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NCT03384654 · OUTCOME

Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma · Source last updated 2025-05-25

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

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to 4 years 4 months

What was measured

Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported.

Analysis population: The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.

Groups in this outcome

Cohort 1: B-cell ALL (1-17 Years)

Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).

Cohort 2: T-Cell ALL (1-17 Years)

Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).

Cohort 2: T-Cell ALL (18-30 Years)

Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).

Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)

Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).

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

Analysis denominator · Participants

GroupSource count
Cohort 1: B-cell ALL (1-17 Years)7
Cohort 2: T-Cell ALL (1-17 Years)24
Cohort 2: T-Cell ALL (18-30 Years)5
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)10

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1: B-cell ALL (1-17 Years)14.3Not reported0.752.1Not reported
Cohort 2: T-Cell ALL (1-17 Years)75.0Not reported56.588.5Not reported
Cohort 2: T-Cell ALL (18-30 Years)60.0Not reported18.992.4Not reported
Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)30.0Not reported8.760.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.7
        upper Limit
        52.1
        value
        14.3
      2. group Id
        OG001
        lower Limit
        56.5
        upper Limit
        88.5
        value
        75.0
      3. group Id
        OG002
        lower Limit
        18.9
        upper Limit
        92.4
        value
        60.0
      4. group Id
        OG003
        lower Limit
        8.7
        upper Limit
        60.7
        value
        30.0
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      24
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      10
    units
    Participants
description
Percentage of participants who received an allogeneic HSCT after treatment with daratumumab were reported.
dispersion Type
90% Confidence Interval
groups
  1. description
    Participants with relapsed/refractory B-cell ALL received intrathecal methotrexate (MTX) 8 milligrams (mg): 1 to less than (\<) 2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: greater than or equal to (\>=) 9 years on Cycle 1 Day 1 (for all participants) and Cycle 2 and later Day 1 each Cycle (for CNS negative participants); for CNS positive participants: along with MTX, hydrocortisone (HC)/cytarabine (ARA-C) was administered per local standard practice; daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion weekly on Days 1, 8, 15 and 22 of Cycles 1 and 2 then every 2 weeks on Days 1, 15 of Cycle 3 to 6 and every 4 weeks on Day 1 of Cycle 7 and onward; vincristine 1.5 milligrams per meter square (mg/m\^2) IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1, then every 2 weeks on Days 1 and 15 of Cycle 2 and every 4 weeks on Day 1 of Cycle 3 and onward; prednisone 40 mg/m\^2 orally daily on Day 1 to 28 of Cycle 1 and on Day 1 to 5 of Cycle 2 onward. Participants received treatment until disease progression, unacceptable toxicity, or proceeding hematopoietic stem cell transplant after complete response (CR), whichever came first (maximum duration: 2.3 months).
    id
    OG000
    title
    Cohort 1: B-cell ALL (1-17 Years)
  2. description
    Participants with relapsed/refractory T-cell ALL received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and Cycle 1 Days 15, and 22 (CNS negative participants);for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV infusion once on Day 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 on Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Day 1 to 28 on Cycle 1; peg-asparaginase 2500 units per meter square (U/m\^2) as intramuscular (IM) injection/IV infusion on Days 2, 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 2 Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide IV 1 g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/subcutaneous (SC) on Day 16 to 19 and Days 23 to 26; 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.9 months).
    id
    OG001
    title
    Cohort 2: T-Cell ALL (1-17 Years)
  3. description
    Participants with relapsed/refractory T-cell ALL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion once weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.1 months).
    id
    OG002
    title
    Cohort 2: T-Cell ALL (18-30 Years)
  4. description
    Participants with relapsed/refractory T-cell LL in Cycle 1 received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg: \>=9 years on Cycle 1 Day 1 (all participants) and on Cycle 1 Days 15 and 22 (CNS negative participants); for CNS positive participants, along with MTX, HC/ARA-C was administered per local standard practice; daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; doxorubicin 60 mg/m\^2 IV once on Day 1 of Cycle 1; vincristine 1.5 mg/m\^2 IV injection/infusion weekly on Days 1, 8, 15 and 22 of Cycle 1; prednisone 40 mg/m\^2 as 2 doses (20 mg/m\^2 per dose) orally daily on Days 1 to 28 and peg-asparaginase 2500 U/m\^2 as IM injection/IV infusion on Days 2 and 16 of Cycle 1. In Cycle 2, participants received intrathecal MTX 8 mg: 1 to \<2 years, 10 mg: 2 to \<3 years, 12 mg: 3 to \<9 years and 15 mg:\>=9 years on Days 2 and 15 (CNS negative participants); MTX, HC/ARA-C was administered by on Days 2 and 15 per local standard practice (CNS positive participants); daratumumab 16 mg/kg IV infusion weekly on Days 1, 8, 15 and 22; MTX 5 g/m\^2 as IV once on Day 2, cyclophosphamide 1g/m\^2 once on Day 15; cytarabine 75 mg/m\^2 IV/SC on Days 16 to 19 and Days 23 to 26; and 6-mercaptopurine 60 mg/m\^2 orally daily on Days 15 to 28 (maximum duration: 2.3 months).
    id
    OG003
    title
    Cohort 2: T-Cell Lymphoblastic Leukemia (LL) (1-30 Years)
param Type
NUMBER
population Description
The all treated analysis set included all enrolled participants who received at least 1 dose of daratumumab.
reporting Status
POSTED
time Frame
Up to 4 years 4 months
title
Percentage of Participants Who Received an Allogeneic Hematopoietic Stem Cell Transplant (HSCT)
type
SECONDARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice