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Thalidomide for Mantle Cell Lymphoma

Phase 2

Waitlist Available

Led By Izidore Lossos, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to five years

Awards & highlights

Study Summary

This trial is providing long-term follow-up and/or maintenance thalidomide therapy to patients enrolled in 20030165.

Eligible Conditions

Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to five years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to five years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to five years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Overall Survival (OS)

Therapeutic procedure

Response Rate (RR)

Side effects data

From 2021 Phase 4 trial • 93 Patients • NCT03122431

60%

Only sensory peripheral neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

SLE/Cutaneous Lupus With Thalidomide

Inactive SLE With Standard Dose of HCQ

Inactive SLE With Reduced Dose of HCQ

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Group A - CR+ThalidomideExperimental Treatment1 Intervention

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.

Group II: Group B - CR+No ThalidomideActive Control1 Intervention

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

Group III: Group C - PD or ExpiredActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thalidomide

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor

899 Previous Clinical Trials

409,680 Total Patients Enrolled

Izidore Lossos, MDPrincipal InvestigatorUniversity of Miami

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have signed up for this clinical trial thus far?

"At present, this study is not currently taking on new participants. It was initially posted on November 24th 2015 and last updated in September 14th 2022. However, if you are searching for other research opportunities there are 1780 studies actively enrolling patients with mantle cell lymphoma (MCL) or 28 trials utilizing Thalidomide that require enrolment."

Answered by AI

Has any previous research explored the potential of Thalidomide?

"At the moment, 28 experiments involving Thalidomide are currently ongoing. 10 of these tests have reached Phase 3 while 876 clinical trial centres around the world offer this medication to their patients. Of particular note is Mishawaka, Indiana which hosts several trials for Thalidomide."

Answered by AI

Are there currently any open enrollments for this research project?

"This trial is currently closed to new participants. It was initially posted in November of 2015 and last edited on September 14th 2022. If you are seeking additional studies, there are 1780 trials actively recruiting for mantle cell lymphoma (MCL) and 28 clinical experiments searching for Thalidomide patients."

Answered by AI

What potential risks have been observed when utilizing Thalidomide?

"Our team's assessment of Thalidomide safety is a 2, as the medication has gone through Phase 2 clinical trials with some evidence to suggest its security but no data yet verifying efficacy."

Answered by AI