Trial Outcomes & Findings for Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies (NCT NCT00536978)
NCT ID: NCT00536978
Last Updated: 2020-09-24
Results Overview
Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
6 Months
Results posted on
2020-09-24
Participant Flow
Recruitment Period: September 26, 2007 to April 24, 2009. All recruitment done at UT MD Anderson Cancer Center.
Of the 22 patients enrolled in the study, none were eligible to receive the adback T-Cell or Natural Killer (NK) cells.
Participant milestones
| Measure |
NK Cell/T-Cell Infusion
Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-C 100 mg/m\^2 IV Daily for 4 days and Melphalan 100 mg/m\^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks\]; or Non-myeloablative Preparative Regimen \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
22
|
Reasons for withdrawal
| Measure |
NK Cell/T-Cell Infusion
Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-C 100 mg/m\^2 IV Daily for 4 days and Melphalan 100 mg/m\^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks\]; or Non-myeloablative Preparative Regimen \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].
|
|---|---|
|
Overall Study
Not eligible for Adback Infusion
|
22
|
Baseline Characteristics
Natural Killer (NK) Cell Adback After Allogeneic Stem Cell Transplant With Campath-IH Plus Chemorx for Patients With Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
NK Cell/T-Cell Infusion
n=22 Participants
Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-C 100 mg/m\^2 IV Daily for 4 days and Melphalan 100 mg/m\^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks\]; or Non-myeloablative Preparative Regimen \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].
|
|---|---|
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Age, Continuous
|
54 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: Of the 22 patients enrolled, none received the adback T-Cell or NK cells treatment.
Number of participant deaths in 6 months of T- cell or Natural killer (NK) cell adback treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 YearEfficacy (disease-free-survival) defined as number of participants still living, without disease progression following T- cell or Natural killer (NK) cell adback. One-year disease-free survival (DFS) time estimated using the Kaplan-Meier estimator. Patients who experience disease recurrence considered to be a treatment failure event.
Outcome measures
Outcome data not reported
Adverse Events
NK Cell/T-Cell Infusion
Serious events: 14 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NK Cell/T-Cell Infusion
n=22 participants at risk
Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m\^2 IV, Etoposide 100 mg/m\^2 IV, Ara-C 100 mg/m\^2 IV Daily for 4 days and Melphalan 100 mg/m\^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks\]; or Non-myeloablative Preparative Regimen \[Fludarabine 30 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m\^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m\^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m\^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)\].
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|---|---|
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Blood and lymphatic system disorders
Neutrophils (ANC/AGC)
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome (ARDS)
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Blood and lymphatic system disorders
Fever, Neutropenic
|
9.1%
2/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Blood and lymphatic system disorders
Hypomagnesemia
|
9.1%
2/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Skin and subcutaneous tissue disorders
Stomatitis
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Blood and lymphatic system disorders
Hypophosphatemia
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
General disorders
Mood Alteration
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Investigations
Pain, Chest Wall
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Infections and infestations
Graft versus host disease (GVHD), Chronic
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
|
Infections and infestations
Infection, Neutropenic (other)
|
4.5%
1/22 • Most frequent and most serious adverse events collected during participants' standard of care (1 year and 10 months), not investigational treatment related adverse events.
Adverse events were not collected under the study design treatment as no participants received the Adback Infusion (treatment).
|
Other adverse events
Adverse event data not reported
Additional Information
Issa F. Khouri, MD / Professor, Stem Cell Transplantation
UT MD Anderson Cancer Center
Phone: 713-745-0049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place