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← recurrent Langerhans Cell Histiocytosis

NCT03096782 · STUDY IN CONTEXT

Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma

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 days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days.

Source null

→

secondary · POSTED

Number of participants that were in remission post transplant.

Source null

→

secondary · POSTED

Number of participants alive 1 year post transplant.

One participant died 5 months post transplant.

→

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-langerhans-cell-histiocytosis-recurrent-1f951e33
nct id
NCT03096782
trial label
Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma
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
3
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0000
    source section id
    NCT03096782-om-0000
    source outcome index
    0
    endpoint
    Time to Engraftment
    endpoint definition
    Number of days from transplant when participants achieved engraftment measure by ANC of 0.5 for three consecutive days.
    time origin
    Up to 12 months after transplant
    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-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0001
    source section id
    NCT03096782-om-0001
    source outcome index
    1
    endpoint
    Disease-free Survival
    endpoint definition
    Number of participants that were in remission post transplant.
    time origin
    Up to12 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0002
    source section id
    NCT03096782-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Number of participants alive 1 year post transplant.
    time origin
    Up to 12 months after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One participant died 5 months post transplant.
    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-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Chemotherapy Plus Cord Blood Transplant
    regimen
    GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03096782-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Chemotherapy Plus Cord Blood Transplant
    regimen
    GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
    analyzed count
    6
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03096782-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Chemotherapy Plus Cord Blood Transplant
    regimen
    GVHD PROPHYLAXIS: All patients receive mycofenolate mofetil IV over 2 hours or PO BID on days -3 with a taper beginning on day 100 in the absence of GVHD, tacrolimus IV or PO starting on day -2 for 6 months in the absence of GVHD, and filgrastim-sndz SC QD starting on day 0 until white blood count begins to recover. Anti-Thymocyte Globulin: Given IV Busulfan: Given IV Clofarabine: Given IV Filgrastim-sndz: Given SC Fludarabine: Given IV Mycophenolate Mofetil: Given IV or PO Rituximab: Given IV Tacrolimus: Given IV Total-Body Irradiation: Undergo total body irradiation Umbilical Cord Blood Transplantation: Undergo cord blood transplant
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03096782-om-0002#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-langerhans-cell-histiocytosis-recurrent-1f951e33
    nct id
    NCT03096782
    harm key
    EG000
    source section id
    NCT03096782-ae
    event group key
    EG000
    event group label
    Chemotherapy and Cord Blood Transfusion
    serious affected
    1
    serious at risk
    6
    other affected
    6
    other at risk
    6
    frequency threshold
    0
    collection period
    All-Cause Mortality was monitored up to 12 months post-transplant. Serious and Other Adverse Events were monitored up to Day 100 post-transplant.
    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