Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    150
  • sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
Updated on 24 January 2021

Summary

The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing regimens.

Description

This single-arm phase II study investigates the value of early FDG-PET-response adapted BV-based therapy for advanced HL. All patients will receive one cycle of BrAVD followed by an FDG-PET/CT. Patients with a negative early FDG-PET(Deauville score 1-3) will continue with five more BrAVD cycles (total six cycles) while patients with a positive FDG-PET should shift to six cycles of BrECADD.

The hypothesis is that the efficacy will be comparable to the efficacy of BEACOPPesc and BrECADD, while using the intensive chemotherapy regimen only for those patients who do not achieve a negative FDG-PET after one cycle.

The choice to assess the treatment sensitivity by PET after a single cycle of BrAVD is based on results from a recent international multicenter study comparing FDG-PET/CT after one and two cycles of ABVD chemotherapy in HL. There is no reason to suspect that FDG-PET1 should be less prognostic after BrAVD than after ABVD.

With this trial, the investigators believe they can add important information about the optimal treatment of BV-containing first-line treatment for advanced HL, and thus answer important therapeutic questions that are likely to otherwise remain unanswered even after the Echelon-1 and HD21 trials reach mature results. This relatively large single-arm phase II trial of 150 patients will allow a meaningful comparison with the BrAVD and BrECADD regimens based on modified progression-free survival (primary endpoint) and progression-free survival (secondary endpoint) respectively.

Details
Condition Advanced Hodgkin Lymphoma
Treatment radiation therapy, cyclophosphamide, etoposide, Adriamycin, dacarbazine, brentuximab vedotin, Vinblastine
Clinical Study IdentifierNCT03517137
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Previously untreated, histologically proven classical Hodgkin lymphoma
Staged by PET with diagnostic-quality CT (i.v. contrast)
Clinical stages according to Lugano 2014 and based on FDG/PET CT
Stage IIB with large mediastinal mass > 1/3 max transverse diameter thorax and/or extranodal lesion(s)
Stage III - IV
Consent to participation in translational research
Archival tumor tissue available (15 blank formalin fixed paraffin embedded tissue samples mounted on APES slides or a tissue block)
Women of child bearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the first dose of study treatment
Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 6 months after the last dose of treatment. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e. less than 1 percent per year) when used consistently and correctly
Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 6 months after the last study treatment
Absence of any medical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations

Exclusion Criteria

Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of Progressive Multifocal Leukoencenphalopathy
Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
Sensory or motor peripheral neuropathy greater than or equal to grade 2 according to CTCAE version 4.0
Any of the following cardiovascular conditions or values
within 6 months before registration
A left-ventricular ejection fraction <50 percent (at registration)
New York Heart Association (NYHA) Class III or IV heart failure
Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
symptomatic coronary heart disease (stable angina pectoris is allowed)
severe uncontrolled hypertension within 2 years before registration
Myocardial infarction
Patients with poorly controlled diabetes mellitus (HbA1c > 7.5 percent or a fasting blood sugar > 200 mg/dL)
Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to registration
Known HIV infection, chronic active hepatitis C, HBV positivity (HBsAg + patients; HBsAg -/HBcAb+/HBV DNA+ patients)
Note: HBsAg-/HBV DNA - patients are eligible; patients who are seropositive
due to vaccination are eligible
Concomitant or previous malignancies within the past 5 years with the exception of adequately treated carcinoma in situ of the cervix , nonmelanoma skin cancer
Previous treatment with anti CD30 antibodies
Known hypersensitivity to any excipient contained in Brentuximab Vedotin formulation and other study drugs. Refer to Summary Product Characteristics for list of excipients
Concurrent anti-cancer treatment or use of any investigational agent(s)
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