Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

  • STATUS
    Recruiting
  • sponsor
    Tetraphase Pharmaceuticals, Inc.
Updated on 25 March 2021

Summary

Hodgkin Lymphoma Molecular Profiling and Clinical Outcomes in U.S. Community Oncology Practices

Description

This is an observational (non-interventional), multi-center study that will prospectively enroll patients diagnosed with, and treated for Hodgkin lymphoma. Data collection will include extraction of medical records via case report forms, self-administered patient-reported outcome questionnaires, and tissue samples (archival and newly obtained) for molecular profiling. Treatment decisions will be determined at the discretion of the treating physician(s). As the study is collecting data on real-world management of cHL, the protocol is not to influence prescribing or management practices at participating sites in any way.

Details
Condition Lymphoma
Clinical Study IdentifierTX149248
SponsorTetraphase Pharmaceuticals, Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women ≥18 years of age
Histologically confirmed diagnosis of Classical Hodgkin Lymphoma (cHL)
Patients who are treatment-naïve or are within ± 2 weeks of Day 1 of Cycle 1 of any line of therapy at time of enrollment
Patients must be within ± 2 weeks of Day 1 of the first cycle of any line of therapy to enroll; a cycle is practice-defined for chemotherapy, targeted therapy, or immunotherapy based regimens
Patients enrolled, who receive anti-cancer therapy, and who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up
Any Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status (PS)
Patients must have available medical records for the date of diagnosis of cHL
Patients must have available medical records documenting any prior treatment and treatment dates for the Hodgkin lymphoma, including chemotherapy, radiation, surgery and other anticancer therapy received
Patients must consent to use their FPFE tissue blocks, blood or serum samples, for exploratory analyses

Exclusion Criteria

Patients with unknown date of diagnosis of cHL
Patients whose prior therapy and dates of therapy (eg, surgery, radiation, or drug therapy) are unknown
Any other (non-HL) active malignancy for which the patient is receiving treatment
Patients participating in a clinical study that does not allow enrollment into a noninterventional study
At time of enrollment, patients who are receiving supportive, palliative, hospice or end-of life care only and not receiving anti-cancer therapy will be excluded
Patients enrolled who receive anti-cancer therapy, and who go on to receive only supportive, palliative, hospice, or end-of-life care remain on study and should not be discontinued from follow-up
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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