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

NCT02507336 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 20150402
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mantle Cell Lymphoma; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Survival (OS)

  Up to five years

• Response Rate (RR)

  Up to five years

• Percentage of Participants Experiencing Treatment-Emergent Adverse Events

  Up to five years

Study Arms (3)

Group A - CR+Thalidomide

EXPERIMENTAL

Patients who achieved complete response (CR) in 20030165 and continue to receive maintenance Thalidomide. Patients in Group A will receive daily oral thalidomide (THALOMID®) as per standard of care and THALOMID® REMS™ guidelines. Patients will continue with thalidomide (THALOMID®) as per standard of care guidelines, until progression of disease, discontinuation due to toxicity, death or study withdrawal. Patients will receive annual clinical/laboratory evaluations.

Drug: Thalidomide

Group B - CR+No Thalidomide

NO INTERVENTION

Patients who achieved complete response (CR) in 20030165, but are not receiving maintenance Thalidomide. Patients will receive annual clinical/laboratory evaluations.

Group C - PD or Expired

NO INTERVENTION

All other patients enrolled in 20030165 who expired or experienced disease progression (PD). Patients will be followed annually for survival.

Interventions

Thalidomide DRUG

100-300 mg capsule taken by mouth once daily.

Also known as: Thalomid

Group A - CR+Thalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related 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.

  PMID: 20038221 BACKGROUND

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Lymphoma, Non-Hodgkin

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

To protect participant privacy and maintain confidentiality, results will not be reported.

Results Point of Contact

• Title: Izidore Lossos MD
• Organization: University of Miami

ilossos@med.miami.edu

+1 (305) 2434785

Study Officials

• Izidore Lossos, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: July 23, 2015
• Study Start: November 24, 2015
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)