Trial Outcomes & Findings for Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease (NCT NCT00385788)
NCT ID: NCT00385788
Last Updated: 2018-05-09
Results Overview
Transplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Transplant to 100 days post transplant
Results posted on
2018-05-09
Participant Flow
Recruitment Period: July 14, 2005 to June 26, 2015. All recruitment done at The University of Texas MD Anderson Cancer Center.
First cohort (n=12) was treated before addition of Gemcitabine in the preparative regimen.
Participant milestones
| Measure |
Fludarabine + Melphalan
Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Gemcitabine + Fludarabine + Melphalan
Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) injection under skin once daily and Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
40
|
|
Overall Study
COMPLETED
|
12
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease
Baseline characteristics by cohort
| Measure |
Fludarabine + Melphalan
n=12 Participants
Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Gemcitabine + Fludarabine + Melphalan
n=40 Participants
Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.5 years
n=5 Participants
|
31 years
n=7 Participants
|
30 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
40 participants
n=7 Participants
|
52 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Transplant to 100 days post transplantTransplant-related mortality defined as death from any cause in the first 100 days post-transplant in patients without active disease.
Outcome measures
| Measure |
Fludarabine + Melphalan
n=12 Participants
Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Gemcitabine + Fludarabine + Melphalan
n=40 Participants
Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
|---|---|---|
|
Transplant Related Mortality Rate
|
1 Participants
|
6 Participants
|
Adverse Events
Fludarabine + Melphalan
Serious events: 3 serious events
Other events: 12 other events
Deaths: 1 deaths
Gemcitabine + Fludarabine + Melphalan
Serious events: 5 serious events
Other events: 40 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Fludarabine + Melphalan
n=12 participants at risk
Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Gemcitabine + Fludarabine + Melphalan
n=40 participants at risk
Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Primary Graft Failure
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Infections and infestations
Systemic Inflammatory Response Syndrome
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure/Sepsis
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Infections and infestations
Multi-Organ Failure/Infection
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress due to Infusion Reaction
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Gastrointestinal disorders
Gastrointestional (GI) Bleed
|
8.3%
1/12 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Renal and urinary disorders
Acute Renal Failure
|
25.0%
3/12 • Number of events 3 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Nervous system disorders
Seizure/Encephalopathy
|
8.3%
1/12 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
16.7%
2/12 • Number of events 2 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Cardiac disorders
Cardiac Dysfunction
|
8.3%
1/12 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
Other adverse events
| Measure |
Fludarabine + Melphalan
n=12 participants at risk
Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
Gemcitabine + Fludarabine + Melphalan
n=40 participants at risk
Gemcitabine 800 mg/m\^2 intravenous (IV) over 30 minutes Day -7; Fludarabine 33 mg/m\^2 IV Day -5 to Day -2 (4 days); Melphalan 70 mg/m\^2 IV over 30 minutes Day -3 to Day -2 (2 days). Antithymocyte Globulin 2 mg/kg IV for 2 days before stem cell transplantation Day 0. Tacrolimus 0.03 mg/kg IV Day -2 over 24 hours following infusion; beginning Day +7 Filgrastim (G-CSF) subcutaneously once daily + Methotrexate 5 mg/m2 by vein on Days +1, +3, +6, and +11.
|
|---|---|---|
|
Metabolism and nutrition disorders
Bilirubin
|
75.0%
9/12 • Number of events 9 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
37.5%
15/40 • Number of events 15 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Metabolism and nutrition disorders
Transaminitis
|
66.7%
8/12 • Number of events 14 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
60.0%
24/40 • Number of events 40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
4/12 • Number of events 4 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
32.5%
13/40 • Number of events 13 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Gastrointestinal disorders
Nausea
|
91.7%
11/12 • Number of events 11 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
92.5%
37/40 • Number of events 37 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Gastrointestinal disorders
Mucositis
|
66.7%
8/12 • Number of events 8 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
47.5%
19/40 • Number of events 19 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Metabolism and nutrition disorders
Creatinine
|
33.3%
4/12 • Number of events 4 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
15.0%
6/40 • Number of events 6 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Skin and subcutaneous tissue disorders
Skin Rash
|
16.7%
2/12 • Number of events 2 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
27.5%
11/40 • Number of events 11 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
20.0%
8/40 • Number of events 8 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Cardiac disorders
Hypertension (HTN)
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
7.5%
3/40 • Number of events 3 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Cardiac disorders
Cardiac
|
41.7%
5/12 • Number of events 10 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
17.5%
7/40 • Number of events 7 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
25.0%
10/40 • Number of events 10 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Blood and lymphatic system disorders
Pulmonary
|
50.0%
6/12 • Number of events 9 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
25.0%
10/40 • Number of events 10 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Infections and infestations
Infection
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
100.0%
40/40 • Number of events 66 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
General disorders
Fever
|
25.0%
3/12 • Number of events 3 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
65.0%
26/40 • Number of events 31 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Infections and infestations
Neutropenic Fever
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
27.5%
11/40 • Number of events 11 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Injury, poisoning and procedural complications
Secondary Graft Failure
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Gastrointestinal disorders
Pneumatosis Coli
|
0.00%
0/12 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
2.5%
1/40 • Number of events 1 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Infections and infestations
BK Cystitis
|
16.7%
2/12 • Number of events 2 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
12.5%
5/40 • Number of events 5 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
General disorders
Fatigue
|
25.0%
3/12 • Number of events 3 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
|
Nervous system disorders
Neurologic Pain
|
50.0%
6/12 • Number of events 13 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
0.00%
0/40 • Adverse events collected through post transplant with routine standard of care follow-up for patients receiving allogeneic stem cell transplantation, up to 100 days post-op.
|
Additional Information
Clinical Research Operations Team, Office of VP Clinical Research
UT MD Anderson Cancer Center
Phone: 713-792-7734
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place