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Trial Outcomes & Findings for Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT (NCT NCT02988466)

NCT ID: NCT02988466

Last Updated: 2025-05-28

Results Overview

Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

1 year

Results posted on

2025-05-28

Participant Flow

Participant milestones

Participant milestones
Measure
Arm A: Haplo-HCT <55 Years Old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Overall Study
STARTED
14
21
8
35
Overall Study
COMPLETED
9
10
2
21
Overall Study
NOT COMPLETED
5
11
6
14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reduced Intensity (RIC) Conditioning And Transplantation of HLA-Haplo-HCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Total
n=78 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=99 Participants
15 Participants
n=107 Participants
8 Participants
n=206 Participants
11 Participants
n=7 Participants
48 Participants
n=31 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
6 Participants
n=107 Participants
0 Participants
n=206 Participants
24 Participants
n=7 Participants
30 Participants
n=31 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
8 Participants
n=107 Participants
5 Participants
n=206 Participants
12 Participants
n=7 Participants
31 Participants
n=31 Participants
Sex: Female, Male
Male
8 Participants
n=99 Participants
13 Participants
n=107 Participants
3 Participants
n=206 Participants
23 Participants
n=7 Participants
47 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
2 Participants
n=7 Participants
3 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=99 Participants
18 Participants
n=107 Participants
8 Participants
n=206 Participants
32 Participants
n=7 Participants
72 Participants
n=31 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
2 Participants
n=107 Participants
0 Participants
n=206 Participants
1 Participants
n=7 Participants
3 Participants
n=31 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
2 Participants
n=31 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
0 Participants
n=7 Participants
3 Participants
n=31 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
0 Participants
n=31 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=99 Participants
2 Participants
n=107 Participants
1 Participants
n=206 Participants
1 Participants
n=7 Participants
5 Participants
n=31 Participants
Race (NIH/OMB)
White
10 Participants
n=99 Participants
16 Participants
n=107 Participants
5 Participants
n=206 Participants
31 Participants
n=7 Participants
62 Participants
n=31 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
0 Participants
n=7 Participants
1 Participants
n=31 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=99 Participants
1 Participants
n=107 Participants
0 Participants
n=206 Participants
3 Participants
n=7 Participants
5 Participants
n=31 Participants
Region of Enrollment
United States
14 participants
n=99 Participants
21 participants
n=107 Participants
8 participants
n=206 Participants
35 participants
n=7 Participants
78 participants
n=31 Participants

PRIMARY outcome

Timeframe: 1 year

Percentage of participants that were disease-free survival (DFS) at 1 year post-transplant

Outcome measures

Outcome measures
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Disease-free Survival (DFS)
57 percentage of participants
Interval 28.0 to 78.0
29 percentage of participants
Interval 12.0 to 48.0
38 percentage of participants
Interval 9.0 to 67.0
57 percentage of participants
Interval 39.0 to 72.0

SECONDARY outcome

Timeframe: day 100

Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).

Outcome measures

Outcome measures
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
grade II-IV acute graft versus-host-disease (GVHD)
21 Percentage of participants
Interval 1.0 to 42.0
33 Percentage of participants
Interval 13.0 to 54.0
13 Percentage of participants
Interval 0.0 to 34.0
31 Percentage of participants
Interval 16.0 to 47.0
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
grade III-IV acute graft versus-host-disease (GVHD)
0 Percentage of participants
Interval 0.0 to 100.0
19 Percentage of participants
Interval 3.0 to 36.0
0 Percentage of participants
Interval 0.0 to 100.0
11 Percentage of participants
Interval 1.0 to 22.0

SECONDARY outcome

Timeframe: 6 month, 1 and 2 year

Percentage of participants experiencing treatment related mortality (TRM).

