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← KEYTRUDA: refractory Hodgkin Lymphoma

NCT00723099 · STUDY IN CONTEXT

Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer

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

Kaplan-Meier and cumulative incidence estimates will be used.

Source null

→

secondary · POSTED

Median Time to ANC > 500

Source null

→

secondary · POSTED

descriptive

Source null

→

secondary · POSTED

median and range

Source null

→

secondary · POSTED

Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria

Source null

→

secondary · POSTED

Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria

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

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
NCT00723099
trial label
Donor Umbilical Cord Blood Transplant in Treating Patients With Hematologic Cancer
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
6
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0000
    source section id
    NCT00723099-om-0000
    source outcome index
    0
    endpoint
    Overall Survival
    endpoint definition
    Kaplan-Meier and cumulative incidence estimates will be used.
    time origin
    At 1 year
    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-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0001
    source section id
    NCT00723099-om-0001
    source outcome index
    1
    endpoint
    Median Time to ANC > 500
    endpoint definition
    Median Time to ANC > 500
    time origin
    By day 55
    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-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0002
    source section id
    NCT00723099-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Graft Failure/Rejection
    endpoint definition
    descriptive
    time origin
    By day 55
    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-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0003
    source section id
    NCT00723099-om-0003
    source outcome index
    3
    endpoint
    Time to Platelet Engraftment of > 20,000 Cells Per mm3
    endpoint definition
    median and range
    time origin
    By 6 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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0004
    source section id
    NCT00723099-om-0004
    source outcome index
    4
    endpoint
    Percent of Patients With Grade II-IV Acute Graft Versus Host Disease
    endpoint definition
    Chi-square test was used to determine percent of grade II-IV GVHD using Glucksberg criteria
    time origin
    By day 100
    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-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0005
    source section id
    NCT00723099-om-0005
    source outcome index
    5
    endpoint
    Percent of Patients With Acute GVHD Grades III-IV
    endpoint definition
    Fischer's exact test was used to determined percent of patients with acute grade III-IV GVHD by Glucksberg criteria
    time origin
    100 days
    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-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Mycophenolate Mofetil: Given IV or PO Total-Body Irradiation: Undergo TBI Umbilical Cord Blood Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Chemotherapy, Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 1 hour on days -6 to -2 and cyclophosphamide IV over 1-2 hours on day -6. Patients with low risk of graft failure (multi-agent chemotherapy in the last 3 months or history of autologous transplant) receive 200cGy TBI on day -1. Patients with high risk of graft failure receive 300 cGy TBI on day -1. UMBILICAL CORD BLOOD TRANSPLANT: Patients undergo donor umbilical cord blood infusion on day 0. IMMUNOSUPRESSIVE THERAPIES: Patients receive cyclosporine IV over 1 hour every 8-12 hours on days 0 to +180 and mycophenolate mofetil IV or PO every 8 hours on days -3 to +96. Allogeneic Hematopoietic Stem Cell Transplantation: Undergo umbilical cord blood transplant
    analyzed count
    72
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00723099-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-keytruda-7b74c3c0
    nct id
    NCT00723099
    harm key
    EG000
    source section id
    NCT00723099-ae
    event group key
    EG000
    event group label
    Treatment (Chemotherapy, Transplant)
    serious affected
    18
    serious at risk
    72
    other affected
    59
    other at risk
    72
    frequency threshold
    0
    collection period
    100 days
    event definition
    CTCAE Version 3.0
    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