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Clinical Trial NCT06867536 (GLOHRT-01) for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Lymphoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Hypofractionation Radiotherapy in Combination with Glofitamab in Relapsed/refractory Diffuse B-cell Lymphoma with Baseline High Tumor Burden (GLOHRT-01) Phase 2 40 Cell Therapy

Not yet recruiting
Clinical Trial NCT06867536 (GLOHRT-01) is designed to study Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Lymphoma. This Phase 2 interventional study is not yet recruiting. Enrollment is planned to begin on April 1, 2025 until the study accrues 40 participants. Led by Liling Zhang, this study is expected to complete by August 31, 2028. The latest data from ClinicalTrials.gov was last updated on March 18, 2025.
Brief Summary
Glofitamab has shown efficacy and safety in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and has been approved for marketing in China. However, in patients with baseline high tumor burden, the complete response (CR) rate is relatively lower compared with patients without. There is still a need to improve the efficacy of glofitamab in patients with high tumor burden. Pre...Show More
Official Title

A Prospective, Single Arm, Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hypofractionation Radiotherapy in Combination with Glofitamab in Relapsed/refractory Diffuse B-cell Lymphoma with Baseline High Tumor Burden

Conditions
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Lymphoma
Other Study IDs
  • GLOHRT-01
  • UHCT241108
NCT ID Number
NCT06867536
Start Date (Actual)
2025-04-01
Last Update Posted
2025-03-18
Completion Date (Estimated)
2028-08-31
Enrollment (Estimated)
40
Study Type
Interventional
PHASE
Phase 2
Status
Not yet recruiting
Keywords
DLBCL
Glofitamab
radiotherapy
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGlofitamab
Utilizing intensity-modulated radiation therapy (IMRT); the radiation field follows the principles of involved site radiation therapy (ISRT). Total RT dose is 30 Gy/6 fraction, once daily, starting 8 days before Obinutuzumab pretreatment. An initial 1000 mg dose of Obinutuzumab will be administered as pretreatment 7 days prior to the first Glofitamab step-up dose Glofitamab is administered intravenously as step-up d...Show More
Glofitamab + Obinutuzumab
Obinutuzumab An initial 1000 mg dose of obinutuzumab will be administered as pretreatment 7 days prior to the first glofitamab step-up dose Glofitamab: Glofitamab was administered intravenously as step-up doses on day 8 (2.5 mg) and day 15 (10 mg) of cycle 1, followed by a dose of 30 mg on day 1 of cycles 2 through 8, maximum of 12 cycles (Q3W). The efficacy is evaluated after 2 cycles of glofitamab. Those with dis...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Complete remission rate
defined as the percentage of patients whose best overall response was a CR according to the 2014 Lugano Response Criteria (Cheson, et al. 2014); as determined by the investigator
From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Best response rate
defined as the proportion of patients whose best overall response is a PR or CR using 2014 Lugano Response Criteria (Cheson, et al. 2014)
From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
DoCR
defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first,. This will be evaluated using investigator assessment based on the 2014 Lugano Classification (Cheson, et al. 2014).
from the initial occurrence of a documented CR until documented disease progression or death due to any cause, assessed up to 48 months
PFS
defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be assessed by the investigator, using the 2014 Lugano classification (Cheson et al. 2014
the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 48 months
OS
defined as the time from the first study treatment to the date of death from any cause.
the time from the first study treatment to the date of death from any cause, assessed up to 48 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Signed informed consent.
  • Aged 18-75 years at the time of signing the informed consent, willing to follow and able to complete all study procedures.
  • Expected survival ≥ 12 weeks.
  • ECOG performance status score of 0-2 points ;
  • Patients with CD20-positive DLBCL confirmed by pathological histology; (unspecified DLBCL, HGBCL, PMBCL, FL-transformed DLBCL).
  • R/R DLBCL who have received at least one line of systemic treatment (including at least 2 cycles of rituximab-containing immunochemotherapy).
  • Baseline high tumor burden, defined as tumor diameter > 6 cm and/or TMTV > 128.7 mL .
  • HIV test results were negative at screening, except for the following: HIV-positive patients who have been receiving stable antiretroviral therapy and CD4 count ≥ 200/µL before enrollment Patients with undetectable viral load can be enrolled.
  • Women of childbearing age with negative urine or blood pregnancy test within 7 days before enrollment need to agree to take effective contraceptive measures during treatment and follow-up.

  • Individuals who have drug allergies or metabolic disorders to the drugs in this protocol.
  • Previous recipients of allogeneic organ transplants.
  • Individuals who received systemic immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) of the drug.
  • Anti-cancer drug treatment within 28 days before the start of treatment
  • Prior radiotherapy in the mediastinum/pericardium area; radiation therapy for non-target lesion sites is allowed.
  • History of severe or extensive cardiovascular disease.
  • Recent major surgery (within 4 weeks before the start of Cycle 1), excluding diagnostic surgeries.
  • Currently suffering from active CNS lymphoma.
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Current or previous history of concurrent Waldenström's macroglobulinemia.
  • Known active infection at the time of enrollment in the study.
  • Immune-related adverse events that appeared during prior immunotherapy: ≥Grade 3 adverse events, except for Grade 3 endocrine diseases controlled by alternative therapies. Grade 1 or 2 adverse events that did not return to baseline levels after stopping treatment.
  • History of autoimmune diseases (long-standing or well-controlled autoimmune diseases, hypothyroidism, immune thrombocytopenic purpura, and well-controlled Type I diabetes are excluded).
  • Abnormal coagulation function: INR or PT >1.5× upper limit of normal (ULN), PTT or aPTT >1.5× ULN.
  • Suspected or latent tuberculosis (confirmed by positive IFNγ release test)
  • Active hepatitis B virus (HBV) infection/positive HCV RNA test for hepatitis C virus (HCV)/HIV seropositive.
  • Previously suffered from other invasive malignancies, excluding early-stage cervical cancer, basal cell carcinoma of the skin, and thyroid cancer .
  • Pregnant or breastfeeding, or planning to become pregnant during the study period or within 18 months after pre-treatment with obinutuzumab or within 2 months after the last dose of glofitamab (whichever is longer).
  • Other concurrent uncontrolled medical conditions that, in the investigator's opinion, would affect the patient's participation in the study.
Liling Zhang logoLiling Zhang
Study Responsible Party
Liling Zhang, Sponsor-Investigator, chief physician, Huazhong University of Science and Technology
Study Central Contact
Contact: Liling Zhang, 15871725926, [email protected]
No location data.