Outcome measures

Outcome measures
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Treatment Related Mortality (TRM)
TRM 2 years
21 Percentage of participants
Interval 1.0 to 42.0
58 Percentage of participants
Interval 36.0 to 81.0
13 Percentage of participants
Interval 0.0 to 34.0
27 Percentage of participants
Interval 12.0 to 42.0
Treatment Related Mortality (TRM)
TRM 6 months
21 Percentage of participants
Interval 1.0 to 42.0
57 Percentage of participants
Interval 39.0 to 75.0
13 Percentage of participants
Interval 0.0 to 34.0
26 Percentage of participants
Interval 13.0 to 38.0
Treatment Related Mortality (TRM)
TRM 1 year
21 Percentage of participants
Interval 1.0 to 42.0
57 Percentage of participants
Interval 35.0 to 79.0
13 Percentage of participants
Interval 0.0 to 34.0
26 Percentage of participants
Interval 11.0 to 40.0

SECONDARY outcome

Timeframe: 1 and 2 year

Percentage of participants experiencing a relapse incidence at 1 and 2 years.

Outcome measures

Outcome measures
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Relapse Incidence
Relapse Incidence 1 year
29 Percentage of participants
Interval 5.0 to 52.0
29 Percentage of participants
Interval 11.0 to 46.0
75 Percentage of participants
Interval 43.0 to 100.0
26 Percentage of participants
Interval 11.0 to 40.0
Relapse Incidence
Relapse Incidence 2 year
29 Percentage of participants
Interval 5.0 to 52.0
30 Percentage of participants
Interval 11.0 to 49.0
75 Percentage of participants
Interval 39.0 to 100.0
28 Percentage of participants
Interval 12.0 to 43.0

SECONDARY outcome

Timeframe: at day 100 and 1 year

Percentage of participants experiencing incidence of serious fungal and viral infection post-HCT

Outcome measures

Outcome measures
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 Participants
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Incidence of Serious Fungal and Viral Infection
Day 100
7 Percentage of participants
Interval 0.0 to 20.0
10 Percentage of participants
Interval 0.0 to 22.0
38 Percentage of participants
Interval 6.0 to 60.0
6 Percentage of participants
Interval 0.0 to 13.0
Incidence of Serious Fungal and Viral Infection
1 year
14 Percentage of participants
Interval 0.0 to 32.0
10 Percentage of participants
Interval 0.0 to 22.0
38 Percentage of participants
Interval 6.0 to 69.0
11 Percentage of participants
Interval 1.0 to 22.0

Adverse Events

Arm A: Haplo-HCT <55 Years Old

Serious events: 6 serious events
Other events: 10 other events
Deaths: 6 deaths

CLOSED Arm B: Haplo-HCT ≥55 Years Old

Serious events: 9 serious events
Other events: 11 other events
Deaths: 13 deaths

Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo

Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths

Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3

Serious events: 11 serious events
Other events: 15 other events
Deaths: 18 deaths

Serious adverse events

Serious adverse events
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Infections and infestations
Serious bacterial Infection
42.9%
6/14 • Number of events 56 • 2 years
42.9%
9/21 • Number of events 133 • 2 years
50.0%
4/8 • Number of events 36 • 2 years
31.4%
11/35 • Number of events 109 • 2 years

Other adverse events

Other adverse events
Measure
Arm A: Haplo-HCT <55 Years Old
n=14 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
n=21 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
n=8 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
n=35 participants at risk
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
Infections and infestations
Fungal Infection
14.3%
2/14 • Number of events 17 • 2 years
9.5%
2/21 • Number of events 51 • 2 years
37.5%
3/8 • Number of events 22 • 2 years
11.4%
4/35 • Number of events 27 • 2 years
Infections and infestations
Viral Infection
64.3%
9/14 • Number of events 95 • 2 years
47.6%
10/21 • Number of events 152 • 2 years
75.0%
6/8 • Number of events 43 • 2 years
34.3%
12/35 • Number of events 67 • 2 years

Additional Information

Mark Juckett, MD

University of Minnesota, Masonic Cancer Center

Phone: (612) 626-5654

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place