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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507336
• Other study ID #: 20150402
• Status: Completed
• Phase: Phase 2
• Start date: November 24, 2015
• Est. completion date: August 2, 2023

Study information

• Verified date: August 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: August 2, 2023
• Est. primary completion date: August 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Enrolled on the 20030165 clinical trial.

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

Exclusion Criteria:

1. Patients who were discontinued from 20030165 for any reason prior to the completion of protocol-specified treatment (e.g. withdrawal of consent).

2. 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.

3. Psychiatric illness/condition likely in the judgment of the PI to limit compliance with clinical study requirements.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• Thalidomide
100-300 mg capsule taken by mouth once daily.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lossos IS, Hosein PJ, Morgensztern D, Coleman F, Escalon MP, Byrne GE Jr, Rosenblatt JD, Walker GR. High rate and prolonged duration of complete remissions induced by rituximab, methotrexate, doxorubicin, cyclophosphamide, vincristine, ifosfamide, etoposide, cytarabine, and thalidomide (R-MACLO-IVAM-T), a modification of the National Cancer Institute 89-C-41 regimen, in patients with newly diagnosed mantle cell lymphoma. Leuk Lymphoma. 2010 Mar;51(3):406-14. doi: 10.3109/10428190903518345. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	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).	Up to five years
Secondary	Overall Survival (OS)	OS is defined as the elapsed time from start of treatment until death or date of censoring.	Up to five years
Secondary	Response Rate (RR)	Response rate is defined as the percentage of patients whose cancer shrinks or disappears after treatment.	Up to five years
Secondary	Proportion of Participants Experiencing Treatment-Emergent Adverse Events	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.	Up to five years