Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer
Study Details
Study Description
Brief Summary
RATIONALE: Giving chemotherapy, such as fludarabine, busulfan, and cyclophosphamide, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells and helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving high-dose cyclophosphamide together with tacrolimus and mycophenolate mofetil after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well combination chemotherapy works when given together with a donor stem cell transplant, followed by tacrolimus, mycophenolate mofetil, and high-dose cyclophosphamide, in treating patients with high-risk hematologic cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- To estimate the incidence of graft rejection and severe graft-versus-host disease after myeloablative HLA-mismatched peripheral blood stem cell transplantation (PBSCT) from first-degree relatives in patients with high-risk hematologic malignancies.
Secondary
-
To estimate overall survival, relapse, non-relapse mortality, and event-free survival in these patients.
-
To characterize additional hematologic and non-hematologic toxicities of myeloablative haploidentical PBSCT.
-
To characterize donor hematopoietic chimerism in peripheral blood stem cells after PBSCT.
OUTLINE:
-
Preparative regimen: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -2, busulfan IV over 3 hours on days -7 to -4, and cyclophosphamide IV over 1-2 hours on days -3 and -2.
-
Allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo infusion of unmanipulated peripheral blood stem cells on day 0.
-
Post-transplant regimen: Patients receive high-dose cyclophosphamide IV over 1-2 hours on days 3 and 4, tacrolimus IV over 24 hours or orally twice daily on days 5-180, and oral mycophenolate mofetil 3 times daily on days 5-34 followed by a taper to day 90. Treatment continues in the absence of disease progression or clinically significant graft-vs-host disease.
After completion of PBSCT, patients are followed periodically for 1 year.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Myeloablative Haploidentical Transplant All patients will receive treatment using Fludarabine, Busulfan and Cyclophosphamide prior to receiving a haploidentical transplant followed by post-transplant cyclosphosphamide. |
Drug: busulfan
110 mg/m2 infused over 3 hours once daily on 4 consecutive days (Days -7, -6, -5, -4)
Drug: cyclophosphamide
14.5 mg/kg infused over 1-2 hours once daily on 2 consecutive days (days -3,-2).
Drug: fludarabine phosphate
30mg/m2 infused over 30 minutes once daily on three consecutive days (days -5, -4, -3)
Drug: mycophenolate mofetil
15 mg/kg po three times a daily with a maximum dose of 3gm/day starting D+5. To be discontinued on Day +35 in the absence of clinically significant GVHD.
Other Names:
Drug: tacrolimus
0.03 mg/kg/day infuse over 24 hours starting on day +5 (adjusted to maintain trough level of 5-15 ng/ml). Switch to oral (twice daily divided dose) on day +21 or when able to tolerate PO. Discontinue on day +180 in the absence of clinically significant GVHD.
Other Names:
Procedure: allogeneic hematopoietic stem cell transplantation
Patients to received unmanipulated PBSCs on Day 0
Other Names:
Procedure: peripheral blood stem cell transplantation
patients to receive unmanipulated PBSCs on day 0
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Graft Rejection for Patients at Day 100 [Day 100]
Number of patients who experienced graft rejection by Day 100
- Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4) [Day 100]
Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence
Secondary Outcome Measures
- Overall Survival at Day 100 [Day 100]
Overall survival is assessed, without regard to disease status, post-transplant, at Day 100.
- Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT) [1 year]
Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease.
- Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation [Day 30]
Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) [Day 100]
- Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation [Day 60]
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation [Day 90]
Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism.
- Overall Survival at 12 Months [12 months]
Overall survival, defined as a patient being alive after transplant, is without regard to disease status.
- Disease Free Survival at 12 Months [12 months]
Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point.
