Trial Outcomes & Findings for Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma (NCT NCT00255801)
NCT ID: NCT00255801
Last Updated: 2018-08-16
Results Overview
CRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
COMPLETED
PHASE2
37 participants
3 years
2018-08-16
Participant Flow
Participant milestones
| Measure |
Doxil and Targretin® (Bexarotene)
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Liposomal Doxorubicin Followed By Bexarotene in Treating Patients With Cutaneous T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Doxil and Targretin® (Bexarotene)
n=37 Participants
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
|
|---|---|
|
Age, Continuous
|
56 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 yearsCRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
Outcome measures
| Measure |
Doxil and Targretin® (Bexarotene)
n=37 Participants
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
|
|---|---|
|
Median Progression-free Survival
|
5 months
Interval 0.16 to 26.26
|
SECONDARY outcome
Timeframe: 2 yearsCRITERIA FOR THERAPEUTIC RESPONSE/OUTCOME ASSESSMENT * CT scans of chest, abdomen and pelvis for TNM stage IV patients who had positive findings prior to treatment. * CBC with Sézary cell count and/or flow cytometry in patients with Sézary syndrome. * Dermatologic responses will be determined by the Severity-Weighted Assessment Tool (SWAT), a standardized approach to measuring the extent and severity of overall skin disease in patients with CTCL Primary skin tumor assessments were made by the modified Severity-Weighted Assessment Tool (mSWAT) \[12, 13\]; the Composite Assessment of Index Lesion Severity (CA) \[9, 14\] was used a secondary scale. Progression was defined as ≥25% increase in mSWAT skin score and ≥50% increase in the sum of the products of the greatest diameters of involved lymph nodes over baseline for patients with involved lymph nodes with stage IV disease
Outcome measures
| Measure |
Doxil and Targretin® (Bexarotene)
n=37 Participants
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
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|---|---|
|
Maximum Therapeutic Response
Clinical Complete Response
|
2 Participants
|
|
Maximum Therapeutic Response
Partial Response
|
12 Participants
|
|
Maximum Therapeutic Response
Stable Disease
|
6 Participants
|
|
Maximum Therapeutic Response
Progressive Disease
|
14 Participants
|
|
Maximum Therapeutic Response
Not Evaluable
|
3 Participants
|
Adverse Events
Doxil and Targretin® (Bexarotene)
Serious adverse events
| Measure |
Doxil and Targretin® (Bexarotene)
n=37 participants at risk
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
|
|---|---|
|
Cardiac disorders
Cardiac Arrhythmia, other
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.7%
1/37 • 2 years
|
|
General disorders
Death not assoc w CTCAE term-Disease prog NOS
|
2.7%
1/37 • 2 years
|
|
General disorders
Fever (in the absence of neutropenia)
|
2.7%
1/37 • 2 years
|
|
Injury, poisoning and procedural complications
Fracture
|
2.7%
1/37 • 2 years
|
|
Gastrointestinal disorders
Gastritis (incl bile reflux gastritis)
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Inf norm ANC/gr1/2 neut-Cellulitis(skin)
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Blood
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Inf unknown ANC-Cellulitis(skin)
|
2.7%
1/37 • 2 years
|
|
Infections and infestations
Infection, other
|
13.5%
5/37 • 2 years
|
|
Investigations
Leukocytes (total WBC)
|
2.7%
1/37 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
2.7%
1/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pain - Skin
|
2.7%
1/37 • 2 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
2.7%
1/37 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulm infiltrates
|
2.7%
1/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.7%
1/37 • 2 years
|
|
General disorders
Rigors/chills
|
5.4%
2/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
2.7%
1/37 • 2 years
|
Other adverse events
| Measure |
Doxil and Targretin® (Bexarotene)
n=37 participants at risk
Patients will be treated with intravenous Doxil® every two weeks for 8 doses (16 weeks). Responses will be assessed. They will then receive Targretin® (bexarotene) orally for at least 16 weeks. Patients who achieve a CR or PR may continue on Targretin® (bexarotene) until relapse.
|
|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
29.7%
11/37 • 2 years
|
|
Investigations
White blood cells
|
24.3%
9/37 • 2 years
|
|
Investigations
Cholesterol, high
|
18.9%
7/37 • 2 years
|
|
Metabolism and nutrition disorders
Triglyceride, high
|
18.9%
7/37 • 2 years
|
|
General disorders
Fatigue
|
10.8%
4/37 • 2 years
|
|
Investigations
Neutrophils
|
10.8%
4/37 • 2 years
|
|
Investigations
Lymphopenia
|
8.1%
3/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
8.1%
3/37 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
5.4%
2/37 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
5.4%
2/37 • 2 years
|
Additional Information
Dr. David Straus
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place