Trial Outcomes & Findings for Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma (NCT NCT00238433)
NCT ID: NCT00238433
Last Updated: 2017-09-27
Results Overview
The data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
37 participants
Primary outcome timeframe
3, 6, 9, 12, 18, and 24 months post transplantation
Results posted on
2017-09-27
Participant Flow
Participant milestones
| Measure |
Busulfan/Melphalan/Thiotepa
Treatment:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) \> 1500 for 2 consecutive days.
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Busulfan/Melphalan/Thiotepa
Treatment:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg intravenous piggyback (IVPB) will be administered beginning on day +5 and continued until absolute neutrophil count (ANC) \> 1500 for 2 consecutive days.
|
|---|---|
|
Overall Study
Screen failure
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Busulfan, Melphalan, and Thiotepa in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Hodgkin's or Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Busulfan/Melphalan/Thiotepa
n=36 Participants
Treatment Plan:
Drug: Busulfan 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Drug: Melphalan 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Drug: Thiotepa 250 mg/m2/day/iv on days -3 and -2.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Administration Growth Factor: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days.
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3, 6, 9, 12, 18, and 24 months post transplantationThe data presented below represents the total number of subjects (out of 36) that reached disease-free survival status during Months 3, 6, 9, 12, 18, and 24 time points.
Outcome measures
| Measure |
Busulfan/Melphalan/Thiotepa
n=36 Participants
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days.
|
|---|---|
|
Disease-Free Survival
3 months
|
34 Participants
|
|
Disease-Free Survival
6 months
|
30 Participants
|
|
Disease-Free Survival
9 months
|
28 Participants
|
|
Disease-Free Survival
12 months
|
25 Participants
|
|
Disease-Free Survival
18 months
|
24 Participants
|
|
Disease-Free Survival
24 months
|
22 Participants
|
PRIMARY outcome
Timeframe: Through 24 months post transplantationThe table presented below reflects how many participants (out of 36 total) presented an adverse event related to the treatment regimen within each toxicity category. To review specific adverse events, both related and unrelated to study treatment, please refer to Adverse Events Section.
Outcome measures
| Measure |
Busulfan/Melphalan/Thiotepa
n=36 Participants
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim 5mcg/kg IVPB will be administered beginning on day +5 and continued until ANC\> 1500 for 2 consecutive days.
|
|---|---|
|
Therapy-Related Toxicities
Dermatological Toxicities
|
3 Participants
|
|
Therapy-Related Toxicities
Gastrointestinal Toxicities
|
26 Participants
|
|
Therapy-Related Toxicities
Immune System Toxicites
|
1 Participants
|
|
Therapy-Related Toxicities
Infections
|
33 Participants
|
|
Therapy-Related Toxicities
Metabolic Toxicities
|
3 Participants
|
|
Therapy-Related Toxicities
Respiratory Toxicities
|
2 Participants
|
|
Therapy-Related Toxicities
Vascular Toxicities
|
1 Participants
|
Adverse Events
BuMelTT
Serious events: 36 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BuMelTT
n=36 participants at risk
\*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
TREATMENT PLAN:
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.6%
2/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Cardiac disorders
Cardiac arrest
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Anorexia
|
13.9%
5/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Colonic obstruction
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Dehydration
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Ileum obstruction
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Mucositis
|
55.6%
20/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
8/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Febrile neutropenia
|
91.7%
33/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Influenza A
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Sepsis
|
5.6%
2/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Nervous system disorders
Vasovagal reaction
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Psychiatric disorders
Opioid overdose
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Psychiatric disorders
Suicide attempt
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
Other adverse events
| Measure |
BuMelTT
n=36 participants at risk
\*For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
TREATMENT PLAN:
Busulfan: 3.2mg/kg/day for 3 days starting on day -8. Each dose of intravenous busulfan will be mixed in a concentration of 0.54 mg/ml of 0.9% saline and infused over 3 hours.
Melphalan: 50mg/m2/day/iv, infused over 30 minutes on days -5 and -4. The reconstituted melphalan is diluted in 250cc normal saline to a concentration not greater than 0.4 mg/ml.
Thiotepa: 250 mg/m2/day/iv on days -3 and -2
Procedure/Surgery: bone marrow ablation with stem cell support
The transplant therapy should begin within 2 weeks of registration, but no sooner then 30 days after the last dose of chemotherapy.
Procedure/Surgery: Peripheral blood stem cell transplantation. Performed 36-48 hours following last chemotherapy dose.
Growth factor administration: Filgrastim
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Diarrhea
|
13.9%
5/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Distended abdomen
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Gastrointestinal disorders
Esophagitis
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
General disorders
Fatigue
|
5.6%
2/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Immune system disorders
Auto GVHD
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Clostridium difficile colitis (C. diff)
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Entercolitis
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Infections and infestations
Pancolitis
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Abnormal ALT (alanine aminotransferase ) lab result
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Abnormal amylase lab result
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
11.1%
4/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
25.0%
9/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.9%
5/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
38.9%
14/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness (lower limb)
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Psychiatric disorders
Eating disorder
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Renal and urinary disorders
Urinary retention
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis/early bronchopneumonia
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Skin and subcutaneous tissue disorders
General skin rash
|
2.8%
1/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
|
Skin and subcutaneous tissue disorders
Thiotepa-induced skin rash
|
8.3%
3/36 • For all adverse events grade 3 or higher is recorded for the first 100 days post transplant. After 100 days post transplant, all unexpected grade 3 and 4 adverse events will be recorded and reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place