- Disease Free Survival at Day 100 [Day 100]
Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of one of the following high-risk hematologic malignancies:
-
Chronic myelogenous leukemia meeting one of the following criteria:
-
Disease in chronic phase and resistant to available tyrosine kinase inhibitors
-
Disease in accelerated phase
-
Disease with blast crisis that has entered into a second chronic phase after induction chemotherapy
-
Acute myelogenous leukemia meeting the following criteria:
-
Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
-
Must meet one of the following criteria:
-
Disease in second or subsequent complete remission
-
Primary induction chemotherapy failure with disease subsequently entering complete remission
-
Disease in first complete remission with poor-risk cytogenetics or arising from preceding hematological disease
-
Myelodysplastic syndrome meeting at least one of the following criteria:
-
Treatment-related
-
Monosomy 7 or complex cytogenetics
-
International prognostic scoring system score ≥ 1.5
-
Chronic myelomonocytic leukemia
-
Acute lymphocytic leukemia or lymphoblastic lymphoma meeting the following criteria:
-
Marrow blasts < 5% but persistence of minimal residual disease by flow cytometry, cytogenetics, or FISH
-
Must meet one of the following criteria:
-
Disease in second or subsequent complete remission
-
Acute lymphocytic leukemia with poor-risk karyotype [e.g., t(9;22) or bcr-abl fusion, t(4;11), or other MLL translocation] and in first complete remission
-
Chronic lymphocytic leukemia or prolymphocytic leukemia meeting both of the following criteria:
-
Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy including purine analogs
-
In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy)
-
Hodgkin or non-Hodgkin lymphoma (including low-grade, mantle cell, and intermediate-grade/diffuse disease) meeting the following criteria:
-
Previously treated disease that has either relapsed or failed to respond adequately to conventional-dose therapy or autologous transplantation
-
In the opinion of the transplant physician, unlikely to benefit from reduced intensity transplantation due to the presence of one or more high-risk features (i.e., bulky tumor masses, B symptoms, and/or inadequate response to salvage chemotherapy) NOTE: A new classification scheme for adult non-Hodgkin lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.
-
No available matched related or unrelated donor OR a matched related or unrelated donor will not be available in the time frame necessary to perform a transplant
-
Availability of a first-degree relative (parent, child, sibling) matched at 3/6-5/6 loci (HLA-A, -B, -DR)
-
Donor must be willing to donate mobilized peripheral blood stem cells
-
No positive HLA crossmatch in the host-vs-graft direction or high titer donor-specific antibodies
PATIENT CHARACTERISTICS:
-
Karnofsky performance status 70-100%
-
Bilirubin < 2 mg/dL (unless due to hemolysis, Gilbert syndrome, or primary malignancy)
-
Creatinine < 2 mg/dL OR creatinine clearance ≥ 40 mL/min
-
Not pregnant
-
Fertile patients must use effective contraception
-
LVEF (Left ventriculr ejection fraction) ≥ 45%
-
FEV_1 and forced vital capacity ≥ 50% predicted
-
No HIV positivity
-
No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
-
No immunosuppressive agents ≤ 24 hours after completion of post-transplant cyclophosphamide (including steroids as antiemetics)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | United States | 30342 |
Sponsors and Collaborators
- Northside Hospital, Inc.
