Trial Outcomes & Findings for Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes (NCT NCT00045305)
NCT ID: NCT00045305
Last Updated: 2023-06-28
Results Overview
Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation \[absolute values must last at least 2 months\] Hemoglobin \>11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.
Results posted on
2023-06-28
Participant Flow
This trial was open to accrual on May 18, 2005 with the first patient accrued on October 24, 2006. By September 23, 2009, 17 patients were enrolled to the trial and the first 15 patients were included in the interim analysis. This trial did not meet pre-defined criteria to continue to the second stage. In the end, a total of 17 patients were enrolled to the trial from 7 participating institutions.
Participant milestones
| Measure |
Arm I
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
Eligible and Treated
|
17
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Arm I
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
|
|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
3
|
|
Overall Study
site error
|
2
|
Baseline Characteristics
Reduced-Intensity Regimen Before Donor Bone Marrow Transplant in Treating Patients With Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
|
|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.Population: eligible and treated patients
Completed response is defined as: Bone marrow evaluation: Repeat bone marrow showing \< 5% myeloblasts with normal maturation of all cell lines, with no evidence for dysplasia (see dysplasia qualifier under peripheral blood evaluation). Peripheral blood evaluation \[absolute values must last at least 2 months\] Hemoglobin \>11 g/dl (untransfused, not on erythropoietin) Neutrophils (1500/mm3 (not on a myeloid growth factor)) Platelets (100,000/mm3 (not on a thrombopoetic agent)) Blasts - 0% No dysplasia. No detectable cytogenetic abnormality, if preexisting abnormality was present
Outcome measures
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Complete Response Rate
|
35.3 percentage of participants
Interval 16.6 to 58.0
|
SECONDARY outcome
Timeframe: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.Population: eligible and treated patients who achieved complete response
Disease free survival (DFS) was listed as a secondary endpoint in the study protocol, which would be assessed in patients who achieved complete response (CR). It was defined to be time from CR to documented progression or to death without progression. Patients without documented progression or death reported were censored at the time of last disease evaluation. However, due to the small number of patients with CR, the number of patients who developed disease progression was reported here.
Outcome measures
| Measure |
Arm I
n=6 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Number of Patients Who Developed Disease Progression After Achieving Complete Response
|
1 participants
|
SECONDARY outcome
Timeframe: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.Population: eligible and treated patients
Overall survival (OS) is defined to be the time from registration to death from any cause, with follow-up censored at the date of last contact. Kaplan-Meier method was used to estimate the distribution of OS.
Outcome measures
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Overall Survival
|
1.2 years
Interval 0.5 to
The upper bound of the 95% confidence interval has not reached yet for the median OS measure
|
SECONDARY outcome
Timeframe: Monthly for the first 3 months from study entry, every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5.Population: eligible and treated patients
Proportion of Graft versus Host Disease is calculated as number of patients with Graft versus Host Disease divided by all eligible and treated patients
Outcome measures
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Proportion of Graft Versus Host Disease
|
0.412 proportion of participants
Interval 0.184 to 0.671
|
SECONDARY outcome
Timeframe: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.Population: eligible and treated patients
Time to neutrophil engraftment is defined from date of infusion to date of neutrophil engraftment. Neutrophil engraftment is defined as ANC \> 500/mm3 on two consecutive measurements. The date of engraftment is the date of the first ANC \> 500/mm3.
Outcome measures
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Time to Engraftment for Neutrophil
|
18 days
Interval 14.0 to 21.0
|
SECONDARY outcome
Timeframe: Daily while hospitalized and then at least 1x/week for the first 50 days and then at least every other week until day 100.Population: eligible and treated patients
Time to platelet engraftment is defined from date of infusion to date of platelet engraftment. The platelet engraftment is defined as platelets \> 20,000 on two consecutive measurements, at least seven days apart, without platelet transfusions in between and for at least three days before the first measurement that is over 20,000. The date of engraftment is the date of the first measurement that is over 20,000.
