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← Childhood Hodgkin Lymphoma

NCT01427881 · STUDY IN CONTEXT

Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.

Source null

→

secondary · POSTED

Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.

Source null

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secondary · POSTED

Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.

Source null

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secondary · POSTED

The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.

This data was not collected.

→

secondary · POSTED

Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.

Source null

→

secondary · POSTED

Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.

Source null

→

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

FACT · Graft Failure

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT01427881
qol key
qol-0009
source section id
NCT01427881-om-0009
source outcome index
9
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Graft Failure
measure definition
Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.
time frame
By greater than or equal to 28 days post-transplant
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-hodgkin-lymphoma-pediatric
nct id
NCT01427881
trial label
Cyclophosphamide for Prevention of Graft-Versus-Host Disease After Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Hematological Malignancies
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0000
    source section id
    NCT01427881-om-0000
    source outcome index
    0
    endpoint
    Chronic GVHD Requiring Systemic Immunosuppressive Treatment
    endpoint definition
    Chronic GVHD will be defined by National Institutes of Health (NIH) criteria and requiring systemic treatment. A reduction in the cumulative incidence of GVHD from \~35% to \~15% at 1 year would represent a reasonable goal. A sample size of 42 patients provides 90% power to observe such a difference with one-side 5% type-1 error.
    time origin
    At 1 year after transplantation
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0001
    source section id
    NCT01427881-om-0001
    source outcome index
    1
    endpoint
    Donor Engraftment
    endpoint definition
    Donor engraftment is defined as the count (percent) of patients with full donor chimerism. Full donor chimerism is defined as at least 95% donor CD3 cells in peripheral blood.
    time origin
    At day 28
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0002
    source section id
    NCT01427881-om-0002
    source outcome index
    2
    endpoint
    Grades II-IV and III-IV Acute GVHD
    endpoint definition
    Grades II-IV and III-IV GVHD will be assessed with the use of cumulative incidence plots.
    time origin
    Through day +100 post-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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0003
    source section id
    NCT01427881-om-0003
    source outcome index
    3
    endpoint
    Duration of Systemic Immunosuppressive Treatment
    endpoint definition
    The need for additional immunosuppressive treatment with agents other than those used for prophylaxis, the reasons for their administration (acute GVHD, chronic GVHD, or other reasons) and the duration of its administration will be determined. Patients will be monitored to determine the duration of systemic immunosuppressive treatment. Primary and secondary treatment of acute GVHD and withdrawal of systemic immunosuppressive treatment will be assessed with the use of cumulative incidence plots.
    time origin
    Up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    This data was not collected.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0004
    source section id
    NCT01427881-om-0004
    source outcome index
    4
    endpoint
    Persistent or Recurrent Malignancy After HCT
    endpoint definition
    Recurrent or progressive malignancy will be assessed with the use of cumulative incidence plots. Recurrent malignancy will be defined by hematologic criteria. Recurrent malignancy will also be defined as any unplanned medical intervention designed to prevent progression of malignant disease in patients who have molecular, cytogenetic or flow-cytometric evidence of malignant cells after transplantation.
    time origin
    At 2 years
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0005
    source section id
    NCT01427881-om-0005
    source outcome index
    5
    endpoint
    Non-relapse Mortality
    endpoint definition
    Defined as death in the absence of recurrent or progressive malignancy after HCT. Non-relapse morality will be assessed with the use of cumulative incidence plots. This secondary endpoint will be characterized and presented as a cumulative incidence.
    time origin
    At 2 years
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    regimen
    PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126. cyclophosphamide: Given IV cyclosporine: Given IV peripheral blood stem cell transplantation: Undergo allogeneic PBSCT total-body irradiation: Undergo TBI fludarabine phosphate: Given IV busulfan: Given IV allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT
    analyzed count
    43
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01427881-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    harm key
    EG000
    source section id
    NCT01427881-ae
    event group key
    EG000
    event group label
    Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)
    serious affected
    22
    serious at risk
    43
    other affected
    40
    other at risk
    43
    frequency threshold
    0
    collection period
    For all-cause mortality: 1 year after transplant For adverse events and serious adverse events, not mortality, will be monitored and recorded through the time of discharge from the transplant center
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric
    nct id
    NCT01427881
    qol key
    qol-0009
    source section id
    NCT01427881-om-0009
    source outcome index
    9
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Graft Failure
    measure definition
    Descriptive statistics will be used to assess the incidence of primary graft failure and secondary graft failure. Primary graft failure is defined as failure to achieve a sustained neutrophil count of \>= 500/uL by \>= 28 days post-transplant. Secondary graft failure is defined as the decline in neutrophil count to \< 500/uL after achieving engraftment which is unrelated to infection or drug effect and is unresponsive to stimulation by growth factors.
    time frame
    By greater than or equal to 28 days post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice