Trial Outcomes & Findings for Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma (NCT NCT00345865)

NCT ID: NCT00345865

Last Updated: 2020-07-14

Results Overview

Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

473 participants

Primary outcome timeframe

1 year

Results posted on

2020-07-14

Participant Flow

Participant milestones

Participant milestones
Measure
NHL With Irradiation
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Overall Study
STARTED
171
149
2
5
146
Overall Study
COMPLETED
171
149
2
5
146
Overall Study
NOT COMPLETED
0
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Autologous Peripheral Stem Cell Transplant in Treating Patients With Non-Hodgkin's Lymphoma or Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Total
n=473 Participants
Total of all reporting groups
Age, Categorical
<=18 years
4 Participants
n=5 Participants
13 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
17 Participants
n=8 Participants
Age, Categorical
Between 18 and 65 years
126 Participants
n=5 Participants
129 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
107 Participants
n=21 Participants
368 Participants
n=8 Participants
Age, Categorical
>=65 years
41 Participants
n=5 Participants
7 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
39 Participants
n=21 Participants
88 Participants
n=8 Participants
Sex: Female, Male
Female
53 Participants
n=5 Participants
74 Participants
n=7 Participants
1 Participants
n=5 Participants
1 Participants
n=4 Participants
54 Participants
n=21 Participants
183 Participants
n=8 Participants
Sex: Female, Male
Male
118 Participants
n=5 Participants
75 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
92 Participants
n=21 Participants
290 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
1 Participants
n=21 Participants
1 Participants
n=8 Participants
Race (NIH/OMB)
Asian
4 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
9 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
10 Participants
n=5 Participants
5 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
4 Participants
n=21 Participants
20 Participants
n=8 Participants
Race (NIH/OMB)
White
147 Participants
n=5 Participants
127 Participants
n=7 Participants
1 Participants
n=5 Participants
5 Participants
n=4 Participants
135 Participants
n=21 Participants
415 Participants
n=8 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=5 Participants
3 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
4 Participants
n=8 Participants
Race (NIH/OMB)
Unknown or Not Reported
9 Participants
n=5 Participants
12 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
3 Participants
n=21 Participants
24 Participants
n=8 Participants

PRIMARY outcome

Timeframe: 1 year

Progression is defined using the Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group.The definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Number of Participants With 1 Year Progression Free Survival
112 Participants
102 Participants
1 Participants
2 Participants
116 Participants

PRIMARY outcome

Timeframe: 2 years

Progression is determined using Response Criteria for Non-Hodgkin's Lymphoma given by NCI Sponsored International Working Group. Definition is as follows: At least a 50% increase from nadir of any previously identified abnormal node. Appearance of any new lesion during or at the end of therapy.

Outcome measures

Outcome measures
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Number of Participants With 2 Years Progression Free Survival
96 Participants
91 Participants
1 Participants
1 Participants
106 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Number of Participants With 1 Year Overall Survival
139 Participants
144 Participants
1 Participants
5 Participants
128 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Number of Participants With 2 Years Overall Survival
124 Participants
140 Participants
1 Participants
4 Participants
121 Participants

SECONDARY outcome

Timeframe: Day 42

return to ANC (absolute neutrophil count) more than 500 cells/milliliter.

Outcome measures

Outcome measures
Measure
NHL With Irradiation
n=171 Participants
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 Participants
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 Participants
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=145 Participants
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Number of Participants With Hematopoietic Recovery After Transplantation
171 Participants
147 Participants
2 Participants
5 Participants
145 Participants

Adverse Events

NHL With Irradiation

Serious events: 34 serious events
Other events: 125 other events
Deaths: 47 deaths

HL Without Irradiation

Serious events: 18 serious events
Other events: 98 other events
Deaths: 9 deaths

NHL - HIV Infected With Irradiation

Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths

NHL - HIV Infected Without Irradiation

Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths

NHL Without Radiation and Cyclophosphamide

Serious events: 0 serious events
Other events: 120 other events
Deaths: 25 deaths

Serious adverse events

Serious adverse events
Measure
NHL With Irradiation
n=171 participants at risk
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 participants at risk
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 participants at risk
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 participants at risk
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 participants at risk
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
2.3%
4/171 • Number of events 4 • 2 years
0.00%
0/149 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Respiratory, thoracic and mediastinal disorders
Hemorrhage
0.58%
1/171 • Number of events 1 • 2 years
0.00%
0/149 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Disease progression
5.3%
9/171 • Number of events 12 • 2 years
2.7%
4/149 • Number of events 4 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Relapse
7.0%
12/171 • Number of events 12 • 2 years
8.1%
12/149 • Number of events 12 • 2 years
0.00%
0/2 • 2 years
20.0%
1/5 • Number of events 1 • 2 years
0.00%
0/146 • 2 years
Respiratory, thoracic and mediastinal disorders
Pulmonary failure
0.58%
1/171 • Number of events 1 • 2 years
0.00%
0/149 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplasia
0.58%
1/171 • Number of events 1 • 2 years
0.00%
0/149 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to progression
2.3%
4/171 • Number of events 4 • 2 years
0.67%
1/149 • Number of events 1 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to relapse
4.7%
8/171 • Number of events 8 • 2 years
0.67%
1/149 • Number of events 1 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death due to multi organ failure
0.58%
1/171 • Number of events 1 • 2 years
0.67%
1/149 • Number of events 1 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.00%
0/146 • 2 years

Other adverse events

Other adverse events
Measure
NHL With Irradiation
n=171 participants at risk
Non Hodgkin's Lymphoma patients treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
HL Without Irradiation
n=149 participants at risk
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected With Irradiation
n=2 participants at risk
Non Hodgkin's Lymphoma patients infected with HIV, treated with cyclophosphamide, total body irradiation therapy, peripheral blood stem cell transplantation and G-CSF.
NHL - HIV Infected Without Irradiation
n=5 participants at risk
Patients with Hodgkin's lymphoma treated with cyclosphosphamide, carmustine, etoposide, peripheral blood stem cell transplantation and G-CSF.
NHL Without Radiation and Cyclophosphamide
n=146 participants at risk
Patients with non Hodgkin's lymphoma ineligible to receive total body irradiation because of prior radiation and are not candidates for high dose cyclophosphamide will be treated with carmustine, etoposide, cytarabine, and melphalan followed by peripheral blood stem cell transplantation and G-CSF (called BEAM conditioning).
Infections and infestations
Infection
55.0%
94/171 • Number of events 331 • 2 years
42.3%
63/149 • Number of events 187 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
40.0%
2/5 • Number of events 15 • 2 years
70.5%
103/146 • Number of events 291 • 2 years
Respiratory, thoracic and mediastinal disorders
Pneumonia
39.2%
67/171 • Number of events 160 • 2 years
35.6%
53/149 • Number of events 102 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
40.0%
2/5 • Number of events 6 • 2 years
37.7%
55/146 • Number of events 102 • 2 years
Cardiac disorders
Decreased heart function
11.7%
20/171 • Number of events 26 • 2 years
10.7%
16/149 • Number of events 21 • 2 years
0.00%
0/2 • 2 years
40.0%
2/5 • Number of events 3 • 2 years
13.7%
20/146 • Number of events 31 • 2 years
Nervous system disorders
Neuropathy
17.0%
29/171 • Number of events 39 • 2 years
8.1%
12/149 • Number of events 13 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
9.6%
14/146 • Number of events 16 • 2 years
Renal and urinary disorders
Other Kidney disorder
13.5%
23/171 • Number of events 36 • 2 years
4.0%
6/149 • Number of events 10 • 2 years
50.0%
1/2 • Number of events 2 • 2 years
40.0%
2/5 • Number of events 2 • 2 years
6.2%
9/146 • Number of events 10 • 2 years
Nervous system disorders
sensory loss
11.7%
20/171 • Number of events 26 • 2 years
2.7%
4/149 • Number of events 4 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
5.5%
8/146 • Number of events 8 • 2 years
Vascular disorders
Deep vein thrombosis
5.3%
9/171 • Number of events 10 • 2 years
5.4%
8/149 • Number of events 9 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
0.00%
0/5 • 2 years
10.3%
15/146 • Number of events 16 • 2 years
Respiratory, thoracic and mediastinal disorders
Intubation
5.3%
9/171 • Number of events 17 • 2 years
4.0%
6/149 • Number of events 8 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
4.1%
6/146 • Number of events 7 • 2 years
Vascular disorders
Thrombosis
5.8%
10/171 • Number of events 10 • 2 years
5.4%
8/149 • Number of events 9 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
0.00%
0/5 • 2 years
5.5%
8/146 • Number of events 10 • 2 years
Gastrointestinal disorders
GI bleeding
7.0%
12/171 • Number of events 13 • 2 years
2.0%
3/149 • Number of events 4 • 2 years
50.0%
1/2 • Number of events 1 • 2 years
20.0%
1/5 • Number of events 2 • 2 years
3.4%
5/146 • Number of events 6 • 2 years
Metabolism and nutrition disorders
deconditioning
4.1%
7/171 • Number of events 11 • 2 years
1.3%
2/149 • Number of events 2 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
4.8%
7/146 • Number of events 9 • 2 years
Injury, poisoning and procedural complications
Surgery
2.9%
5/171 • Number of events 8 • 2 years
2.0%
3/149 • Number of events 3 • 2 years
0.00%
0/2 • 2 years
20.0%
1/5 • Number of events 1 • 2 years
3.4%
5/146 • Number of events 6 • 2 years
Endocrine disorders
hypothyroidism
5.3%
9/171 • Number of events 10 • 2 years
6.7%
10/149 • Number of events 11 • 2 years
0.00%
0/2 • 2 years
0.00%
0/5 • 2 years
0.68%
1/146 • Number of events 1 • 2 years

Additional Information

Dr.Veronika Bachanova

Masonic Cancer Center, University of Minnesota

Phone: 612-625-5469

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place