Trial Outcomes & Findings for Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases (NCT NCT02145039)

NCT ID: NCT02145039

Last Updated: 2019-12-26

Results Overview

Percentage of patients that survive 2 years post-transplant

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

2 years

Results posted on

2019-12-26

Participant Flow

Participant milestones

Participant milestones
Measure	Haploidentical Stem Cell Transplant This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy (centigray) on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduced Intensity Conditioning and Haploidentical Related Bone Marrow for Patients With Hematologic Diseases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	67 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 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	2 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	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Percentage of patients that survive 2 years post-transplant

Outcome measures

Outcome measures
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
2 Year Survival	0 Participants

SECONDARY outcome

Timeframe: 42 days

Engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10\^8/L for 3 consecutive measurements.

Outcome measures

Outcome measures
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Number of Patients With Hematopoietic Engraftment	2 Participants

SECONDARY outcome

Timeframe: 100 days

Population: Chimerism at 6 months and 1 year not evaluated

Number of patients with chimerism at day 100, 6 months and 1 year

Outcome measures

Outcome measures
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Number of Patients With Chimerism Chimerism at day 100	2 Participants
Number of Patients With Chimerism Chimerism at 6 months	NA Participants Data not available due to patient's death
Number of Patients With Chimerism Chimerism at 1 year	NA Participants Data not available due to patient's death

SECONDARY outcome

Timeframe: 100 days

Outcome measures

Outcome measures
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Number of Patients Experiencing Acute Graft-versus-host Disease by 100 Days	1 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Data were not collected for this Outcome Measure as both participants died by the 6 month time point

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Haploidentical Stem Cell Transplant n=2 Participants This is a treatment guideline for HLA-Haploidentical hematopoietic stem cell transplant (HSCT) using a reduced intensity conditioning (RIC) regimen. This regimen consists of fludarabine, cyclophosphamide and low dose total body irradiation (TBI). Fludarabine: Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant. Cyclophosphamide: Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant. Total Body Irradiation: TBI 200cGy on day -1 before transplant. Haploidentical stem cell transplant: Non-T-cell depleted bone marrow infusion
Number of Patients Experiencing Transplant Related Mortality (TRM)	1 Participants

Adverse Events

Haploidentical Stem Cell Transplant

Serious events: 0 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Claudio Brunstein

University of Minnesota Cancer Center

Phone: 612-625-8942

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place