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NCT02797470 · OUTCOME

Percentage of Participants Who Achieve a Timely Engraftment

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant · Source last updated 2026-05-18

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

Measure
MEAN
Unit
percentage of participants who achieve a
Interval / dispersion
95% Confidence Interval
Time frame
1 month post-transplant

What was measured

Timely engraftment is defined as a persistent an absolute neutrophil count (ANC) of at least 500 cells/mm3 and a platelet count of at least 20,000 cells/mm3 for at least 3 days

Groups in this outcome

Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio

Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio

Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio

Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio5
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio4
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio2

Reported measurements

Source class 1
Values in percentage of participants who achieve a · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio60Not reported14.794.7Not reported
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio75Not reported19.499.4Not reported
Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio100Not reported15.8100Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        14.7
        upper Limit
        94.7
        value
        60
      2. group Id
        OG001
        lower Limit
        19.4
        upper Limit
        99.4
        value
        75
      3. group Id
        OG002
        lower Limit
        15.8
        upper Limit
        100
        value
        100
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      2
    units
    Participants
description
Timely engraftment is defined as a persistent an absolute neutrophil count (ANC) of at least 500 cells/mm3 and a platelet count of at least 20,000 cells/mm3 for at least 3 days
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Carmustine: 300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens. Cytarabine: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Etoposide: VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens. Laboratory Biomarker Analysis: Correlative studies Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells Melphalan: 140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens. Peripheral Blood Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
    id
    OG000
    title
    Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:0 Ratio
  2. description
    Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
    id
    OG001
    title
    Treatment (Anti-HIV Gene Transduced CD34+ Cells): 1:1 Ratio
  3. description
    Patients receive BEAM regimen administered as standard of care comprising carmustine on day -6, cytarabine BID on days -5 to -2, etoposide BID on days -5 to -2, and melphalan on day -1. Patients undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells over 1 hour. Autologous Hematopoietic Stem Cell Transplantation: Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
    id
    OG002
    title
    Treatment (Anti-HIV Gene Transduced CD34+ Cells): 5:1 Ratio
param Type
MEAN
reporting Status
POSTED
time Frame
1 month post-transplant
title
Percentage of Participants Who Achieve a Timely Engraftment
type
PRIMARY
unit Of Measure
percentage of participants who achieve a

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Preserved source evidence · Not medical advice