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← recurrent Childhood Non-Hodgkin Lymphoma

NCT01529827 · STUDY IN CONTEXT

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

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

Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.

All treated and eligible patients

→

secondary · POSTED

Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to

All treated and eligible patients

→

secondary · POSTED

Assessed using Kaplan Meier and Proportional Hazards

All treated and eligible patients

→

secondary · POSTED

Median time to recovery of absolute neutrophil count \>=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.

All treated and eligible patients

→

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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
nct id
NCT01529827
trial label
Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0000
    source section id
    NCT01529827-om-0000
    source outcome index
    0
    endpoint
    Transplant Related Mortality (TRM)
    endpoint definition
    Day 100 transplant related mortality (TRM). An exact 95% confidence interval will be provided.
    time origin
    In the first 100 days from day 0 of transplant
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0001
    source section id
    NCT01529827-om-0001
    source outcome index
    1
    endpoint
    Clinical Response
    endpoint definition
    Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to
    time origin
    In the first 100 days from day 0 of transplant
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0002
    source section id
    NCT01529827-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival (PFS) at One Year
    endpoint definition
    Assessed using Kaplan Meier and Proportional Hazards
    time origin
    day of transplant until progression up to 5 years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0003
    source section id
    NCT01529827-om-0003
    source outcome index
    3
    endpoint
    Median Time to Neutrophil Engraftment
    endpoint definition
    Median time to recovery of absolute neutrophil count \>=500/uL for 3 consecutive days. Summarized using standard descriptive statistics along with corresponding 95% confidence intervals.
    time origin
    Day 100
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All treated and eligible patients
    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-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Reduced Intensity Allogeneic PBSCT)
    regimen
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    analyzed count
    94
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01529827-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Treatment (Reduced Intensity Allogeneic PBSCT)
    regimen
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    analyzed count
    94
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01529827-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Reduced Intensity Allogeneic PBSCT)
    regimen
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    analyzed count
    94
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01529827-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Reduced Intensity Allogeneic PBSCT)
    regimen
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    analyzed count
    94
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01529827-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-pediatric-recurrent-c5218487
    nct id
    NCT01529827
    harm key
    EG000
    source section id
    NCT01529827-ae
    event group key
    EG000
    event group label
    Treatment (Reduced Intensity Allogeneic PBSCT)
    serious affected
    17
    serious at risk
    94
    other affected
    1
    other at risk
    94
    frequency threshold
    0
    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