Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia (NCT NCT00612716)
NCT ID: NCT00612716
Last Updated: 2020-12-09
Results Overview
Graft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
3 Months
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Allogeneic Transplantation
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With Previously Treated Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsGraft failure is defined as not accepting donated cells. The donated cells do not make the new white blood cells, red blood cells and platelets.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Engraftment Failure
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 42Time to 1st 3 consecutive days with absolute neutrophil count (ANC) \> 5 x 10\^8/L and percentage of patients with neutrophil recovery by day 42 (Cumulative incidence).
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Neutrophil Engraftment
|
5 Participants
|
PRIMARY outcome
Timeframe: Day 180Time to platelets \> 20,000 (first of 3 consecutive days) with no platelet transfusions for seven days and percentage of patients with platelet engraftment \>50,000 by day 100.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Platelet Engraftment
|
2 Participants
|
PRIMARY outcome
Timeframe: Day 100Acute Graft-Versus-Host Disease is a severe short-term complication created by infusion of donor cells into a foreign host.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Grade 3-4 Acute Graft-versus-host Disease
|
3 Participants
|
PRIMARY outcome
Timeframe: 3 Yearsthe return of disease after its apparent recovery/cessation.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Persistence Disease
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 Yearsthe return of disease after its apparent recovery/cessation.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With Relapse of Malignancy
|
1 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With 1 Year Overall Survival
|
2 Participants
|
PRIMARY outcome
Timeframe: 2 yearThe percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. Also called survival rate. Overall survival will be defined as time from date enrollment to date of death or censored at the date of last documented contact for patients still alive.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With 2 Year Overall Survival
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 YearChronic Graft-Versus-Host Disease is a severe long-term complication created by infusion of donor cells into a foreign host.
Outcome measures
| Measure |
Allogeneic Transplantation
n=6 Participants
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Number of Participants With of Chronic GVHD.
|
0 Participants
|
Adverse Events
Allogeneic Transplantation
Serious events: 3 serious events
Other events: 6 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Allogeneic Transplantation
n=6 participants at risk
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Injury, poisoning and procedural complications
Primary graft failure
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Death
|
50.0%
3/6 • Number of events 3 • 5 years
|
Other adverse events
| Measure |
Allogeneic Transplantation
n=6 participants at risk
Patients receiving total body irradiation, stem cell infusion (allogeneic)transplantation using unrelated or partially matched allogeneic marrow or cord blood donors, busulfan, and cyclophosphamide.
|
|---|---|
|
Metabolism and nutrition disorders
Failure to thrive
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Platelet refractory
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Abnormal bilirubin
|
50.0%
3/6 • Number of events 6 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Active Malignancy
|
83.3%
5/6 • Number of events 6 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndorme
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Reproductive system and breast disorders
Acute sinusitis
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac disorder, other
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Cyclosporine renal dysfunction
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Dialysis
|
50.0%
3/6 • Number of events 3 • 5 years
|
|
Blood and lymphatic system disorders
Disseminated Intravascular Coagulation
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Drug toxicity
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Duodenal capillary congestion
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Investigations
Elevated Partial Thromboplastin Time
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Embolization of uterine artery
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Nervous system disorders
Epileptic episode
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
GI bleeding
|
66.7%
4/6 • Number of events 5 • 5 years
|
|
Immune system disorders
Graft vs host disease
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Hemolysis
|
66.7%
4/6 • Number of events 5 • 5 years
|
|
Renal and urinary disorders
Hemolytic uremia
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
66.7%
4/6 • Number of events 4 • 5 years
|
|
Reproductive system and breast disorders
Hypogonadism
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Investigations
Hypokalemic
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Investigations
Hypomagnesmia
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Increased creatinine
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Infections and infestations
Infection
|
83.3%
5/6 • Number of events 80 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Intubation
|
66.7%
4/6 • Number of events 4 • 5 years
|
|
Nervous system disorders
Learning Dysfunction
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
muscle disorder other
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neurotoxicity
|
33.3%
2/6 • Number of events 2 • 5 years
|
|
Cardiac disorders
Pancytopenic
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Pneumonia
|
50.0%
3/6 • Number of events 5 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
66.7%
4/6 • Number of events 4 • 5 years
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Infections and infestations
Septicemia
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Subarachoid bleed
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Thrombosis
|
16.7%
1/6 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Uremic platelet dysfunction
|
16.7%
1/6 • Number of events 2 • 5 years
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Vascular disorder, other
|
16.7%
1/6 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Veno occulisive disease
|
16.7%
1/6 • Number of events 1 • 5 years
|
Additional Information
Dr. Daniel J.Weisdorf, M.D
Masonic Cancer Center, University of Minnesota
Phone: 612 624-3101
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place