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NCT01044745 · STUDY IN CONTEXT

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

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

Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.

Source null

→

secondary · POSTED

Estimated using Kaplan-Meier estimator.

Source null

→

secondary · POSTED

Estimated using Kaplan-Meier estimator.

Source null

→

secondary · POSTED

Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.

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-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
nct id
NCT01044745
trial label
Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer
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
4
harms Count
1
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0000
    source section id
    NCT01044745-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Grades II-IV Acute GVHD
    endpoint definition
    Determined with death as a competing risk. Defined and staged using the 1994 consensus conference modifications of the Glucksberg criteria.
    time origin
    At day 100
    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-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0001
    source section id
    NCT01044745-om-0001
    source outcome index
    1
    endpoint
    Event-free Survival
    endpoint definition
    Estimated using Kaplan-Meier estimator.
    time origin
    From the date of transplant with relapse/progression or death as censored events, up to 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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0002
    source section id
    NCT01044745-om-0002
    source outcome index
    2
    endpoint
    Overall Survival
    endpoint definition
    Estimated using Kaplan-Meier estimator.
    time origin
    From the date of transplant with death from any cause as a censored event, up to 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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0003
    source section id
    NCT01044745-om-0003
    source outcome index
    3
    endpoint
    Transplant-related Mortality (TRM)
    endpoint definition
    Transplant-related mortality (TRM) defined as any mortality after transplantation except mortality from relapsed disease - Reported as a simple percentage.
    time origin
    At 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
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Rituximab and Allogeneic HCT Transplant)
    regimen
    CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044745-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Rituximab and Allogeneic HCT Transplant)
    regimen
    CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044745-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Rituximab and Allogeneic HCT Transplant)
    regimen
    CONDITIONING REGIMEN: Cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Rituximab IV days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Allogeneic hematopoietic stem cell transplantation on day 0. laboratory biomarker analysis: Correlative studies graft versus host disease prophylaxis/therapy: Undergo graft versus host disease prophylaxis/therapy cyclophosphamide: Given PO or IV fludarabine phosphate: Given IV busulfan: Given IV total-body irradiation: Undergo TBI graft-versus-tumor induction therapy: Undergo graft-versus-tumor induction therapy immunosuppressive therapy: Undergo immunosuppressive therapy
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044745-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Rituximab and Allogeneic HCT Transplant)
    regimen
    CONDITIONING REGIMEN: Patients receive one of the following conditioning regimens as per the transplant physician: cyclophosphamide and TBI; targeted busulfan and fludarabine; reduced-dose busulfan and fludarabine; or fludarabine and TBI. GRAFT-VERSUS-HOST DISEASE PROPHYLAXIS: Patients receive rituximab IV on days -6, 1, 8, and 15 and anti-thymocyte globulin IV over 6-8 hours on days -3 to -1. Patients also receive tacrolimus IV continuously and then PO beginning on day -1 and continuing until day 150 followed by a taper until day 180 and mycophenolate mofetil PO or IV twice daily on days -1 to 60. TRANSPLANTATION: Patients undergo allogeneic hematopoietic stem cell transplantation on day 0. rituximab: Given IV mycophenolate mofetil: Given IV or PO tacrolimus: Given IV anti-thymocyte globulin: Given IV allogeneic hematopoietic stem cell transplantation laboratory biomarker analysis: Correlative studies graft versus host disease prophyla
    analyzed count
    18
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01044745-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-cutaneous-t-cell-lymphomas-zolinza-26c1ead9
    nct id
    NCT01044745
    harm key
    EG000
    source section id
    NCT01044745-ae
    event group key
    EG000
    event group label
    Treatment (Rituximab and Allogeneic HCT Transplant)
    serious affected
    10
    serious at risk
    20
    other affected
    16
    other at risk
    20
    frequency threshold
    5
    collection period
    Source null
    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