected
5
other at risk
16
frequency threshold
0
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; All-Cause Mortality: Conditioning through 1 Year.
event definition
Source null
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