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Completed

NCT Number: NCT02507336

Long-Term Followup and/or Thalidomide Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

The study seeks to provide long-term follow-up and/or to offer continued maintenance thalidomide (THALOMID) therapy to those patients enrolled in 20030165. Patients will be followed until withdrawal of consent, or death.

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Key information

Conditions

Mantle Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Non-Hodgkin's Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Enrolled on the 20030165 clinical trial.
  • Ability to understand and willingness to sign a written informed consent document.

Exclusion criteria

  • Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).
  • Uncontrolled, intercurrent serious illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and/or cardiac arrhythmia likely in the judgment of the PI to interfere with clinical study requirements.
  • Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.

Treatment and study plan

thalidomide

Drug

100-300 mg capsule taken by mouth once daily.

Other names: Thalomid

Primary outcomes

  1. Progression-free Survival (PFS)

    Time frame: Up to five years

    PFS is defined as the length of time, during and after treatment, until documented disease progression or death (by any cause, in the absence of progression).

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to five years

    OS is defined as the elapsed time from start of treatment until death or date of censoring.

  2. Response Rate (RR)

    Time frame: Up to five years

    Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment.

  3. Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    Time frame: Up to five years

    Treatment emergent adverse events will be assessed by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Long-term Follow-up and/or Continued Thalidomide (THALOMID®) Maintenance Therapy for Patients Enrolled on Clinical Trial 20030165

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2015
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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