Trial Outcomes & Findings for Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer (NCT NCT00003270)
NCT ID: NCT00003270
Last Updated: 2019-12-13
Results Overview
Continuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
day +100 after Cord Blood Transplant
Results posted on
2019-12-13
Participant Flow
Participant milestones
| Measure |
Arm 1
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Arm 1
n=20 Participants
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
32.5 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
|
Disease
ALL
|
3 Participants
n=93 Participants
|
|
Disease
AML
|
5 Participants
n=93 Participants
|
|
Disease
Aplastic Anemia
|
1 Participants
n=93 Participants
|
|
Disease
CML
|
7 Participants
n=93 Participants
|
|
Disease
MDS/MPD
|
4 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: day +100 after Cord Blood TransplantContinuous complete remission (for patients in complete remission before treatment) or induced complete remission (for patients not in complete remission before treatment)
Outcome measures
| Measure |
Arm 1
n=20 Participants
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Overall Response Rate
CR/CCR
|
12 Participants
|
|
Overall Response Rate
Progressed
|
1 Participants
|
|
Overall Response Rate
Not evaluable (early death)
|
7 Participants
|
SECONDARY outcome
Timeframe: 1 yeartime to disease progression or death due to any cause
Outcome measures
| Measure |
Arm 1
n=20 Participants
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Progression-free Survival
|
50 % of participants
Interval 28.0 to 72.0
|
Adverse Events
Arm 1
Serious events: 5 serious events
Other events: 5 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Arm 1
n=20 participants at risk
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Blood and lymphatic system disorders
DBE/FTE
|
25.0%
5/20 • Number of events 5 • Adverse Event, Serious Adverse Event and All Cause Mortality are from start of treatment (Day -7 or -5) through day +100 after cord blood infusion
SAE is delayed engraftment or failed to engraft Died before engraftment is defined as death before Absolute Neutrophil Count recovery Failure to engraft is defined as survival until at least day +42 without Absolute Neutrophil Count recovery Other AEs include acute GVHD grade III-IV and RRT grade 3-4 RRT is defined using Bearman Regimen Related Toxicity Criteria Acute GVHD grade III-IV is defined using Glucksberg criteria
|
Other adverse events
| Measure |
Arm 1
n=20 participants at risk
Eligible patients are treated with busulfan IV over 2 hours on days -7 to -4, cyclophosphamide IV over 2 hours on days -3 and -2, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1 (BuCyATG) and cord blood is infused on day 0; or are treated with cyclophosphamide IV over 2 hours on days -5 and -4, antithymocyte globulin (ATG) IV over 10 hours on days -3 to -1, and undergo TBI twice a day on days -3 to -1 (CyATGTBI) and cord blood is infused on day 0
|
|---|---|
|
Immune system disorders
Severe Acute graft-versus-host disease
|
25.0%
5/20 • Number of events 5 • Adverse Event, Serious Adverse Event and All Cause Mortality are from start of treatment (Day -7 or -5) through day +100 after cord blood infusion
SAE is delayed engraftment or failed to engraft Died before engraftment is defined as death before Absolute Neutrophil Count recovery Failure to engraft is defined as survival until at least day +42 without Absolute Neutrophil Count recovery Other AEs include acute GVHD grade III-IV and RRT grade 3-4 RRT is defined using Bearman Regimen Related Toxicity Criteria Acute GVHD grade III-IV is defined using Glucksberg criteria
|
Additional Information
Dr. Theresa Hahn
Roswell Park Comprehensive Cancer Center
Phone: 716-845-5819
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place