TCR-α/β and CD19 Depleted Stem Cell Grafts From Haplo Donors for HSCT in Relapsed Lymphoma
Study Details
Study Description
Brief Summary
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell and CD19 cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for peripheral blood stem cell transplant in relapsed lymphoma.
Assess incidence of acute Graft Versus Host Disease (GVHD), chronic GVHD, graft failure rate, treatment related mortality rate, progression free survival and overall survival of patients.
The stem cell product will be processed using an investigational Miltenyi cell selection device/system that removes the alpha/beta T-cells and CD19+ cells, immune system cells that are more likely to cause GVHD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Peripheral Blood Stem Cell Transplant PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over approximately 30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants also undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg participant body weight (BW), patients may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the participant). |
Drug: Fludarabine Phosphate
Fludarabine will be administered by IV over approximately 30 minutes for 4 days.
Drug: Mesna
Given IV over 24 hours starting prior to cyclophosphamide
Drug: Cyclophosphamide
Given IV for 2 days
Radiation: Total nodal irradiation
Undergo total lymphoid irradiation
Biological: T Cell-Depleted Hematopoietic Stem Cell Transplantation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
Drug: Mycophenolate Mofetil
Given PO
Other Names:
Drug: Tacrolimus
Given PO or IV ONLY if graft cell content is over 1 x 10^5 cells/kg ideal BW of the patient
Biological: Rituximab
Given IV ONLY if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days [At day 28 after transplantation]
To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma.
Secondary Outcome Measures
- Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria [Day +100]
The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported.
- Number of Participants With Severe Chronic GVHD [Day +180]
The number of participants with severe chronic GVHD by Day +180 will be reported.
- Number of Participants With Graft Failure [Up to 2 years after graft]
Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved.
- Number of Participants With Treatment-related Mortality [Up to 2 years after graft]
Treatment-related mortality is defined as death from any cause other than disease progression.
- Progression-free Survival [Median follow up of 1689 days]
Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow,
- Overall Survival (OS) [Median follow up of 1689 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants must meet one of the following disease criteria within 24 months of registration. Salvage therapy is allowed between the participant meeting one of the below criterion and registration. Participant will be considered eligible regardless of their current disease status (i.e. complete remission, partial remission, stable disease, progressive disease) unless otherwise noted below as long as one of the below criterion has been met within the previous 24 months:
-
Relapsed/refractory Hodgkin lymphoma after autologous stem cell transplantation
-
Relapsed/refractory Hodgkin lymphoma, deemed ineligible for autologous stem cell transplantation due to refractory disease
-
Relapsed/refractory diffuse large B cell lymphoma after autologous stem cell transplantation (history of transformed lymphoma is acceptable). Disease must be in at least complete remission or partial remission with the use of salvage therapy before study treatment commences.
-
Relapsed/refractory diffuse large B cell lymphoma, deemed ineligible for autologous stem cell transplantation due to refractory disease (history of transformed lymphoma is acceptable). Disease must be in at least complete remission or partial remission with the use of salvage therapy before study treatment commences.
-
Relapsed/refractory T cell lymphoma relapsed after at least 1 prior line of therapy
-
Relapsed/refractory follicular lymphoma relapsed after at least 1 prior line of therapy
-
Relapsed/refractory mantle cell lymphoma relapsed after at least 1 prior line of therapy
-
Relapsed/refractory small lymphocytic lymphoma/chronic lymphocytic leukemia relapsed after at least 1 prior line of therapy
-
Relapsed/refractory non-Hodgkin Lymphoma, if not specified above, relapsed after at least 1 prior line of therapy
-
Karnofsky score of 60% or better ("Requires occasional assistance, but is able to care for most of his/her needs").
-
Pulmonary: Carbon Monoxide Diffusion Capacity (DLCO) (corrected for hemoglobin) > 40%; and Forced Expiratory Volume (FEV1) > 50%
-
Cardiac: ejection fraction (EF) ≥ 50%. No uncontrolled angina or active cardiac symptoms consistent with congestive heart failure (class III or IV), by the New York Heart Association criteria. No symptomatic ventricular arrhythmias or ECG evidence of active ischemia. No evidence by echocardiography of severe valvular stenosis or regurgitation.
