Trial Outcomes & Findings for The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients (NCT NCT02648932)
NCT ID: NCT02648932
Last Updated: 2021-03-18
Results Overview
Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Through one year after formal search
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
Haplo-Cord Search
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
Haplo-Cord Search
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Overall Study
No transplant
|
3
|
1
|
Baseline Characteristics
The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Baseline characteristics by cohort
| Measure |
Haplo-Cord Search
n=5 Participants
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
n=4 Participants
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 years
n=5 Participants
|
61.2 years
n=7 Participants
|
62.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through one year after formal searchPopulation: We analyze only those who went to transplant.
Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.
Outcome measures
| Measure |
Haplo-Cord Search
n=2 Participants
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
n=3 Participants
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Time to Transplant
|
69 days
Interval 63.0 to 74.0
|
111 days
Interval 68.0 to 149.0
|
SECONDARY outcome
Timeframe: Through one year after formal searchCompare percentage of patients who undergo HCT in each study cohort
Outcome measures
| Measure |
Haplo-Cord Search
n=5 Participants
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
n=4 Participants
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From date of randomization up to 3 yearsPopulation: We analyzed only those who went transplant.
Overall survival time was estimated from date of randomization and from date of transplant using Kaplan-Meier method.
Outcome measures
| Measure |
Haplo-Cord Search
n=2 Participants
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
n=3 Participants
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Estimated Survival Time
Days from randomization
|
162 days
Interval 162.0 to
There are not enough people have died yet to estimate the upper confidence interval. One of two participants survived.
|
785 days
Interval 607.0 to
There are not enough people have died yet to estimate the upper confidence interval. One of three participants survived.
|
|
Estimated Survival Time
Days from transplant
|
92 days
Interval 92.0 to
There are not enough people have died yet to estimate the upper confidence interval. One of two participants survived.
|
673 days
Interval 467.0 to
There are not enough people have died yet to estimate the upper confidence interval. One of three participants survived.
|
Adverse Events
Haplo-Cord Search
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Matched Unrelated Donor Search (MUD)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Haplo-Cord Search
n=2 participants at risk
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Haplo-Cord Transplant: For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
|
Matched Unrelated Donor Search (MUD)
n=3 participants at risk
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Matched Unrelated Donor Transplant
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • 100 days
|
66.7%
2/3 • 100 days
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
1/2 • 100 days
|
66.7%
2/3 • 100 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
50.0%
1/2 • 100 days
|
0.00%
0/3 • 100 days
|
|
General disorders
Fatigue
|
50.0%
1/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Skin and subcutaneous tissue disorders
Purpura
|
50.0%
1/2 • 100 days
|
0.00%
0/3 • 100 days
|
|
Investigations
Weight loss
|
50.0%
1/2 • 100 days
|
0.00%
0/3 • 100 days
|
|
Investigations
White blood cell decreased
|
50.0%
1/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • 100 days
|
66.7%
2/3 • 100 days
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
General disorders
Chills
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
General disorders
Fever
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Oral hemorrhage
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • 100 days
|
33.3%
1/3 • 100 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • 100 days
|
66.7%
2/3 • 100 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place