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← Keytruda: refractory Hodgkin Lymphoma

NCT01780662 · STUDY IN CONTEXT

Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma

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 because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.

The first 9 out of 16 patients enrolled with relapsed/refractory HL in a phase 1 dose finding study of brentuximab vedotin in combination with gemcitabine, were used in determining MTD

→

primary · POSTED

The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.

All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

→

primary · POSTED

The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

→

secondary · POSTED

The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.

All eligible patients in phase 1, dose level 2 (N=13). 3 patients in phase 1 were not given dose level 2.

→

secondary · POSTED

The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.

All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine).4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

→

secondary · POSTED

Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.

For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.

→

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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
nct id
NCT01780662
trial label
Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma
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
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
2
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0000
    source section id
    NCT01780662-om-0000
    source outcome index
    0
    endpoint
    Maximum Tolerated Dose (MTD) for Brentuximab Vedotin
    endpoint definition
    MTD was determined as the maximum dose at which fewer than one-third of patients experience Dose Limiting Toxicities (DLT) as assessed by National Cancer Institute (NCI) CTCAE v 4.0 during Cycle 1 of therapy. Gemcitabine was administered on days 1 and 8 of a 21 day cycle at a fixed dose. Brentuximab vedotin was investigated at a starting dose of 1.4 mg/kg administered on day 1 and escalated if tolerated.
    time origin
    During cycle 1 of protocol therapy (21 days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The first 9 out of 16 patients enrolled with relapsed/refractory HL in a phase 1 dose finding study of brentuximab vedotin in combination with gemcitabine, were used in determining MTD
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0001
    source section id
    NCT01780662-om-0001
    source outcome index
    1
    endpoint
    Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
    endpoint definition
    The number of eligible patients assigned to receive brentuximab vedotin in combination with gemcitabine that experienced CTC Version 4, grade 3 or higher adverse events during Phase 1 and Phase 2.
    time origin
    13 months from first dose
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients (N=45). One patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0002
    source section id
    NCT01780662-om-0002
    source outcome index
    2
    endpoint
    The Number of Patients With Relapsed or Refractory HL Who Achieved Complete Response (CR)
    endpoint definition
    The number of patients who experienced complete Response (CR) within the first four cycles. By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
    time origin
    After 4 cycles (21 days per cycle) of protocol therapy
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine). 4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0003
    source section id
    NCT01780662-om-0003
    source outcome index
    3
    endpoint
    The Number of Patients Who Had Disease Response Assessed by Deauville Scales Among Those in Phase I With Dose Level 2.
    endpoint definition
    The Deauville five-point scale was used to assess the number of participants with complete response (CR) and partial response (PR). A lower score indicates a better outcome. Scores of 1-3 represent CR and 4-5 represent PR.
    time origin
    Up to 13 months from first dose
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients in phase 1, dose level 2 (N=13). 3 patients in phase 1 were not given dose level 2.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0004
    source section id
    NCT01780662-om-0004
    source outcome index
    4
    endpoint
    Percentage of Patients Who Achieved Overall Response (OR) as Measured by Complete Response (CR) and Partial Response (PR)
    endpoint definition
    The percentage of patients who experienced complete Response (CR) within the first four cycles.By modern response criteria, those with partial response (PR) or stable disease with all target lesions with Deauville scores \<=3 after cycle 4 are also considered as CR. Patients were assessed after treatment with four cycles of gemcitabine with brentuximab vedotin. CR was only reported for Dose level 2 across both phases of study.
    time origin
    After 4 cycles (21 days per cycle) of protocol therapy
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    All eligible patients (N=42) at Dose Level 2 (brentuximab vedotin 1.8 mg/kg with gemcitabine).4 patients were excluded. 3 patients did not receive dose level 2 and 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0005
    source section id
    NCT01780662-om-0005
    source outcome index
    5
    endpoint
    The Number of Patients Who Had Successful Peripheral Blood Stem Cell (PBSC) Collection
    endpoint definition
    Successful PBSC collection was defined as a collection of more than 2x10\^6 CD34 positive cells.
    time origin
    From 1 to 5 cycles
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    For 21 of the eligible 45 subjects, PBSC collection was not attempted during protocol therapy, either because stem cells had been collected prior to study enrollment, or no autologous stem cell transplant was planned. 1 patient was ineligible due to exceeding the prescribed interval between disease evaluation and study entry.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
    regimen
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    analyzed count
    9
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Dose 1.4mg/kg (Phase I)
    regimen
    Patients who were enrolled in Phase I and took dose 1.4mg/kg
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Dose 1.8mg/kg (Phase I + Phase II)
    regimen
    Patients who were enrolled in Phase I and Phase II and took dose 1.8mg/kg
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0001#groups/OG001
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
    regimen
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0002#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
    regimen
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0003#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
    regimen
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    analyzed count
    42
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0004#groups/OG000
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Treatment (Brentuximab Vedotin, Gemcitabine Hydrochloride)
    regimen
    Patients receive brentuximab vedotin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 100 minutes on days 1 and 8. Treatment repeats every 21 days for up to 15 more courses in the absence of disease progression or unacceptable toxicity. Patients with CR after any course may go off protocol therapy for stem cell transplant. Brentuximab Vedotin: Given IV Gemcitabine Hydrochloride: Given IV
    analyzed count
    24
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01780662-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    harm key
    EG000
    source section id
    NCT01780662-ae
    event group key
    EG000
    event group label
    Dose1.4mg/kg
    serious affected
    3
    serious at risk
    3
    other affected
    3
    other at risk
    3
    frequency threshold
    0
    collection period
    From first dose up to 13 months.
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    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-hodgkin-lymphoma-pediatric-keytruda-bc1ce30f
    nct id
    NCT01780662
    harm key
    EG001
    source section id
    NCT01780662-ae
    event group key
    EG001
    event group label
    Dose 1.8mg/kg
    serious affected
    37
    serious at risk
    42
    other affected
    28
    other at risk
    42
    frequency threshold
    0
    collection period
    From first dose up to 13 months.
    event definition
    Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution, via expedited reporting (NCI AdEERs / CAeRs). The "AE Other" table reflects all CTCAEs collected excluding those that were reported as SAEs. Ineligible patients are excluded from reporting of adverse events.
    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