Outcome measures
| Measure |
Arm I
n=17 Participants
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
Cyclosporine: Immunosuppressant
Methotrexate: Antimetabolite
|
|---|---|
|
Time to Engraftment for Platelet
|
18 days
Interval 16.0 to 30.0
|
Adverse Events
Arm I
Serious events: 17 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm I
n=17 participants at risk
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
82.4%
14/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Iron overload
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
White blood cell decreased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Neutrophil count decreased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Platelet count decreased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Heart failure
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Fatigue
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Anorexia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Dehydration
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Diarrhea
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Nausea
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Vascular disorders - Other, specify
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Hepatobiliary disorders
Hepatic failure
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Enterocolitis infectious
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
35.3%
6/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Infections and infestations - Other, spe
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Bladder infection
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Upper respiratory infection
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Edema limbs
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Alkaline phosphatase increased
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Alanine aminotransferase increased
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Aspartate aminotransferase increased
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Blood bilirubin increased
|
35.3%
6/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Creatinine increased
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Eye disorders
Eye disorders - Other, specify
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Abdominal pain
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Renal and urinary disorders
Acute kidney injury
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
Other adverse events
| Measure |
Arm I
n=17 participants at risk
Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.
Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.
Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.
|
|---|---|
|
Ear and labyrinth disorders
External ear inflammation
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
White blood cell decreased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Neutrophil count decreased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Platelet count decreased
|
94.1%
16/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Electrocardiogram QT corrected interval
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Sinus bradycardia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Sinus tachycardia
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Acute coronary syndrome
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Hypertension
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Hypotension
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Cardiac disorders
Pericardial effusion
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Fatigue
|
82.4%
14/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Fever
|
29.4%
5/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Psychiatric disorders
Insomnia
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Chills
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Weight loss
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Injection site reaction
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
70.6%
12/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Endocrine disorders
Cushingoid
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Hot flashes
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Anorexia
|
41.2%
7/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Colitis
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Constipation
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Diarrhea
|
76.5%
13/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Dysphagia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Esophagitis
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Hemorrhoids
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Mucositis oral
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Nausea
|
88.2%
15/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Dysgeusia
|
23.5%
4/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Vomiting
|
64.7%
11/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Renal and urinary disorders
Hematuria
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Skin and subcutaneous tissue disorders
Purpura
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Enterocolitis infectious
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Infections and infestations - Other, spe
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Edema limbs
|
70.6%
12/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
Edema trunk
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Alkaline phosphatase increased
|
76.5%
13/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Alanine aminotransferase increased
|
70.6%
12/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Aspartate aminotransferase increased
|
76.5%
13/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Blood bilirubin increased
|
100.0%
17/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Investigations
Creatinine increased
|
94.1%
16/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Injury, poisoning and procedural complications
Fracture
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
11.8%
2/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Psychiatric disorders
Confusion
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Dizziness
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Psychiatric disorders
Anxiety
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Psychiatric disorders
Depression
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
17.6%
3/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Tremor
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Eye disorders
Dry eye
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Eye disorders
Conjunctivitis
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Eye disorders
Blurred vision
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Gastrointestinal disorders
Abdominal pain
|
35.3%
6/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Headache
|
35.3%
6/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Nervous system disorders
Sinus pain
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Reproductive system and breast disorders
Vaginal pain
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
41.2%
7/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal di
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Renal and urinary disorders
Urinary frequency
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
General disorders
General disorders and administration sit
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
|
Vascular disorders
Thromboembolic event
|
5.9%
1/17 • Assessed at 30 days, 50 days, 100 days and 1 year post transplant
Any severe (Grade ≥ 3) long term toxicity that the patient has experienced prior to diagnosis of progression/relapse that has not been previously reported would be collected via long-term follow up form at the following schedule: every 3 months for the first two years from study entry thereafter and then every 6 months for years 3-5
|
Additional Information
Study Statistician
ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60