-
Renal: estimated glomerular filtration rate (GFR) by Modification of Diet in Renal Disease (MDRD) formula > 40 mL/min/1.73m2
-
Women of child bearing potential must have a negative serum or urine pregnancy test within 14 days prior to study registration and agree to use adequate birth control during study treatment. A female of childbearing potential (FCBP) is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
-
Voluntary written consent
Exclusion Criteria:
-
Active Central nervous system (CNS) lymphoma within two weeks of registration. Patients with a history of CNS involvement must have adequate treatment as defined by at least two negative spinal fluid assessments separated by at least one week. (Otherwise Lumbar Puncture (LP) is not required if no clinical suspicion or evidence of CNS involvement.) Patients who have received cranial radiation therapy must still be eligible to receive total lymphoid irradiation to 7 Gy.
-
New or active infection as determined by fever, unexplained pulmonary infiltrate or sinusitis on radiographic assessment. Infections diagnosed within 4 weeks of registration must be determined to be controlled or resolving prior to treatment.
-
Presence of HIV, or active hepatitis A, B, or C infection
-
Allergy or hypersensitivity to agents used within the treatment protocol.
-
For an indolent lymphoma histology (follicular lymphoma, Small Lymphocytic Lymphoma/Chronic Lymphocytic Leukemia (SLL/CLL)) or mantle cell lymphoma, the patient should not have an HLA-matched sibling, who would be an eligible donor, available.
-
History of prior mediastinal radiation
-
Reported illicit drug use
-
Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- University of Wisconsin, Madison
Investigators
- Principal Investigator: Vaishalee P Kenkre, Principal Investigator
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- UW14113
- 2015-0996
- NCI-2015-02269
- A534260
- SMPH\MEDICINE\HEM-ONC
- Protocol Version 4/24/2020
Study Results
Participant Flow
| Recruitment Details | Patients of the University of Wisconsin Carbone Cancer Center were enrolled from March 2016 to June 2018. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo T-Cell Receptor (TCR) alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg participant body weight (BW), Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil orally twice a day (PO BID) on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Period Title: Overall Study | |
| STARTED | 11 |
| COMPLETED | 11 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Overall Participants | 11 |
| Age, Customized (Count of Participants) | |
| 20-29 years |
1
9.1%
|
| 30-39 years |
1
9.1%
|
| 40-49 years |
1
9.1%
|
| 50-59 years |
3
27.3%
|
| 60-69 years |
5
45.5%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
11
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
11
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
11
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
11
100%
|
Outcome Measures
| Title | Number of Participants With Absolute Neutrophil Count >= 500/Mcl for 3 Consecutive Measurements on Different Days and Platelet Count > 20,000/mm^3 With no Platelet Transfusions in the Preceding 7 Days |
|---|---|
| Description | To determine engraftment of neutrophils and platelets at 28 days following alpha/beta T-cell depletion using Human Leukocyte Antigen (HLA) haploidentical donors for stem cell transplant in relapsed lymphoma. |
