Trial Outcomes & Findings for Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer (NCT NCT00075478)
NCT ID: NCT00075478
Last Updated: 2017-05-15
Results Overview
Percentage of patients surviving as estimated by Kaplan-Meier.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
87 participants
Primary outcome timeframe
3 years after transplant
Results posted on
2017-05-15
Participant Flow
Participant milestones
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
45
|
|
Overall Study
COMPLETED
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Overall Study
not eligible
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
54.5 years
n=7 Participants
|
56 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
37 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 years after transplantPercentage of patients surviving as estimated by Kaplan-Meier.
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Overall Survival
|
65 percentage of participants
|
54 percentage of participants
|
SECONDARY outcome
Timeframe: 3 years after transplantPercentage of NRM as estimated by cumulative incidence methods with competing risks
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Non-relapse Mortality
|
7 percentage of participants
Interval 9.0 to 254.0
|
9 percentage of participants
Interval 98.0 to 287.0
|
SECONDARY outcome
Timeframe: 3 years after transplantPercentage of relapse estimated by cumulative incidence methods
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Relapse/Progression
|
40 percentage of participants
|
55 percentage of participants
|
SECONDARY outcome
Timeframe: 3 years after transplantPercentage of death following relapse/progression, estimated by cumulative incidence methods
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Relapse-related Mortality
|
28 percentage of participants
|
37 percentage of participants
|
SECONDARY outcome
Timeframe: 120 days after transplantPercentage patients with grades II-IV GHVD, estimated by cumulative incidence methods
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Grades II-IV Acute GVHD
|
46 percentage of participants
|
32 percentage of participants
|
SECONDARY outcome
Timeframe: 3 years after transplantPercentage patients with chronic extensive GVHD, estimated by cumulative incidence methods
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Chronic Extensive GVHD
|
72 percentage of participants
|
48 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year after transplantDonor CD3 chimerism less than 5%
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Incidence of Graft Rejection
|
0 participants
Interval 0.0 to 0.0
|
2 participants
Interval 31.0 to 31.0
|
SECONDARY outcome
Timeframe: 3 years after transplantPercentage of patients with progression-free survival, estimated by cumulative incidence methods
Outcome measures
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 Participants
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 Participants
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Progression-free Survival
|
53 percentage of participants
|
36 percentage of participants
|
Adverse Events
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
Serious events: 8 serious events
Other events: 34 other events
Deaths: 0 deaths
Arm II (TBI, Transplant, GVHD Prophylaxis)
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 participants at risk
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 participants at risk
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
4.9%
2/41
|
2.3%
1/44
|
|
Nervous system disorders
seizure
|
2.4%
1/41
|
0.00%
0/44
|
|
Cardiac disorders
pericardial effusion
|
2.4%
1/41
|
0.00%
0/44
|
|
Vascular disorders
thrombosis
|
4.9%
2/41
|
2.3%
1/44
|
|
Immune system disorders
Bactrim anaphylaxis
|
2.4%
1/41
|
0.00%
0/44
|
|
Immune system disorders
Graft versus host disease with infection and organ failure
|
0.00%
0/41
|
4.5%
2/44
|
|
Vascular disorders
subdural hematoma
|
0.00%
0/41
|
2.3%
1/44
|
|
Infections and infestations
sepsis
|
2.4%
1/41
|
0.00%
0/44
|
Other adverse events
| Measure |
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
n=41 participants at risk
Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
fludarabine phosphate: Given IV
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
Arm II (TBI, Transplant, GVHD Prophylaxis)
n=44 participants at risk
Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.
total-body irradiation: Undergo TBI
mycophenolate mofetil: Given PO
cyclosporine: Given PO
peripheral blood stem cell transplantation: Undergo transplantation
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone marrow
|
36.6%
15/41
|
22.7%
10/44
|
|
Cardiac disorders
Cardiovascular
|
9.8%
4/41
|
11.4%
5/44
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
0.00%
0/41
|
2.3%
1/44
|
|
Gastrointestinal disorders
Gastrointestinal
|
4.9%
2/41
|
6.8%
3/44
|
|
Vascular disorders
Hemorrhage
|
7.3%
3/41
|
2.3%
1/44
|
|
Hepatobiliary disorders
Hepatic
|
12.2%
5/41
|
6.8%
3/44
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
7.3%
3/41
|
2.3%
1/44
|
|
General disorders
Pain
|
2.4%
1/41
|
0.00%
0/44
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
9.8%
4/41
|
9.1%
4/44
|
|
Renal and urinary disorders
Renal/Genitourinary
|
9.8%
4/41
|
2.3%
1/44
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second Malignancy
|
2.4%
1/41
|
0.00%
0/44
|
Additional Information
Dr. Brenda Sandmaier
Fred Hutchinson Cancer Research Center/
Phone: 206-667-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place