NCT00867529 · STUDY IN CONTEXT

Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma

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

Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.

Source null

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secondary · POSTED

Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. 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

Source null

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secondary · POSTED

Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.

Source null

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secondary · POSTED

Number of patients experiencing graft rejection and/or graft failure

Source null

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secondary · POSTED

Median time from transplant to engraftment.

Source null

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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-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id: NCT00867529
trial label: Rituximab in Treating Patients Undergoing Donor Peripheral Blood Stem Cell Transplant for Relapsed or Refractory B-cell Lymphoma
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: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0000
source section id
NCT00867529-om-0000
source outcome index
0
endpoint
Disease Relapse Rate
endpoint definition
Number of patients with relapsed/progressive disease post-transplant. The effectiveness of pre- and post-transplant rituximab in decreasing the rate of relapse will be evaluated.
time origin
At 18 months
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-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0001
source section id
NCT00867529-om-0001
source outcome index
1
endpoint
Incidence and Severity of Acute and Chronic GVHD Evaluated Per an Adapted Version of Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0
endpoint definition
Number of patients who developed acute/chronic GVHD post-transplant. A chronic GVHD diagnosis ≥1 manifestation that is distinctive for chronic GVHD, as opposed to acute GVHD. 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
time origin
Through day +100 after transplant
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-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0002
source section id
NCT00867529-om-0002
source outcome index
2
endpoint
Overall Survival and Progression-free Survival
endpoint definition
Number of patients surviving and number of patients surviving without progressive/relapsed disease, post-transplant.
time origin
At 6 months and then every year thereafter, up to 18 months
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-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0003
source section id
NCT00867529-om-0003
source outcome index
3
endpoint
Rate of Graft Rejection and Graft Failure
endpoint definition
Number of patients experiencing graft rejection and/or graft failure
time origin
18 Months
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-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0004
source section id
NCT00867529-om-0004
source outcome index
4
endpoint
Time to Engraftment
endpoint definition
Median time from transplant to engraftment.
time origin
18 Months
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

arms

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0000
arm key
OG000
arm label
Treatment (Rituximab Pre- and Post-transplant)
regimen
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00867529-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0001
arm key
OG000
arm label
Treatment (Rituximab Pre- and Post-transplant)
regimen
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00867529-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0002
arm key
OG000
arm label
Treatment (Rituximab Pre- and Post-transplant)
regimen
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00867529-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0003
arm key
OG000
arm label
Treatment (Rituximab Pre- and Post-transplant)
regimen
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00867529-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
outcome key
om-0004
arm key
OG000
arm label
Treatment (Rituximab Pre- and Post-transplant)
regimen
Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity. rituximab: Given IV peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies
analyzed count
63
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00867529-om-0004#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric-refractory-07b44757
nct id
NCT00867529
harm key
EG000
source section id
NCT00867529-ae
event group key
EG000
event group label
Treatment (Rituximab Pre- and Post-transplant)
serious affected
5
serious at risk
63
other affected
15
other at risk
63
frequency threshold
5
collection period
AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
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