Trial Outcomes & Findings for Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant (NCT NCT00096161)
NCT ID: NCT00096161
Last Updated: 2020-01-31
Results Overview
A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
From the time of enrollment maintained to day 56 after the last DLI, up to Day 112
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
10
|
6
|
0
|
|
Overall Study
COMPLETED
|
20
|
10
|
6
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pentostatin and Lymphocyte Infusion in Preventing Graft Rejection in Patients Who Have Undergone Donor Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Age, Continuous
|
55 years
n=93 Participants
|
59.3 years
n=4 Participants
|
60.3 years
n=27 Participants
|
—
|
56.9 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
—
|
5 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
—
|
31 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=93 Participants
|
10 participants
n=4 Participants
|
6 participants
n=27 Participants
|
—
|
36 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: From the time of enrollment maintained to day 56 after the last DLI, up to Day 112Population: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
A regimen will be considered successful if 20 patients are enrolled, at least 13 demonstrate improved chimerism. If fewer than 5 patients have shown improvement in chimerism then it can be at least 75% confident that the true rate of improvement is less than 0.53. Enrollment to the regimen will stop and the next regimen will be opened. Enrollment to a regimen may also be stopped at any time it becomes impossible to achieve 5 of 10 or 13 of 20 successful improvements. "Chimerism" in hematopoietic cell transplant derives from this idea of a "mixed" entity, referring to someone who has received a transplant of genetically different tissue. A test for chimerism after a hematopoietic cell transplant involves identifying the genetic profiles of the recipient and of the donor and then evaluating the extent of mixture in the recipient's blood cells or marrow cells.
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Percentage Patients With an Increase of at Least 10 Percentage Points in Donor T-cell Chimerism
|
60 percentage of participants
|
30 percentage of participants
|
33.3 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: Within 100 days after the last DLIPopulation: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Clinical Stage of acute GVHD according to Organ System Skin: 1. \- Maculopapular rash \<25% of body surface 2. \- Maculopapular rash 25-50% of body surface 3. \- Maculopapular rash \>50% body surface area or generalized erythroderma 4. \- Generalized erythroderma with bullous formation and desquamation Liver: 1. \- Bilirubin 2-3 mg/dl 2. \- Bilirubin 3.1-6 mg/dl 3. \- Bilirubin 6.1-15 mg/dl 4. \- Bilirubin \>15 mg/dl Gut: 1. \- \>500-1000 mL diarrhea per day or (nausea, anorexia or vomiting with biopsy (EGD) confirmation of upper GI GVHD 2. \- \>1000 -1500 mL diarrhea per day 3. \- \>1500 mL diarrhea per day 4. \- \>1500 mL diarrhea per day plus severe abdominal pain with or without ileus Overall Clinical Grading of Severity of acute GVHD Grade IV: 0-4 Skin, 2-4 Liver, and/or 2-4 GI
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Incidence of Grade IV Acute GVHD
|
5 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year after DLIPopulation: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Percentage patients with acute or chronic GVHD. The diagnosis of chronic GVHD requires at least one manifestation that is distinctive for chronic GVHD as opposed to acute GVHD. In all cases, infection and others causes must be ruled out in the differential diagnosis of chronic GVHD.
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Incidence of GVHD
cGVHD
|
50 percentage of participants
|
20 percentage of participants
|
16.7 percentage of participants
|
—
|
|
Incidence of GVHD
aGVHD
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 100 days after DLIPopulation: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Incidence of Infections
|
80 percentage of participants
|
70 percentage of participants
|
33.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year after DLIPopulation: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
CML Acquisition of a new cytogenetic abnormality and/or development of accelerated phase or blast crisis. Criteria for accelerated phase: unexplained fever \>38.3° C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, BM blasts and promyelocytes \>20%. AML, ALL, CMML \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL Progressive disease: ≥1 of: physical exam/imaging studies (nodes, liver, and/or spleen) ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ tx; or definite increase in the size/number of plasmacytomas or lytic bone lesions.
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Incidence of Relapse/Progression
|
45 percentage of participants
|
20 percentage of participants
|
33.3 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 1 year after DLIPopulation: No subjects were enrolled onto Group 2D because the dose escalation was not triggered before the study closed to accrual.
Percentage patients surviving.
Outcome measures
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 Participants
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 Participants
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Survival
|
60 percentage of participants
|
90 percentage of participants
|
66.7 percentage of participants
|
—
|
Adverse Events
Group 1A (Pentostatin, DLI Dose Level 1)
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 1B (Pentostatin, DLI Dose Level 2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 participants at risk
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 participants at risk
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 participants at risk
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Immune system disorders
GVHD
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Blood and lymphatic system disorders
Hemolytic uremic syndrome
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
Other adverse events
| Measure |
Group 1A (Pentostatin, DLI Dose Level 1)
n=20 participants at risk
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (1x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 1B (Pentostatin, DLI Dose Level 2)
n=10 participants at risk
Patients receive pentostatin IV over 20-30 minutes on day -2 and DLI (3x10\^7 CD3+ cells/kg) over 15-30 minutes on day 0. Treatment may repeat once beginning with an escalated or same CD3-dose at least 4 weeks if persistent donor T-cells are documented, no GvHD has developed, and the chimerism status worsens or, if chimerism status is unchanged after at least 8 weeks with two subsequent tests of chimerism 4 weeks apart.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2C (Pentostatin, DLI Dose Level 1, Add'l IS)
n=6 participants at risk
Patients receive treatment as in group 1A. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
Group 2D (Pentostatin, DLI Dose Level 2, Add'l IS)
Patients receive treatment as in group 1B. Patients also receive cyclosporine PO BID on days -3 to 56 and mycophenolate mofetil PO QD on days 0 to 27. Treatment continues in the absence of GvHD.
Pentostatin: Given IV
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Investigations
Blood bilirubin increased
|
10.0%
2/20 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
16.7%
1/6 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Cardiac disorders
Cardiac troponin I increased
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Investigations
Creatinine increased
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Investigations
Forced expiratory volume decreased
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
10.0%
2/20 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Blood and lymphatic system disorders
Hemolysis
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
16.7%
1/6 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Vascular disorders
Hypotension
|
10.0%
2/20 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
15.0%
3/20 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
10.0%
1/10 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Gastrointestinal disorders
Ileal obstruction
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Investigations
Investigations - Other, (Pancytopenia)
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Infections and infestations
Small intestine infection
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
5.0%
1/20 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/10 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
|
General disorders
Fever
|
0.00%
0/20 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
10.0%
1/10 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
0.00%
0/6 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
—
0/0 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
One incident of GVHD was incorrectly reported as an SAE, as it is an expected complication of DLI. This patient outcome is recorded under deaths.
|
Additional Information
Dr. Brenda M. 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