Trial Outcomes & Findings for Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (NCT NCT00506129)
NCT ID: NCT00506129
Last Updated: 2020-12-29
Results Overview
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
33 participants
Primary outcome timeframe
Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Results posted on
2020-12-29
Participant Flow
Recruitment Period: September 26, 2003 to November 05, 2012. All recruitment done at The University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Fludarabine + Melphalan With PBPC
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
|
|---|---|
|
Overall Study
STARTED
|
33
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
Fludarabine + Melphalan With PBPC
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
|
|---|---|
|
Overall Study
Disease Progression/Relapse
|
15
|
|
Overall Study
Death
|
7
|
Baseline Characteristics
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Fludarabine + Melphalan With PBPC
n=33 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
|
|---|---|
|
Age, Continuous
|
55 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
Outcome measures
| Measure |
Fludarabine + Melphalan With PBPC
n=33 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
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|---|---|
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Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
CR Prior to Transplant
|
6 participants
|
|
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Partial Response (PR)
|
0 participants
|
|
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Complete Response (CR) Converted Post Transplant
|
19 participants
|
|
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Stable Disease (SD)
|
0 participants
|
|
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Progressive Disease (PD)
|
16 participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression, followed up to 5 years post transplantPopulation: Baseline to disease progression, followed up to 5 years post transplant (assess at 100 days, every 3 months for 2 years, then once a year for at least 3 years)
OS was defined as the time from transplantation to the date of death from any cause or last follow up, measured in days.
Outcome measures
| Measure |
Fludarabine + Melphalan With PBPC
n=33 Participants
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
|
|---|---|
|
Average Overall Survival (OS) Length
|
1207 Days
Interval 17.0 to 1825.0
|
Adverse Events
Fludarabine + Melphalan With PBPC
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fludarabine + Melphalan With PBPC
n=33 participants at risk
Fludarabine 25 mg/m\^2 intravenous (IV) daily for 5 days prior to allogeneic peripheral blood progenitor cell (PBPC) , Melphalan 70 mg/m\^2 IV daily for 2 days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
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|---|---|
|
Cardiac disorders
Primary graft failure with autologous reconstitution
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
Cardiac Edema
|
18.2%
6/33 • Number of events 6 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
Cardiac Function
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Vascular disorders
Hypertension
|
21.2%
7/33 • Number of events 7 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
Congestive heart failure
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
Chest pain
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
pericarditis
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Cardiac disorders
tachycardia
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
fever
|
24.2%
8/33 • Number of events 8 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
fatigue
|
15.2%
5/33 • Number of events 5 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
fluid overload: Edema
|
30.3%
10/33 • Number of events 10 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
rigors
|
12.1%
4/33 • Number of events 4 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Metabolism and nutrition disorders
anorexia
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
diarrhea
|
81.8%
27/33 • Number of events 27 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
mucositis
|
54.5%
18/33 • Number of events 18 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
flatulence
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
nausea
|
97.0%
32/33 • Number of events 32 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
constipation
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
dry mouth
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
Upper gastrointestinal disorder, GvHD
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
pain
|
9.1%
3/33 • Number of events 4 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Gastrointestinal disorders
vomit
|
15.2%
5/33 • Number of events 5 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
bladder
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
renal failure
|
24.2%
8/33 • Number of events 8 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
frequency, urine
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
hemorrhagic cystitis
|
9.1%
3/33 • Number of events 4 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
Acute Kidney Disease (renal disorder), dialysis
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
General disorders
abdomen pain
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Renal and urinary disorders
dysuria
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Hepatobiliary disorders
transaminitis
|
87.9%
29/33 • Number of events 29 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Investigations
increase T bilirubin
|
18.2%
6/33 • Number of events 6 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Infections and infestations
infection
|
51.5%
17/33 • Number of events 37 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Blood and lymphatic system disorders
neutropenic fever
|
9.1%
3/33 • Number of events 3 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Metabolism and nutrition disorders
hyperglycemia
|
15.2%
5/33 • Number of events 5 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Nervous system disorders
drowsiness
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Nervous system disorders
dizziness
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Nervous system disorders
headache
|
39.4%
13/33 • Number of events 13 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Psychiatric disorders
anxiety
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Musculoskeletal and connective tissue disorders
weakness, generalized
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Musculoskeletal and connective tissue disorders
muscular wasting
|
3.0%
1/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Musculoskeletal and connective tissue disorders
myalgias
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Musculoskeletal and connective tissue disorders
bone pain
|
15.2%
5/33 • Number of events 5 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
6.1%
2/33 • Number of events 2 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Respiratory, thoracic and mediastinal disorders
hiccoups
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
15.2%
5/33 • Number of events 5 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Respiratory, thoracic and mediastinal disorders
shortness of breath
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Injury, poisoning and procedural complications
Acute Graft versus Host Disease
|
3.0%
1/33 • Number of events 1 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
|
Skin and subcutaneous tissue disorders
rash
|
21.2%
7/33 • Number of events 7 • Adverse events collected till 30 days following end of active treatment (the date of the stem cell infusion).
|
Additional Information
Chitra M. Hosing, Professor, Stem Cell Transplantation
University of Texas (UT) MD Anderson Cancer Center
Phone: 1-877-MDA-6789
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place