Investigators
- Principal Investigator: Scott R. Solomon, MD, Blood and Marrow Transplant Group of Georgia
- Principal Investigator: H. Kent Holland, MD, Blood and Marrow Transplant Group of Georgia
- Principal Investigator: Asad Bashey, MD, PhD, Blood and Marrow Transplant Group of Georgia
- Principal Investigator: Lawrence E. Morris, MD, Blood and Marrow Transplant Group of Georgia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000617648
- BMTGG-NSH-864
Study Results
Participant Flow
| Recruitment Details | Patients were consented between 12/17/08 through 01/13/11. The transplants occured between 1/13/09 and 3/2/11 |
|---|---|
| Pre-assignment Detail | NA - this study did not use group assignments. All patients received the same preparative regimen consisting of Fludarabine 25 mg/m2 x 5 days, busulfan 110 mg/m2 x4 days, cyclophosphamide 14.5 mg x 2 days PRE transplant and cyclophosphamide 50 mg x2 days POST transplant |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Period Title: Overall Study | |
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Overall Participants | 20 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
20
100%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
41.75
(8.67)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
11
55%
|
| Male |
9
45%
|
| Region of Enrollment (participants) [Number] | |
| United States |
20
100%
|
Outcome Measures
| Title | Incidence of Graft Rejection for Patients at Day 100 |
|---|---|
| Description | Number of patients who experienced graft rejection by Day 100 |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 patients were treated and able to be analyzed for graft rejection |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 20 |
| Number [participants] |
0
0%
|
| Title | Number of Patients Who Experienced Severe Graft-versus-host Disease (GVHD)(Grade 3 or 4) |
|---|---|
| Description | Number of patients who experienced post-transplant complication (GVHD) as seen by clinical evidence |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 patients were alive at Day 100 and eligible to be evaluated for grade 3-4 graft versus host disease |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 17 |
| Number [participants] |
2
10%
|
| Title | Overall Survival at Day 100 |
|---|---|
| Description | Overall survival is assessed, without regard to disease status, post-transplant, at Day 100. |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 patients received a haploidentical transplant and therefore are eligible to be evaluated for Day 100 survival |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 20 |
| Number [participants] |
17
85%
|
| Title | Non-relapse Mortality at 1 Year After Peripheral Blood Stem Cell Transplantation (PBSCT) |
|---|---|
| Description | Non-relapse mortality refers to whether a patient dies of causes related to something other than the primary disease. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| 6 patients died prior to one year and therefore are eligible to be evaluated for non-relapse mortality. |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 6 |
| Number [participants] |
2
10%
|
| Title | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 30 Post-transplantation |
|---|---|
| Description | Chimerism analysis of peripheral blood mononuclear cells using PCR (polymerase chain reaction) for STR/VNTR (short tandme repeat/variable number tandem repeat) will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. |
| Time Frame | Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 18 patients had Day 30 chimerism drawn |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 18 |
