A Trial Comparing Chemotherapy Versus Novel Immune Checkpoint Inhibitor (Pembrolizumab) Plus Chemotherapy in Treating Relapsed/Refractory Classical Hodgkin Lymphoma

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05711628
Phase
PHASE3
Status
Withdrawn

Conditions

  • Recurrent Classic Hodgkin Lymphoma
  • Refractory Classic Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
5 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo ASCT
  • Bendamustine — DRUG
    Given IV
  • Brentuximab Vedotin — DRUG
    Given IV
  • Carboplatin — DRUG
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo PET/CT and CT
  • Etoposide — DRUG
    Given IV
  • Gemcitabine — DRUG
    Given IV
  • Ifosfamide — DRUG
    Given IV
  • Pegylated Liposomal Doxorubicin Hydrochloride — DRUG
    Given IV
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Radiation Therapy — RADIATION
    Undergo RT
  • Transplant Conditioning — OTHER
    Receive standard preparative chemotherapy regimen
  • Vinorelbine — DRUG
    Given IV

Study Details

This phase III trial compares chemotherapy versus an immune checkpoint inhibitor drug called pembrolizumab plus chemotherapy in treating patients with classical Hodgkin lymphoma that has come back (relapsed) or that does not respond to treatment (refractory). The usual approach for patients with classical Hodgkin lymphoma is treatment with standard chemotherapy, including drugs that are Food and Drug Administration (FDA)-approved. If this treatment puts a patient into remission, high dose chemotherapy and stem cell transplant may be used to increase the likelihood of a cure. Hodgkin lymphoma is capable of inhibiting the immune system from killing it. Pembrolizumab is a checkpoint inhibitor that may be able to stop this inhibition, allowing the immune system to attack the lymphoma.

Key Dates

Start date
Aug 10, 2023
Status verified
Mar 2024
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (chemotherapy regimen, HDT-ASCT)
    SALVAGE THERAPY: Patients receive 1 of 3 chemotherapy regimens as clinically indicated: 1) ifosfamide IV, carboplatin IV, and etoposide IV; 2) gemcitabine IV, vinorelbine IV, and pegylated liposomal doxorubicin IV; or 3) brentuximab vedotin IV and bendamustine IV. Patients then undergo a PET/CT scan. Patients who achieve a CR or PR proceed to HDT-ASCT. Patients who achieve SD or PD come off study treatment. HDT-ASCT: Patients undergo ASCT. Patients may also receive a standard preparative chemotherapy regimen as clinically indicated. Patients who achieve PR prior to ASCT may also undergo RT as clinically indicated. Patients who went into ASCT with PR also undergo a PET/CT scan 30 days post-transplant. MAINTENANCE THERAPY: Patients may receive brentuximab vedotin IV as clinically indicated.
  • Experimental: Arm B (chemotherapy regimens+pembrolizumab, HD-ASCT)
    SALVAGE THERAPY: Patients receive pembrolizumab IV plus 1 of 3 chemotherapy regimens specified in Arm A as clinically indicated. Patients then undergo a PET scan. Patients who achieve a CR or PR proceed to HDT-ASCT. Patients who achieve SD or PD come off study treatment. HDT-ASCT: Patients undergo ASCT. Patients may also receive a standard preparative chemotherapy regimen as clinically indicated. Patients who achieve PR prior to ASCT may also undergo RT as clinically indicated. Patients who went into ASCT with PR also undergo a PET/CT scan 30 days post-transplant. MAINTENANCE THERAPY: Patients may receive brentuximab vedotin IV as clinically indicated.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: Time from randomization to the earlier of events listed in description field, assessed up to 15 years ]

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