Trial Outcomes & Findings for Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors (NCT NCT02519712)

NCT ID: NCT02519712

Last Updated: 2018-04-06

Results Overview

Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected. Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain \< 5% blasts. Auer rods should not be detected. Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.

Recruitment status

TERMINATED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

4 weeks

Results posted on

2018-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Donors and participants are combined because the study was closed to poor accrual and there are no clinical results.
Overall Study STARTED	4
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Donors and participants are combined because the study was closed to poor accrual and there are no clinical results.
Overall Study Disease Relapse	1
Overall Study Disease Progression	1
Overall Study Accruals are donors	2

Baseline Characteristics

Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells n=4 Participants This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Adverse Events information cannot be separated by donors and recipients due to data privacy reasons.
Age, Continuous	61 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Data were not collected

Outcome measures

Outcome data not reported

Adverse Events

Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells

Serious events: 2 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells n=4 participants at risk This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Adverse Events information cannot be separated by donors and recipients due to data privacy reasons
Gastrointestinal disorders Abdominal Pain	50.0% 2/4 • Discharge to 100 +/- 7 days
Investigations Platelet count decreased	50.0% 2/4 • Discharge to 100 +/- 7 days

Other adverse events

Other adverse events
Measure	Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells n=4 participants at risk This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML. Adverse Events information cannot be separated by donors and recipients due to data privacy reasons
Gastrointestinal disorders Abdominal Pain	25.0% 1/4 • Discharge to 100 +/- 7 days

Additional Information

Brian Shaffer, MD

Memorial Sloan Kettering Cancer Center

Phone: 212-639-2212

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place