Trial Outcomes & Findings for High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors (NCT NCT00536601)
NCT ID: NCT00536601
Last Updated: 2021-04-22
Results Overview
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
174 participants
Primary outcome timeframe
From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 years
Results posted on
2021-04-22
Participant Flow
Participant milestones
| Measure |
Acute Leukemia
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
21
|
71
|
65
|
11
|
|
Overall Study
COMPLETED
|
6
|
21
|
71
|
65
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High-Dose Chemotherapy With or Without Total-Body Irradiation Followed by Autologous Stem Cell Transplant in Treating Patients With Hematologic Cancer or Solid Tumors
Baseline characteristics by cohort
| Measure |
Acute Leukemia
n=6 Participants
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 Participants
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 Participants
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 Participants
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 Participants
Patients diagnosed with and treated for a solid tumor
|
Total
n=174 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
0-39 years
|
1 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
|
Age, Customized
40-59 years
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
|
Age, Customized
60-75 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
68 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
71 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
103 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
172 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
159 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
21 participants
n=7 Participants
|
71 participants
n=5 Participants
|
65 participants
n=4 Participants
|
11 participants
n=21 Participants
|
174 participants
n=8 Participants
|
|
Risk Group
High
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
80 Participants
n=8 Participants
|
|
Risk Group
Standard
|
0 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
79 Participants
n=8 Participants
|
|
Risk Group
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From the date of transplantation to the date of first observed disease progression or death due to any cause, assessed up to 12 yearsPopulation: Each disease strata presents PFS for each conditioning regimen defined in the protocol
Assessed using the product-limit based Kaplan Meier method. Additionally, a 95% confidence interval of the distribution will be computed.
Outcome measures
| Measure |
Acute Leukemia
n=6 Participants
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 Participants
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 Participants
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 Participants
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 Participants
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
BuCy
|
33 Proportion of participants
Interval 0.0 to 71.0
|
14 Proportion of participants
Interval 0.0 to 40.0
|
22 Proportion of participants
Interval 7.0 to 38.0
|
—
|
—
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
CBV
|
—
|
43 Proportion of participants
Interval 17.0 to 69.0
|
37 Proportion of participants
Interval 23.0 to 52.0
|
—
|
—
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
VCp
|
—
|
—
|
0 Proportion of participants
Interval 0.0 to 0.0
|
—
|
43 Proportion of participants
Interval 6.0 to 80.0
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
Mel120
|
—
|
—
|
—
|
22 Proportion of participants
Interval 2.0 to 41.0
|
—
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
Mel200
|
—
|
—
|
—
|
13 Proportion of participants
Interval 3.0 to 22.0
|
—
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
CyTtCp
|
—
|
—
|
—
|
—
|
0 Proportion of participants
Interval 0.0 to 0.0
|
|
Progression-free Survival (PFS) Distribution of Patients With HL, NHL, and MM for Each Disease-specific High-dose Therapy Regimen, Estimate Provided for 10-yr PFS (Median Follow-up Time in Survivors)
TtC1500
|
—
|
—
|
—
|
—
|
50 Proportion of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 100 days after transplantationToxicities will be reported using descriptive statistics.
Outcome measures
| Measure |
Acute Leukemia
n=6 Participants
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 Participants
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 Participants
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 Participants
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 Participants
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
Regimen-related Toxicity Grade 2-4 in Any Organ (Measured by Bearman Score, Values Range From 0 (None) to 4 (Fatal))
|
1 Participants
|
9 Participants
|
19 Participants
|
31 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: At 100 daysResponse rates will be reported using descriptive statistics.
Outcome measures
| Measure |
Acute Leukemia
n=6 Participants
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 Participants
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 Participants
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 Participants
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 Participants
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
Response Rate (Complete Remission)
|
5 Participants
|
17 Participants
|
54 Participants
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Patients are followed up to maximum of 12 yearsAssessed using the product-limit based Kaplan Meier method.
Outcome measures
| Measure |
Acute Leukemia
n=6 Participants
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 Participants
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 Participants
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 Participants
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 Participants
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
Overall Survival, Presented as the Estimate at 10-yrs (Median Follow-up Time in Survivors)
|
33 Proportion of participants
Interval 0.0 to 71.0
|
61 Proportion of participants
Interval 40.0 to 82.0
|
45 Proportion of participants
Interval 33.0 to 57.0
|
39 Proportion of participants
Interval 27.0 to 51.0
|
46 Proportion of participants
Interval 16.0 to 75.0
|
Adverse Events
Acute Leukemia
Serious events: 1 serious events
Other events: 0 other events
Deaths: 4 deaths
Hodgkin Lymphoma
Serious events: 9 serious events
Other events: 0 other events
Deaths: 8 deaths
Non-Hodgkin Lymphoma
Serious events: 19 serious events
Other events: 0 other events
Deaths: 41 deaths
MM/Amyloid
Serious events: 31 serious events
Other events: 0 other events
Deaths: 45 deaths
Solid Tumors
Serious events: 3 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Acute Leukemia
n=6 participants at risk
Patients diagnosed with and treated for acute myeloid leukemia or acute lymphoblastic leukemia
|
Hodgkin Lymphoma
n=21 participants at risk
Patients diagnosed with and treated for Hodgkin Lymphoma
|
Non-Hodgkin Lymphoma
n=71 participants at risk
Patients diagnosed with and treated for Non-Hodgkin Lymphoma
|
MM/Amyloid
n=65 participants at risk
Patients diagnosed with or treated for multiple myeloma or amyloidosis
|
Solid Tumors
n=11 participants at risk
Patients diagnosed with and treated for a solid tumor
|
|---|---|---|---|---|---|
|
General disorders
Regimen Related Toxicity
|
16.7%
1/6 • Number of events 1 • SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
|
42.9%
9/21 • Number of events 9 • SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
|
26.8%
19/71 • Number of events 19 • SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
|
47.7%
31/65 • Number of events 31 • SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
|
27.3%
3/11 • Number of events 3 • SAE= 100 days after transplantation All cause mortality = 12 years
SAE= Regimen related toxicity grade 2-4 in any organ system (Bearman Score, range from 0 (none) to 4 (fatal)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place