Trial Outcomes & Findings for Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma (NCT NCT00290433)
NCT ID: NCT00290433
Last Updated: 2020-09-23
Results Overview
Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From registration to disease progression or death, up to 3 years
Results posted on
2020-09-23
Participant Flow
Recruitment period: September 17, 2003 to May 8, 2009. All recruitment done at The University of Texas MD Anderson Cancer Center.
Of the 55 participants registered, two participants were found not to be eligible prior to start of study therefore are excluded from trial details.
Participant milestones
| Measure |
HCVIDDOXIL Regimen
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
HCVIDDOXIL Regimen
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
Overall Study
Disease Progression
|
13
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Non-Compliance
|
1
|
|
Overall Study
Congestive Heart Failure
|
1
|
|
Overall Study
Transplant in CR
|
5
|
|
Overall Study
Unrelated Infection/Death
|
1
|
Baseline Characteristics
Efficacy of the HCVIDDOXIL Regimen in Patients With Newly Diagnosed Peripheral T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
HCVIDDOXIL Regimen
n=53 Participants
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
Age, Continuous
|
54 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From registration to disease progression or death, up to 3 yearsPopulation: Of the 53 participants, \*6 participants\* were not evaluable for response due to either no measurable disease (1) or early departure from study for adverse events (5)
Percentage of participants out of total treated alive with disease progression 3 years following registration. Progression-free survival (PFS) was measured from the date of study registration to the date of documented disease progression or death of any cause.
Outcome measures
| Measure |
HCVIDDOXIL Regimen
n=47 Participants
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
3 Year Progression-Free Survival Rate
|
30 percentage of participants
Interval 18.0 to 44.0
|
Adverse Events
HCVIDDOXIL Regimen
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HCVIDDOXIL Regimen
n=53 participants at risk
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
Infections and infestations
massive cytomegalovirus infection
|
1.9%
1/53 • Number of events 1 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
Other adverse events
| Measure |
HCVIDDOXIL Regimen
n=53 participants at risk
Cycle 1: Cyclophosphamide 300 mg/m\^2 intravenous (IV) twice a day on Days 1-3. Mesna 600 mg/m\^2 continuous IV Days 1-3. Doxil 25 mg/m\^2 IV over 1 hour on Day 2. Vincristine 1.4 mg/m\^2 IV on Days 4 and 11. Dexamethasone 40 mg Iv or oral on Days 1 - 4 and 11 - 14.
Cycle 2: Methotrexate 200 mg/m\^2 over 2 hours on Day 1 and 800 mg/m\^2 over 22 hours on day 1. Cytarabine 3 Gm/m\^2 IV twice a day on Days 2 and 3.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
79.2%
42/53 • Number of events 42 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Blood and lymphatic system disorders
Anemia
|
86.8%
46/53 • Number of events 46 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
86.8%
46/53 • Number of events 46 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
39.6%
21/53 • Number of events 21 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
General disorders
Fever
|
66.0%
35/53 • Number of events 35 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Infections and infestations
Infectious Disease
|
35.8%
19/53 • Number of events 19 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
General disorders
Fatigue
|
75.5%
40/53 • Number of events 40 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Hepatobiliary disorders
Liver Toxicities
|
39.6%
21/53 • Number of events 21 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Gastrointestinal disorders
Constipation
|
35.8%
19/53 • Number of events 19 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Nervous system disorders
Dizziness
|
35.8%
19/53 • Number of events 19 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
35.8%
19/53 • Number of events 19 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.8%
11/53 • Number of events 11 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis
|
30.2%
16/53 • Number of events 16 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
General disorders
Edema
|
67.9%
36/53 • Number of events 36 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.9%
10/53 • Number of events 10 • Adverse events were assessed from the initiation of the regimen through the end of the chemotherapy cycle, up to 3 years.
|
Additional Information
Christopher Flowers/Chair, Lymphoma-Myeloma
The University of Texas (UT) MD Anderson Cancer Center
Phone: 713-745-6095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place