| Number [participants] |
18
90%
|
| Title | Non-relapse Mortality at Day 100 After Peripheral Blood Stem Cell Transplantation (PBSCT) |
|---|---|
| Description | |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 2 patients died before Day 100 and therefore are eligible to be evaluated for non-relapse mortality |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 2 |
| Number [participants] |
2
10%
|
| Title | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 60 Post-transplantation |
|---|---|
| Description | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. |
| Time Frame | Day 60 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 18 patients had chimerism drawn at Day 60 |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 18 |
| Number [participants] |
18
90%
|
| Title | Achievement of >90% (Full) Donor Chimerism in the T-Cell Lineage as Measured by PCR at Day 90 Post-transplantation |
|---|---|
| Description | Chimerism analysis of peripheral blood mononuclear cells using PCR for STR/VNTR will be performed post transplant. On each occasion, the peripheral blood will be separated into the T-cell component (using e.g. CD3 selection) and the myeloid component (using e.g.CD14/15 selection) before assessment of chimerism. |
| Time Frame | Day 90 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 13 patients had chimerism drawn at Day 90 |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 13 |
| Number [participants] |
13
65%
|
| Title | Overall Survival at 12 Months |
|---|---|
| Description | Overall survival, defined as a patient being alive after transplant, is without regard to disease status. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 20 patients received haploidentical transplant and therefore were eligible to be evaluated for overall survival at 1 year |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 20 |
| Number [participants] |
14
70%
|
| Title | Disease Free Survival at 12 Months |
|---|---|
| Description | Disease free survival refers to patients with no evidence of disease after transplant, at the 12 month time point. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 14 patients were alive at one year and therefore were eligible to be evaluated for disease free survival at 1 year |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 14 |
| Number [participants] |
7
35%
|
| Title | Disease Free Survival at Day 100 |
|---|---|
| Description | Disease free survival refers to patients with no evidence of disease after transplant, at the Day 100 time point. |
| Time Frame | Day 100 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 17 patients were alive at Day 100 and therefore were eligible to be evaluated for disease free survival at D100 |
| Arm/Group Title | Haploidentical Transplant |
|---|---|
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant |
| Measure Participants | 17 |
| Number [participants] |
16
80%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | Adverse Events (AEs) regardless of grade were recorded for 6mo post-transplant. Serious Adverse Events (SAEs) were reported within 24hrs of notification. Patients with baseline AE that did not experience an increase in grade (remained the same grade or lesser)were not included in the totals. | |
| Arm/Group Title | Haploidentical Transplant | |
| Arm/Group Description | Patients receiving Fludarabine, Busulfan, cyclophosphamide and post-transplant cyclophosphamide for a haploidentical donor transplant | |
All Cause Mortality |
||
