Mantle Cell Lymphoma, Non-Hodgkin's Lymphoma
Conditions
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.
Interventions
DRUGThalidomide
100-300 mg capsule taken by mouth once daily.
Sponsors
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Up to five years | OS is defined as the elapsed time from start of treatment until death or date of censoring. |
| Response Rate (RR) | Up to five years | Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment. |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A - CR+Thalidomide 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.
Thalidomide: 100-300 mg capsule taken by mouth once daily. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Group A - CR+Thalidomide |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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).
Time frame: Up to five years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A - CR+Thalidomide | Progression-free Survival (PFS) | NA years |
Secondary
Overall Survival (OS)
OS is defined as the elapsed time from start of treatment until death or date of censoring.
Time frame: Up to five years
Population: Results not reported due to participant confidentiality.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A - CR+Thalidomide | Overall Survival (OS) | NA years |
Secondary
Percentage 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.
Time frame: Up to five years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A - CR+Thalidomide | Percentage of Participants Experiencing Treatment-Emergent Adverse Events | NA percentage of participants |
Secondary
Response Rate (RR)
Response rate is defined as the percentage of participants whose cancer shrinks or disappears after treatment.
Time frame: Up to five years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A - CR+Thalidomide | Response Rate (RR) | NA percentage of participants |