Hodgkin Lymphoma Clinical Trials

Find Hodgkin Lymphoma Clinical Trials Near You

Pembrolizumab and GVD With ctDNA-guided Consolidation in Patients With Relapsed or Refractory Classic Hodgkin Lymphoma: A Multicenter Phase 2 Study of the University of California Hematologic Malignancies Consortium

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Procedure, Radiation, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single arm, open-label, multicenter, phase II study of pembrolizumab (pembro), gemcitabine, vinorelbine, and liposomal doxorubicin (GVD) in patients with relapsed or refractory classic Hodgkin lymphoma (cHL) with response-adapted consolidation. This study will investigate using circulating tumor DNA (ctDNA) at pre-determined time points using Foresight CLARITY LDT, an ultra-sensitive liquid biopsy platform that detects Minimal residual disease (MRD) in patients with B-cell lymphomas using the phased variant enrichment and sequencing technology (PhasEDq) to determine response to study interventions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years.

• Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma).

• Participants must have relapsed or refractory disease after no more than one line of systemic therapy. First line therapy must have included doxorubicin.

• At least one site of FDG-avid disease on PET/CT that is ≥ 1.5 cm in diameter for nodal disease or ≥ 1.0 cm in diameter if extranodal disease.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky ≥ 50%).

• Demonstrates adequate organ function as defined below:

∙ Absolute neutrophil count (ANC) ≥ 1.0 X 10\^9/ L (1000/microliter (mcL), growth factors permitted).

‣ Platelets ≥ 75 X 10\^9 / L (75,000/mcL, platelet transfusion independent).

‣ Total bilirubin ≤ 1.5 x institutional upper limit of normal, unless elevated due to Gilbert's syndrome.

‣ Aspartate aminotransferase (AST) / (SGOT) ≤3 x institutional upper limit of normal.

‣ Alanine aminotransferase (ALT) / (SGPT) ≤3 x institutional upper limit of normal.

‣ Creatinine clearance (CrCl, calculated) ≥ 40 mL/min/1.73 m\^2, calculated using the Cockcroft-Gault equation.

• For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

• Individuals with a history of hepatitis C virus (HCV) infection must have been treated with sustained virologic response. For individuals with HCV infection who are currently on treatment, participants are eligible if there is an undetectable HCV viral load.

• Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.

⁃ Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

⁃ Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before start of trial therapy. A female is considered to not be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if the participants meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). The result of the urine or serum pregnancy test must be negative in order to administer initiate trial therapy. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is a potential risk for adverse effects in the unborn child secondary to treatment of the study participant with trial therapy.

⁃ Ability to understand and willingness to sign a written informed consent document.

Locations
United States
California
University of California Davis
NOT_YET_RECRUITING
Davis
University of California San Francisco-Fresno
NOT_YET_RECRUITING
Fresno
University of California Irvine
NOT_YET_RECRUITING
Irvine
University of California, San Diego
NOT_YET_RECRUITING
La Jolla
Unversity of California, Los Angeles
NOT_YET_RECRUITING
Los Angeles
University of California, San Francisco
RECRUITING
San Francisco
Contact Information
Primary
UCSF Hematopoietic Malignancies Clinical Trial Recruitment
HDFCCC.Heme@ucsf.edu
877-827-3222
Backup
Nickole Criner
cancertrials@ucsf.edu
877-827-3222
Time Frame
Start Date: 2026-08-18
Estimated Completion Date: 2034-03-31
Participants
Target number of participants: 38
Treatments
Experimental: Treatment (Pembrolizumab + GVD)
All participants receive 2, 21-day cycles of 200 mg Pembrolizumab (pembro) on day 1 of each cycle (pembro) and 1000mg Gemcitabine, 20mg/m\^2 of Vinorelbine, Liposomal doxorubicin 15 mg/m2 (GVD) on days 1 and 8 of each cycle for up to 2 cycles. Pegfilgrastim is administered on day 8 or 9 of each cycle. FDG-PET/CT imaging and Foresight CLARITY LDT ctDNA response after 2 cycles will determine if participants are eligible for an additional 2 cycles of pembro + GVD or salvage therapy and ASCT. Participants may be able to qualify for consolidation without ASCT (pembro and/or 30 Gy ISRT) depending on response. Radiographic response after 4 cycles will be conducted to determine eligibility for consolidation without ASCT for participants with CR or standard of care salvage therapy and ASCT, for participants with partial response (PR), stable disease (SD), or progressive disease (PD) after a second administration of pembro+GVD. Participants are followed for up to 5 years.
Sponsors
Collaborators: Natera, Inc., UC Hematologic Malignancies Consortium (UCHMC), Gateway for Cancer Research, Foresight Diagnostics, Inc.
Leads: Michael Spinner, MD

This content was sourced from clinicaltrials.gov