| Haploidentical Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Haploidentical Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | 12/20 (60%) | |
| Cardiac disorders | ||
| Chest pain | 1/20 (5%) | 1 |
| Gastrointestinal disorders | ||
| Ascites | 1/20 (5%) | 1 |
| Colitis | 2/20 (10%) | 2 |
| General disorders | ||
| Death | 2/20 (10%) | 2 |
| Immune system disorders | ||
| Acute graft versus host disease | 1/20 (5%) | 1 |
| Infections and infestations | ||
| BK virus | 1/20 (5%) | 1 |
| Infection with normal ANC | 1/20 (5%) | 1 |
| pneumonia | 2/20 (10%) | 2 |
| Nervous system disorders | ||
| Confusion | 1/20 (5%) | 1 |
| Hypoglycemia induced hemiparesis | 1/20 (5%) | 1 |
| Renal and urinary disorders | ||
| Hemorrhagic Cystitis | 1/20 (5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Respiratory Insufficiency | 1/20 (5%) | 1 |
| pericardial effusion | 1/20 (5%) | 1 |
| respiratory failure | 1/20 (5%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Haploidentical Transplant | ||
| Affected / at Risk (%) | # Events | |
| Total | 20/20 (100%) | |
| Blood and lymphatic system disorders | ||
| ANC | 17/20 (85%) | 17 |
| Anemia | 18/20 (90%) | 18 |
| edema | 5/20 (25%) | 5 |
| fluid overload | 6/20 (30%) | 6 |
| hyperkalemia | 12/20 (60%) | 12 |
| hypermagnesemia | 2/20 (10%) | 2 |
| hypernatremia | 9/20 (45%) | 9 |
| increased PT | 2/20 (10%) | 2 |
| LE edema | 10/20 (50%) | 10 |
| thrombocytopenia | 17/20 (85%) | 17 |
| Decreased WBC | 18/20 (90%) | 18 |
| Cardiac disorders | ||
| bradycardia | 2/20 (10%) | 2 |
| cardiomyopathy | 3/20 (15%) | 3 |
| decreased EF | 2/20 (10%) | 2 |
| hypertension | 11/20 (55%) | 11 |
| hypotension | 8/20 (40%) | 8 |
| tachycardia | 19/20 (95%) | 19 |
| Ear and labyrinth disorders | ||
| hearing loss | 2/20 (10%) | 2 |
| Eye disorders | ||
| dry eyes | 2/20 (10%) | 2 |
| periorbital edema | 2/20 (10%) | 2 |
| visual changes | 2/20 (10%) | 2 |
| Gastrointestinal disorders | ||
| abdominal cramping | 10/20 (50%) | 10 |
| abdominal distension | 6/20 (30%) | 6 |
| abdominal pain | 9/20 (45%) | 9 |
| abdominal tenderness | 3/20 (15%) | 3 |
| abnormal taste | 2/20 (10%) | 2 |
| Altered taste | 2/20 (10%) | 2 |
| Ascites | 2/20 (10%) | 2 |
| bloating | 2/20 (10%) | 2 |
| constipation | 8/20 (40%) | 8 |
| diarrhea | 19/20 (95%) | 19 |
| difficulty swallowing | 3/20 (15%) | 3 |
| dry mouth | 5/20 (25%) | 5 |
| esophagitis | 5/20 (25%) | 5 |
| flatulence | 5/20 (25%) | 5 |
| GERD/dyspepsia | 14/20 (70%) | 14 |
| GI distress | 3/20 (15%) | 3 |
| increased oral secretions | 2/20 (10%) | 2 |
| mucositis | 20/20 (100%) | 20 |
| nausea | 19/20 (95%) | 19 |
| rectal discomfort | 3/20 (15%) | 3 |
| sore throat | 7/20 (35%) | 7 |
| stool incontinence | 5/20 (25%) | 5 |
| throat pain | 4/20 (20%) | 4 |
| vomitting | 19/20 (95%) | 19 |
| General disorders | ||
| Constitutional - feeling cold | 2/20 (10%) | 2 |
| chills | 15/20 (75%) | 15 |
| dizziness | 5/20 (25%) | 5 |
| drowsiness | 5/20 (25%) | 5 |
| epistaxis | 4/20 (20%) | 4 |
| fatigue | 19/20 (95%) | 19 |
| fever | 18/20 (90%) | 18 |
| general deconditioning | 4/20 (20%) | 4 |
| headache | 7/20 (35%) | 7 |
| hiccoughs | 2/20 (10%) | 2 |
| insomnia | 14/20 (70%) | 14 |
| lethargy | 6/20 (30%) | 6 |
| neutropenic fever | 6/20 (30%) | 6 |
| night sweats | 4/20 (20%) | 4 |
| pain | 5/20 (25%) | 5 |
| restlessness | 3/20 (15%) | 3 |
| rigors | 2/20 (10%) | 2 |
| suprapubic pain | 3/20 (15%) | 3 |
| unsteady gait | 2/20 (10%) | 2 |
| weakness | 9/20 (45%) | 9 |
| weight gain | 2/20 (10%) | 2 |
| weight loss | 3/20 (15%) | 3 |
| Hepatobiliary disorders | ||
| ALT | 17/20 (85%) | 17 |
| AST | 12/20 (60%) | 12 |
