Trial Outcomes & Findings for Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma (NCT NCT00505921)
NCT ID: NCT00505921
Last Updated: 2011-11-16
Results Overview
Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
2 years
Results posted on
2011-11-16
Participant Flow
Recruitment period: 3/11/2003 to 10/27/2009. All participants were registered at UT MD Anderson Cancer Center
Eight patients of those twenty-seven registered failed to mobilize an adequate number of stem cells for an autologous transplant and were taken off the study.
Participant milestones
| Measure |
Campath-1H
3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Campath-1H
3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
|
|---|---|
|
Overall Study
Ineligible
|
1
|
|
Overall Study
Failed to Mobilize
|
8
|
Baseline Characteristics
Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Campath-1H
n=27 Participants
3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
44 years
FULL_RANGE 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Analysis was per protocol. Nine participants were not eligible for treatment therefore were excluded from analysis.
Progression-free survival defined as the number of participants without evidence of progression or death after 2 years from stem cell transplant.
Outcome measures
| Measure |
Campath-1H
n=18 Participants
3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
|
|---|---|
|
Participant Progression Free Survival at 2 Years
|
15 participants
|
Adverse Events
Campath-1H
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Campath-1H
n=18 participants at risk
3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.
Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)
Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0.
|
|---|---|
|
Cardiac disorders
hypertension
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Cardiac disorders
low blood pressure
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Cardiac disorders
Tachycardia
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Infections and infestations
fatigue
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Infections and infestations
fevers
|
16.7%
3/18 • Number of events 3 • 5 years and 8 months
|
|
General disorders
Flu-like symptoms-other
|
16.7%
3/18 • Number of events 3 • 5 years and 8 months
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
9/18 • Number of events 9 • 5 years and 8 months
|
|
Gastrointestinal disorders
nausea
|
83.3%
15/18 • Number of events 16 • 5 years and 8 months
|
|
Gastrointestinal disorders
Esophagitis
|
61.1%
11/18 • Number of events 12 • 5 years and 8 months
|
|
Gastrointestinal disorders
abdominal pain
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Renal and urinary disorders
increased creatinine
|
27.8%
5/18 • Number of events 5 • 5 years and 8 months
|
|
Renal and urinary disorders
cystitis
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Hepatobiliary disorders
Hepatic Alkaine Phos
|
22.2%
4/18 • Number of events 4 • 5 years and 8 months
|
|
Hepatobiliary disorders
ALT- Transaminase
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Hepatobiliary disorders
AST-Tranaminase
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Hepatobiliary disorders
increased bilirubin
|
11.1%
2/18 • Number of events 2 • 5 years and 8 months
|
|
Infections and infestations
neutropenia infection
|
16.7%
3/18 • Number of events 3 • 5 years and 8 months
|
|
Infections and infestations
infection
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Nervous system disorders
involuntary movement
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Nervous system disorders
neurological other complaints
|
16.7%
3/18 • Number of events 3 • 5 years and 8 months
|
|
General disorders
insomnia
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonitis
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary other
|
5.6%
1/18 • Number of events 1 • 5 years and 8 months
|
|
Skin and subcutaneous tissue disorders
skin rash
|
16.7%
3/18 • Number of events 3 • 5 years and 8 months
|
Additional Information
Issa F. Khouri, MD / Associate Professor
UT MD Anderson Cancer Center
Phone: 713-792-8848
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place