| Time Frame | At day 28 after transplantation |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Count of Participants [Participants] |
11
100%
|
| Title | Number of Participants With Grade III-IV Acute GVHD as Determined by International Bone Marrow Transplant Registry (IBMTR) Severity Index Criteria |
|---|---|
| Description | The number of participants with grade III - IV acute Graft versus host disease (GVHD) by Day +100 is reported. |
| Time Frame | Day +100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Count of Participants [Participants] |
3
27.3%
|
| Title | Number of Participants With Severe Chronic GVHD |
|---|---|
| Description | The number of participants with severe chronic GVHD by Day +180 will be reported. |
| Time Frame | Day +180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Graft Failure |
|---|---|
| Description | Graft failure - defined as < 5% donor chimerism in the CD3 and/or CD33 selected cell populations at any time during the study follow up period once initial engraftment has been achieved. |
| Time Frame | Up to 2 years after graft |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Count of Participants [Participants] |
0
0%
|
| Title | Number of Participants With Treatment-related Mortality |
|---|---|
| Description | Treatment-related mortality is defined as death from any cause other than disease progression. |
| Time Frame | Up to 2 years after graft |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Count of Participants [Participants] |
4
36.4%
|
| Title | Progression-free Survival |
|---|---|
| Description | Progression-free survival will be analyzed as time before any progression by either Positron Emission Tomography/Computed Tomography (PET/CT) or bone marrow, |
| Time Frame | Median follow up of 1689 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Median (Full Range) [days] |
352
|
| Title | Overall Survival (OS) |
|---|---|
| Description | |
| Time Frame | Median follow up of 1689 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant |
|---|---|
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). |
| Measure Participants | 11 |
| Median (Full Range) [days] |
352
|
Adverse Events
| Time Frame | up to 5.5 years | |
|---|---|---|
| Adverse Event Reporting Description | Other Adverse Events data was collected through 1 year per protocol. The data safety monitoring committee requested an additional year of data collection for serious adverse events (ie, relapses, deaths, hospitalizations, etc), SAEs are reported to 2 years per an amendment approved on 6/5/2020. All-Cause Mortality data are reported for the entire study duration, up to 5.5 years. | |
| Arm/Group Title | Peripheral Blood Stem Cell Transplant | |
| Arm/Group Description | PREPARATIVE REGIMEN: Participants receive fludarabine phosphate IV over ~30 minutes on days -5 to -2, and mesna IV over 24 hours and cyclophosphamide IV over approximately 2 hours on days -5 and -4. Participants undergo total nodal irradiation on day -1. TRANSPLANT: Participants undergo TCR alpha-beta/CD19 depleted hematopoietic stem cell transplant on day 0. If the graft contains less than 4 x 10^6 CD34+ cells/kg patient BW, Participants may receive a second graft on day 1. GVHD PROPHYLAXIS: Participants receive mycophenolate mofetil PO BID on days -1 to 30, tacrolimus PO or IV on days 2-180 with a taper beginning on day 90 (given only if graft TCR alpha-beta+ cell content is over 1 x 10^5 cells/kg ideal BW of the patient), and rituximab IV on day 2 (given only if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient). | |