| hyperbilirubinemia | 8/20 (40%) | 8 |
| Immune system disorders | ||
| hives | 2/20 (10%) | 2 |
| seasonal allergies | 3/20 (15%) | 3 |
| Infections and infestations | ||
| BK virus | 15/20 (75%) | 15 |
| c-diff | 7/20 (35%) | 7 |
| CMV | 11/20 (55%) | 11 |
| Coag Neg Staph | 2/20 (10%) | 2 |
| gram + bacteremia | 2/20 (10%) | 2 |
| MRSE | 2/20 (10%) | 2 |
| parainfluenza | 5/20 (25%) | 5 |
| RSV | 2/20 (10%) | 2 |
| staph epi | 4/20 (20%) | 4 |
| thrush | 2/20 (10%) | 2 |
| VRE | 4/20 (20%) | 4 |
| Investigations | ||
| hypercalcemia | 11/20 (55%) | 20 |
| hyperglycemia | 19/20 (95%) | 20 |
| hyperphosphatemia | 3/20 (15%) | 3 |
| hypoalbuminemia | 15/20 (75%) | 15 |
| hypocalcemia | 14/20 (70%) | 14 |
| hypoglycemia | 4/20 (20%) | 4 |
| hypokalemia | 15/20 (75%) | 15 |
| hypomagnesemia | 18/20 (90%) | 18 |
| hyponatremia | 12/20 (60%) | 12 |
| hypophosphatemia | 4/20 (20%) | 4 |
| Metabolism and nutrition disorders | ||
| ALK PHOS | 2/20 (10%) | 2 |
| Anorexia/decreased appetite | 17/20 (85%) | 17 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 3/20 (15%) | 3 |
| Back pain | 7/20 (35%) | 7 |
| myalgia | 8/20 (40%) | 8 |
| neck pain | 3/20 (15%) | 3 |
| neck stiffness | 2/20 (10%) | 2 |
| shoulder discomfort | 2/20 (10%) | 2 |
| Nervous system disorders | ||
| agitation | 6/20 (30%) | 6 |
| peripheral neuropathy | 9/20 (45%) | 9 |
| tremors | 4/20 (20%) | 4 |
| Psychiatric disorders | ||
| Anxiety | 16/20 (80%) | 16 |
| confusion | 6/20 (30%) | 6 |
| depression | 13/20 (65%) | 13 |
| flat affect | 4/20 (20%) | 4 |
| hallucinations | 2/20 (10%) | 2 |
| Renal and urinary disorders | ||
| Bladder pain | 5/20 (25%) | 5 |
| Bladder pressure | 4/20 (20%) | 4 |
| bladder spasms | 7/20 (35%) | 7 |
| creatinine | 14/20 (70%) | 14 |
| hematuria | 10/20 (50%) | 10 |
| hemorrhagic cystitis | 4/20 (20%) | 4 |
| renal insufficiency | 5/20 (25%) | 5 |
| urinary burning | 3/20 (15%) | 3 |
| urinary frequency | 9/20 (45%) | 9 |
| urinary incontinence | 3/20 (15%) | 3 |
| urinary urgency | 5/20 (25%) | 5 |
| Reproductive system and breast disorders | ||
| penile pain | 3/20 (15%) | 3 |
| vaginal spotting/bleeding | 3/20 (15%) | 3 |
| Respiratory, thoracic and mediastinal disorders | ||
| Alveolar hemorrhage | 2/20 (10%) | 2 |
| cough | 17/20 (85%) | 17 |
| hemoptysis | 2/20 (10%) | 2 |
| hypoxia | 3/20 (15%) | 3 |
| nasal congestion | 4/20 (20%) | 4 |
| pleural effusion | 3/20 (15%) | 3 |
| pulmonary infiltrates | 2/20 (10%) | 2 |
| reactive airway disease | 2/20 (10%) | 2 |
| respiratory failure | 2/20 (10%) | 2 |
| rhinorrhea | 5/20 (25%) | 5 |
| shortness of breath | 9/20 (45%) | 9 |
| sinus congestion | 4/20 (20%) | 4 |
| sinus drainage | 3/20 (15%) | 3 |
| sinusitis | 4/20 (20%) | 4 |
| tachypnea | 2/20 (10%) | 2 |
| wheezing | 3/20 (15%) | 3 |
| Skin and subcutaneous tissue disorders | ||
| bruising | 3/20 (15%) | 3 |
| cvc bleeding | 2/20 (10%) | 2 |
| cvc erythema | 4/20 (20%) | 4 |
| cvc tenderness/pain | 4/20 (20%) | 4 |
| diaphoresis | 2/20 (10%) | 2 |
| dry lips | 3/20 (15%) | 3 |
| dry skin | 9/20 (45%) | 9 |
| erythema | 3/20 (15%) | 3 |
| facial edema | 3/20 (15%) | 3 |
| hemorrhoids | 2/20 (10%) | 2 |
| hyperpigmented skin | 7/20 (35%) | 7 |
| hypopigmentation | 2/20 (10%) | 2 |
| lip lesion | 2/20 (10%) | 2 |
| pruritis | 18/20 (90%) | 18 |
| rash | 15/20 (75%) | 15 |
| skin discoloration | 2/20 (10%) | 2 |
| skin tear | 2/20 (10%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Scott Solomon |
|---|---|
| Organization | Blood and Marrow Transplant Group of Georgia |
| Phone | 404-255-1930 |
| ssolomon@bmtga.com |
- CDR0000617648
- BMTGG-NSH-864