Skip to content
Triangle logo TriangleGet started
← Clolar: refractory acute lymphocytic leukemia after prior therapy

NCT00105001 · STUDY IN CONTEXT

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematolog

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 grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death

Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.

→

secondary · POSTED

Percentage of NRM as estimated by cumulative incidence methods with competing risks. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198

Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.

→

secondary · POSTED

Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198

Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.

→

secondary · POSTED

Number of patients surviving, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198

Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.

→

secondary · POSTED

Number of patients with progression-free survival, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198

Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.

→

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-acute-lymphoblastic-leukemia-clolar-441ba0ad
nct id
NCT00105001
trial label
Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematolog
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
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0000
    source section id
    NCT00105001-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Grades II-IV Acute GVHD
    endpoint definition
    Number of patients with grades II-IV acute GVHD aGVHD Stages Skin: 1. a maculopapular eruption involving \< 25% BSA 2. a maculopapular eruption involving 25 - 50% BSA 3. generalized erythroderma 4. generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. bilirubin 2.0 - 3.0 mg/100 mL 2. bilirubin 3 - 5.9 mg/100 mL 3. bilirubin 6 - 14.9 mg/100 mL 4. 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 w/ visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement 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 w/ extreme constitutional symptoms or death
    time origin
    150 days after transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
    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-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0001
    source section id
    NCT00105001-om-0001
    source outcome index
    1
    endpoint
    Number of Non-Relapse Mortalities
    endpoint definition
    Percentage of NRM as estimated by cumulative incidence methods with competing risks. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    time origin
    200 days after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
    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-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0002
    source section id
    NCT00105001-om-0002
    source outcome index
    2
    endpoint
    Number of Participants Utilizing High-Dose Corticosteroids
    endpoint definition
    Number of patients utilizing high-dose corticosteroids (as a surrogate marker for reduction of acute GVHD), estimated by cumulative incidence methods. Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    time origin
    150 days after transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
    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-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0003
    source section id
    NCT00105001-om-0003
    source outcome index
    3
    endpoint
    Number of Participants Surviving Overall
    endpoint definition
    Number of patients surviving, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    time origin
    1 Year post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
    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-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0004
    source section id
    NCT00105001-om-0004
    source outcome index
    4
    endpoint
    Number of Participants Surviving Without Progression
    endpoint definition
    Number of patients with progression-free survival, estimated by cumulative incidence methods Cumulative incidence methods are the standard way to estimate incidence of an endpoint in the presence of competing risks and censoring (ref)" Here is the reference. Gooley TA, Leisenring W, Crowley J, Storer BE: Estimation of failure probabilities in the presence of competing risks: new representations of old estimators. Statistics in Medicine 18:695-706, 1999. PMID 10204198
    time origin
    2 Years post-transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Two subjects counted towards accrual but did not proceed to transplant and thus were not evaluable.
    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-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Arm I (MMF and Tacrolimus)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Arm II (MMF and Tacrolimus Alternate Schedule)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Arm III (MMF, Tacrolimus, and Sirolimus)
    regimen
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    analyzed count
    68
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Arm I (MMF and Tacrolimus)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Arm II (MMF and Tacrolimus Alternate Schedule)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Arm III (MMF, Tacrolimus, and Sirolimus)
    regimen
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    analyzed count
    68
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Arm I (MMF and Tacrolimus)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Arm II (MMF and Tacrolimus Alternate Schedule)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Arm III (MMF, Tacrolimus, and Sirolimus)
    regimen
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    analyzed count
    68
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Arm I (MMF and Tacrolimus)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    69
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Arm II (MMF and Tacrolimus Alternate Schedule)
    regimen
    Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO
    analyzed count
    71
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Arm III (MMF, Tacrolimus, and Sirolimus)
    regimen
    Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80. Fludarabine Phosphate: Given IV Total-Body Irradiation: Undergo total-body irradiation Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation Tacrolimus: Given IV or PO Mycophenolate Mofetil: Given PO Sirolimus: Given PO
    analyzed count
    68
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00105001-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    harm key
    EG000
    source section id
    NCT00105001-ae
    event group key
    EG000
    event group label
    Arm I (MMF and Tacrolimus)
    serious affected
    9
    serious at risk
    69
    other affected
    25
    other at risk
    69
    frequency threshold
    0
    collection period
    AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    harm key
    EG001
    source section id
    NCT00105001-ae
    event group key
    EG001
    event group label
    Arm II (MMF and Tacrolimus Alternate Schedule)
    serious affected
    8
    serious at risk
    71
    other affected
    22
    other at risk
    71
    frequency threshold
    0
    collection period
    AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-acute-lymphoblastic-leukemia-clolar-441ba0ad
    nct id
    NCT00105001
    harm key
    EG002
    source section id
    NCT00105001-ae
    event group key
    EG002
    event group label
    Arm III (MMF, Tacrolimus, and Sirolimus)
    serious affected
    7
    serious at risk
    68
    other affected
    25
    other at risk
    68
    frequency threshold
    0
    collection period
    AEs: From the start of conditioning to 100 Days post-transplant SAEs: From the start of conditioning to 200 Days post-transplant All-Cause Mortality: Conditioning through 1 Year
    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