All Cause Mortality |
||
| Peripheral Blood Stem Cell Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/11 (54.5%) | |
Serious Adverse Events |
||
| Peripheral Blood Stem Cell Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | 10/11 (90.9%) | |
| Cardiac disorders | ||
| Cardiac Arrest | 2/11 (18.2%) | 2 |
| Pericardial effusion | 3/11 (27.3%) | 3 |
| Right ventricular dysfunction | 1/11 (9.1%) | 1 |
| Atrial Fibrillation | 1/11 (9.1%) | 1 |
| Atrial Flutter | 1/11 (9.1%) | 1 |
| Heart Failure | 3/11 (27.3%) | 4 |
| Gastrointestinal disorders | ||
| Diarrhea | 1/11 (9.1%) | 1 |
| Nausea | 1/11 (9.1%) | 1 |
| Vomiting | 1/11 (9.1%) | 1 |
| General disorders | ||
| Death NOS | 1/11 (9.1%) | 1 |
| Immune system disorders | ||
| Immune System Disorders - Other | 1/11 (9.1%) | 1 |
| Infections and infestations | ||
| Infections and infestations - Other, specify | 5/11 (45.5%) | 11 |
| Sepsis | 2/11 (18.2%) | 3 |
| Lung Infection | 3/11 (27.3%) | 4 |
| Investigations | ||
| Platelet count decreased | 1/11 (9.1%) | 1 |
| Blood Bilirubin Increased | 1/11 (9.1%) | 1 |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/11 (9.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | 1/11 (9.1%) | 2 |
| Renal and urinary disorders | ||
| Acute kidney injury | 3/11 (27.3%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||
| Respiratory failure | 1/11 (9.1%) | 1 |
| Dyspnea | 1/11 (9.1%) | 1 |
| Hypoxia | 3/11 (27.3%) | 4 |
| Pneumonitis | 2/11 (18.2%) | 3 |
| Thromboembolitic Event | 1/11 (9.1%) | 1 |
| Pulmonary Hypertension | 1/11 (9.1%) | 2 |
| Pleural Effusion | 1/11 (9.1%) | 1 |
| Vascular disorders | ||
| Hematoma | 1/11 (9.1%) | 2 |
| Hypotension | 1/11 (9.1%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Peripheral Blood Stem Cell Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | 11/11 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 11/11 (100%) | 59 |
| Blood and lymphatic system disorders - Other, specify | 2/11 (18.2%) | 10 |
| Febrile neutropenia | 2/11 (18.2%) | 4 |
| Hemolytic uremic syndrome | 2/11 (18.2%) | 2 |
| Cardiac disorders | ||
| Atrial fibrillation | 3/11 (27.3%) | 8 |
| Atrial flutter | 2/11 (18.2%) | 4 |
| Cardiac arrest | 1/11 (9.1%) | 1 |
| Chest pain - cardiac | 2/11 (18.2%) | 2 |
| Heart failure | 1/11 (9.1%) | 2 |
| Left ventricular systolic dysfunction | 1/11 (9.1%) | 1 |
| Palpitations | 1/11 (9.1%) | 1 |
| Paroxysmal atrial tachycardia | 1/11 (9.1%) | 1 |
| Pericardial effusion | 2/11 (18.2%) | 2 |
| Sinus tachycardia | 4/11 (36.4%) | 9 |
| Ventricular tachycardia | 1/11 (9.1%) | 2 |
| Endocrine disorders | ||
| Hypothyroidism | 1/11 (9.1%) | 1 |
| Eye disorders | ||
| Blurred vision | 1/11 (9.1%) | 5 |
| Eye disorders - Other, specify | 2/11 (18.2%) | 2 |
| Floaters | 1/11 (9.1%) | 1 |
| Gastrointestinal disorders | ||
| Abdominal pain | 5/11 (45.5%) | 12 |
| Bloating | 1/11 (9.1%) | 1 |
| Colitis | 1/11 (9.1%) | 1 |
| Constipation | 5/11 (45.5%) | 9 |
| Diarrhea | 11/11 (100%) | 33 |
| Dry mouth | 5/11 (45.5%) | 16 |
| Dyspepsia | 2/11 (18.2%) | 2 |
| Dysphagia | 2/11 (18.2%) | 3 |
| Enterocolitis | 1/11 (9.1%) | 1 |
| Fecal incontinence | 1/11 (9.1%) | 1 |
| Gastrointestinal disorders - Other, specify | 2/11 (18.2%) | 3 |
| Malabsorption | 1/11 (9.1%) | 1 |
| Mucositis oral | 4/11 (36.4%) | 5 |
| Nausea | 11/11 (100%) | 39 |
| Oral pain | 3/11 (27.3%) | 4 |
| Proctitis | 1/11 (9.1%) | 1 |
| Rectal hemorrhage | 1/11 (9.1%) | 1 |
| Salivary duct inflammation | 1/11 (9.1%) | 1 |
| Vomiting | 8/11 (72.7%) | 12 |
| General disorders | ||
| Chills | 7/11 (63.6%) | 12 |
| Edema face | 1/11 (9.1%) | 1 |
| Edema limbs | 8/11 (72.7%) | 15 |
| Facial pain | 2/11 (18.2%) | 2 |
| Fatigue | 9/11 (81.8%) | 34 |
| Fever | 11/11 (100%) | 19 |
| Flu like symptoms | 1/11 (9.1%) | 1 |
| General disorders and administration site conditions - Other, specify | 2/11 (18.2%) | 4 |
| Hypothermia | 1/11 (9.1%) | 1 |
| Localized edema | 1/11 (9.1%) | 1 |
| Malaise | 4/11 (36.4%) | 6 |
| Multi-organ failure | 2/11 (18.2%) | 3 |
| Non-cardiac chest pain | 2/11 (18.2%) | 3 |
| Pain | 7/11 (63.6%) | 13 |
| Immune system disorders | ||
| Immune system disorders - Other, specify | 4/11 (36.4%) | 9 |
| Infections and infestations | ||
| Enterocolitis infectious | 2/11 (18.2%) | 3 |
| Infections and infestations - Other, specify | 5/11 (45.5%) | 10 |
| Lung infection | 1/11 (9.1%) | 1 |
| Papulopustular rash | 2/11 (18.2%) | 4 |
| Sepsis | 2/11 (18.2%) | 4 |
| Sinusitis | 1/11 (9.1%) | 1 |
| Upper respiratory infection | 3/11 (27.3%) | 3 |
| Urinary tract infection | 1/11 (9.1%) | 1 |
| Injury, poisoning and procedural complications | ||
| Bruising | 2/11 (18.2%) | 2 |
| Fall | 1/11 (9.1%) | 2 |
| Investigations | ||
| Activated partial thromboplastin time prolonged | 1/11 (9.1%) | 1 |
| Alanine aminotransferase increased | 6/11 (54.5%) | 20 |
| Alkaline phosphatase increased | 4/11 (36.4%) | 9 |
| Aspartate aminotransferase increased | 8/11 (72.7%) | 26 |
| Blood bilirubin increased | 1/11 (9.1%) | 2 |
| Cardiac troponin I increased | 1/11 (9.1%) | 1 |
| Cholesterol high | 1/11 (9.1%) | 8 |
| Creatinine increased | 8/11 (72.7%) | 24 |
| Ejection fraction decreased | 2/11 (18.2%) | 2 |
| Electrocardiogram QT corrected interval prolonged | 1/11 (9.1%) | 1 |
| GGT increased | 3/11 (27.3%) | 6 |
| INR increased | 3/11 (27.3%) | 6 |
| Lipase increased | 1/11 (9.1%) | 1 |
| Lymphocyte count decreased | 11/11 (100%) | 58 |
| Neutrophil count decreased | 11/11 (100%) | 29 |
| Platelet count decreased | 11/11 (100%) | 59 |
| Urine output decreased | 1/11 (9.1%) | 1 |
| Weight loss | 2/11 (18.2%) | 2 |
| White blood cell decreased | 10/11 (90.9%) | 25 |
| Metabolism and nutrition disorders | ||
| Acidosis | 1/11 (9.1%) | 2 |
| Anorexia | 3/11 (27.3%) | 7 |
| Dehydration | 1/11 (9.1%) | 2 |
| Glucose intolerance | 1/11 (9.1%) | 1 |
| Hypercalcemia | 1/11 (9.1%) | 4 |
| Hyperglycemia | 3/11 (27.3%) | 19 |
| Hyperkalemia | 3/11 (27.3%) | 8 |
| Hypermagnesemia | 5/11 (45.5%) | 6 |
| Hypernatremia | 1/11 (9.1%) | 2 |
| Hypertriglyceridemia | 1/11 (9.1%) | 1 |
| Hyperuricemia | 1/11 (9.1%) | 1 |
| Hypoalbuminemia | 11/11 (100%) | 46 |
| Hypocalcemia | 5/11 (45.5%) | 15 |
| Hypokalemia | 9/11 (81.8%) | 24 |
| Hypomagnesemia | 6/11 (54.5%) | 10 |
| Hyponatremia | 7/11 (63.6%) | 24 |
| Hypophosphatemia | 2/11 (18.2%) | 3 |
| Metabolism and nutrition disorders - Other, specify | 1/11 (9.1%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 1/11 (9.1%) | 1 |
| Back pain | 4/11 (36.4%) | 5 |
| Bone pain | 1/11 (9.1%) | 1 |
| Buttock pain | 1/11 (9.1%) | 1 |
| Chest wall pain | 2/11 (18.2%) | 2 |
| Generalized muscle weakness | 2/11 (18.2%) | 4 |
| Musculoskeletal and connective tissue disorder - Other, specify | 1/11 (9.1%) | 1 |
| Neck pain | 2/11 (18.2%) | 3 |
| Pain in extremity | 1/11 (9.1%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify | 1/11 (9.1%) | 1 |
| Nervous system disorders | ||
| Depressed level of consciousness | 1/11 (9.1%) | 1 |
| Dizziness | 6/11 (54.5%) | 16 |
| Dysarthria | 1/11 (9.1%) | 1 |
| Dysgeusia | 2/11 (18.2%) | 4 |
| Headache | 9/11 (81.8%) | 21 |
| Lethargy | 1/11 (9.1%) | 1 |
| Peripheral motor neuropathy | 2/11 (18.2%) | 2 |
| Peripheral sensory neuropathy | 1/11 (9.1%) | 5 |
| Presyncope | 2/11 (18.2%) | 3 |
| Somnolence | 1/11 (9.1%) | 2 |
| Syncope | 2/11 (18.2%) | 2 |
| Tremor | 1/11 (9.1%) | 1 |
| Psychiatric disorders | ||
| Anxiety | 4/11 (36.4%) | 7 |
| Confusion | 2/11 (18.2%) | 2 |
| Delirium | 1/11 (9.1%) | 1 |
| Insomnia | 5/11 (45.5%) | 13 |
| Renal and urinary disorders | ||
| Acute kidney injury | 2/11 (18.2%) | 2 |
| Chronic kidney disease | 1/11 (9.1%) | 1 |
| Hematuria | 2/11 (18.2%) | 2 |
| Hemoglobinuria | 2/11 (18.2%) | 5 |
| Proteinuria | 1/11 (9.1%) | 4 |
| Renal and urinary disorders - Other, specify | 1/11 (9.1%) | 1 |
| Urinary frequency | 2/11 (18.2%) | 2 |
| Urinary incontinence | 1/11 (9.1%) | 1 |
| Urinary retention | 2/11 (18.2%) | 2 |
| Urinary tract pain | 1/11 (9.1%) | 1 |
| Urinary urgency | 1/11 (9.1%) | 1 |
| Reproductive system and breast disorders | ||
| Erectile dysfunction | 1/11 (9.1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Adult respiratory distress syndrome | 1/11 (9.1%) | 1 |
| Aspiration | 1/11 (9.1%) | 1 |
| Atelectasis | 2/11 (18.2%) | 2 |
| Cough | 6/11 (54.5%) | 15 |
| Dyspnea | 9/11 (81.8%) | 20 |
| Epistaxis | 2/11 (18.2%) | 3 |
| Hiccups | 3/11 (27.3%) | 3 |
| Hoarseness | 1/11 (9.1%) | 1 |
| Hypoxia | 4/11 (36.4%) | 9 |
| Nasal congestion | 4/11 (36.4%) | 6 |
| Pleural effusion | 3/11 (27.3%) | 7 |
| Pneumothorax | 1/11 (9.1%) | 1 |
| Postnasal drip | 2/11 (18.2%) | 2 |
| Productive cough | 1/11 (9.1%) | 2 |
| Pulmonary edema | 3/11 (27.3%) | 4 |
| Pulmonary hypertension | 1/11 (9.1%) | 1 |
| Respiratory failure | 2/11 (18.2%) | 4 |
| Sore throat | 6/11 (54.5%) | 10 |
| Wheezing | 2/11 (18.2%) | 2 |
| Skin and subcutaneous tissue disorders | ||
| Erythema multiforme | 1/11 (9.1%) | 1 |
| Rash acneiform | 1/11 (9.1%) | 1 |
| Rash maculo-papular | 9/11 (81.8%) | 20 |
| Skin and subcutaneous tissue disorders - Other, specify | 1/11 (9.1%) | 1 |
| Skin atrophy | 1/11 (9.1%) | 1 |
| Skin ulceration | 1/11 (9.1%) | 1 |
| Vascular disorders | ||
| Flushing | 1/11 (9.1%) | 2 |
| Hypertension | 3/11 (27.3%) | 3 |
| Hypotension | 6/11 (54.5%) | 13 |
| Thromboembolic event | 1/11 (9.1%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Vaishalee Kenkre |
|---|---|
| Organization | University of Madison Carbone Cancer Center |
| Phone | (608) 263-1699 |
| vpkenkre@medicine.wisc.edu |
- UW14113
- 2015-0996
- NCI-2015-02269
- A534260
- SMPH\MEDICINE\HEM-ONC
- Protocol Version 4/24/2020