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← Rituxan Hycela: refractory Chronic Lymphocytic Leukemia (first-line) after prior therapy

NCT00789776 · STUDY IN CONTEXT

Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolim

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

Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

primary · POSTED

CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

primary · POSTED

Number of patients who developed acute GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL 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 with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades 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 with extreme constitutional symptoms or death

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

primary · POSTED

Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression.

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

primary · POSTED

Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts \>2 weeks and is refractory to growth factor support.

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

secondary · POSTED

Number of subjects surviving post-transplant.

One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.

→

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

FACT · Number of Participants Who Experienced Graft Failure

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00789776
qol key
qol-0004
source section id
NCT00789776-om-0004
source outcome index
4
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Number of Participants Who Experienced Graft Failure
measure definition
Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts \>2 weeks and is refractory to growth factor support.
time frame
Day 100
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
nct id
NCT00789776
trial label
Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation, and Donor Bone Marrow Transplant Followed by Donor Natural Killer Cell Therapy, Mycophenolate Mofetil, and Tacrolim
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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0000
    source section id
    NCT00789776-om-0000
    source outcome index
    0
    endpoint
    Number of Participants With Dose Limiting Toxicities
    endpoint definition
    Defined as having at least one of the following adverse events, independent of the attribution to the Natural Killer cell infusion: grade IV infusional toxicity (based on the Adapted Common Toxicity Criteria); grade IV regimen-related toxicity (based on Adapted Common Toxicity Criteria); grade IV acute Graft-Versus-Host Disease; non-relapse mortality.
    time origin
    Day 35 (28 days after NK cell infusion)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0001
    source section id
    NCT00789776-om-0001
    source outcome index
    1
    endpoint
    Number of Participants With Relapsed Disease
    endpoint definition
    CML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever greater than 38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. AML, ALL \>5% marrow blasts by morphologic or flow cytometric, or appearance of extramedullary disease. CLL ≥1 of: Physical exam/Imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
    time origin
    At 1 year
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0002
    source section id
    NCT00789776-om-0002
    source outcome index
    2
    endpoint
    Number of Participants With Grades III-IV Acute GVHD
    endpoint definition
    Number of patients who developed acute GVHD post-transplant. aGVHD Stages Skin: a maculopapular eruption involving \< 25% BSA a maculopapular eruption involving 25 - 50% BSA generalized erythroderma generalized erythroderma with bullous formation and often with desquamation Liver: bilirubin 2.0 - 3.0 mg/100 mL bilirubin 3 - 5.9 mg/100 mL bilirubin 6 - 14.9 mg/100 mL 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 with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades 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 with extreme constitutional symptoms or death
    time origin
    Day 100
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0003
    source section id
    NCT00789776-om-0003
    source outcome index
    3
    endpoint
    Number of Non-relapse Participant Mortalities
    endpoint definition
    Defined as death in any patient for whom there has not been a diagnosis of relapse or disease progression.
    time origin
    Day 200
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0004
    source section id
    NCT00789776-om-0004
    source outcome index
    4
    endpoint
    Number of Participants Who Experienced Graft Failure
    endpoint definition
    Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts \>2 weeks and is refractory to growth factor support.
    time origin
    Day 100
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0005
    source section id
    NCT00789776-om-0005
    source outcome index
    5
    endpoint
    Number of Subjects Surviving Post-transplant.
    endpoint definition
    Number of subjects surviving post-transplant.
    time origin
    Up to 1 year
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 2.5 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    5
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    outcome key
    om-0005
    arm key
    OG001
    arm label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    regimen
    CONDITIONING: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on days -6 and -5. Patients undergo total-body irradiation on day -1. DONOR BONE MARROW TRANSPLANTATION: Patients undergo donor bone marrow transplantation on day 0. POST-TRANSPLANTATION IMMUNOSUPPRESSION: Patients receive cyclophosphamide IV over 1 hour on day 3 and mycophenolate mofetil PO TID on days 4 - 40, followed by a taper until day 84 in the absence of GVHD. Patients also receive tacrolimus IV continuously or IV QD over 1-2 hours or PO BID on days 4 - 84, followed by a taper until day 180 in the absence of GVHD. NK CELL INFUSION: Patients undergo donor lymphocyte infusion of 5.0 x 10\^6/kg NK cells on day 7. Allogeneic Bone Marrow Transplantation: Undergo donor bone marrow transplantation Laboratory Biomarker Analysis: Correlative studies
    analyzed count
    35
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00789776-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    harm key
    EG000
    source section id
    NCT00789776-ae
    event group key
    EG000
    event group label
    Dose 1 (2.5 x 10^6/kg NK Cells)
    serious affected
    1
    serious at risk
    5
    other affected
    4
    other at risk
    5
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; 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-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    harm key
    EG001
    source section id
    NCT00789776-ae
    event group key
    EG001
    event group label
    Dose 2 (5.0 x 10^6/kg NK Cells)
    serious affected
    0
    serious at risk
    35
    other affected
    19
    other at risk
    35
    frequency threshold
    0
    collection period
    AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200; 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-chronic-lymphocytic-leukemia-rituxan-hycela-fc081759
    nct id
    NCT00789776
    qol key
    qol-0004
    source section id
    NCT00789776-om-0004
    source outcome index
    4
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Number of Participants Who Experienced Graft Failure
    measure definition
    Graft failure is defined as grade IV thrombocytopenia and neutropenia after Day +21 that lasts \>2 weeks and is refractory to growth factor support.
    time frame
    Day 100
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    One subject aborted transplant after conditioning due to donor ineligibility. This subject was counted towards accrual but not evaluated with respect to outcome measures.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice