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NCT00217425 · FLOW

Participant flow

Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms · Source last updated 2023-06-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
    id
    FG000
    title
    Treatment (A-CHOP Followed by MA)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Patient ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The first patient was accrued on September 14, 2006.
Complete source fields
groups
  1. description
    Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 \[max. 2 mg\]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
    id
    FG000
    title
    Treatment (A-CHOP Followed by MA)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Never started treatment
    2. reasons
      1. group Id
        FG000
        num Subjects
        5
      type
      Patient ineligible
    3. reasons
      1. group Id
        FG000
        num Subjects
        13
      type
      Lack of Efficacy
    4. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other complicating disease
    7. reasons
      1. group Id
        FG000
        num Subjects
        4
      type
      Other
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        44
      type
      Treated
    3. achievements
      1. group Id
        FG000
        num Subjects
        39
      type
      Eligible and Treated
    4. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Overall Study
recruitment Details
The first patient was accrued on September 14, 2006.

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Preserved source evidence · Not medical advice