Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant
Study Details
Study Description
Brief Summary
RATIONALE: Giving chemotherapy, such as busulfan and fludarabine phosphate, before a peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, tacrolimus, and antithymocyte globulin before and after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect.
PURPOSE: This phase II trial is studying how well donor stem cell transplant works in treating patients with relapsed hematologic malignancies or secondary myelodysplasia previously treated with high-dose chemotherapy and autologous stem cell transplant .
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
-
To demonstrate the efficacy of performing reduced-intensity conditioning allogeneic hematopoietic cell transplantation in patients with relapsed hematologic malignancies or secondary myelodysplasia after completion of prior high-dose chemotherapy and autologous hematopoietic stem cell transplantation.
-
To compare the strategy of this regimen with the strategy used in CALGB-100002.
Secondary
-
To describe the response rate at 6 and 12 months in patients treated with this regimen.
-
To describe the time-to-progression in patients treated with this regimen.
-
To determine the ability to use pharmacokinetic-directed busulfan to achieve AUC within 20% of target AUC in > 80% of patients.
-
To determine percent of donor chimerism in T-cell, myeloid and B-cell populations achieved with this regimen compared with CALGB-100002.
-
To determine the risk of acute and chronic graft-versus-host disease and other toxicities of this regimen in these patients.
-
To describe the overall survival and disease-free survival of patients treated on this regimen.
-
To determine the rate of viral, bacterial, and fungal opportunistic infections occurring in the first year after transplantation compared with CALGB-100002.
OUTLINE: This is a multicenter study.
-
Preparative Regimen:
-
Busulfan test dose: Patients receive busulfan IV over 45 minutes once during days -14 and -9.
-
Busulfan treatment dose: Patients receive fludarabine phosphate IV over 30 minutes on days -7 to -3 and busulfan IV over 3 hours on days -6 to -3.
-
Graft-vs-Host Disease (GVHD) Prophylaxis:
-
HLA-identical donor: Patients receive antithymocyte globulin IV over 6-10 hours on days -6 to -5; oral tacrolimus twice daily on days -2 to 90 followed by a taper* as tolerated until day 150 or 180; and methotrexate IV on days 1, 3, and 6.
NOTE: * Tacrolimus may be tapered on days 60-90 if donor chimerism of CD3+ cells is < 50% at day 60 or patient has progressive disease.
-
Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60.
-
Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover.
-
Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks.
Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Matched-unrelated donor: Patients receive antithymocyte globulin, tacrolimus, and methotrexate as in HLA-identical donor regimen. Patients also receive oral mycophenolate mofetil twice daily on days 0 to 60. Allogeneic Stem Cell Transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation on days 0 and 1. Patients then receive filgrastim subcutaneously daily beginning on day 7 and continuing until blood counts recover. Donor Lymphocyte Infusion (DLI): After day 180 (or day 210 for patients without an HLA-identical donor), patients with stable or progressive disease and no active GVHD may receive up to 3 DLIs every 8 weeks. Blood samples are collected at baseline and then periodically during study therapy for pharmacokinetic studies. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for up to 5½ years. |
Biological: anti-thymocyte globulin
Biological: donor lymphocytes
Biological: filgrastim
Biological: therapeutic allogeneic lymphocytes
Drug: busulfan
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Other: reduced-intensity transplant conditioning procedure
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation
|
Outcome Measures
Primary Outcome Measures
- Event-free Survival (EFS) [Duration of study (up to 5.5 years)]
EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method.
- Comparison of EFS Distribution to That of CALGB-100002 [2 years]
EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test.
Secondary Outcome Measures
- Complete Response Rate [Up to 5.5 years]
Complete response (CR) rate is reported as the percentage of participants who achieved a CR.
- Overall Survival [Up to 5.5 years]
Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method.
- Rate of Opportunistic Infections [1 year post transplant]
Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed hematologic malignancies:
-
Chronic lymphocytic leukemia (CLL) or prolymphocytic leukemia (PLL)
-
Absolute lymphocytosis of > 5,000/μL
-
Lymphocytes must appear morphologically mature with < 55% prolymphocytes (CLL)
-
Patients with > 55% prolymphocytes are considered as having PLL
-
Lymphocyte phenotype with expression of CD20, CD19, and CD5 (CLL)
-
Non-Hodgkin lymphoma
-
Any WHO classification of histologic subtype
-
Core biopsies acceptable for primary diagnosis and immunophenotyping
-
Bone marrow biopsies as sole means of diagnosis not allowed for follicular lymphoma
-
Hodgkin lymphoma
-
Any WHO classification of histologic subtype
-
Core biopsies acceptable for primary diagnosis and immunophenotyping
-
Bone marrow biopsy is required
-
Multiple myeloma
-
Patients must have active disease requiring treatment (Durie-Salmon stage I-III)
-
Acute myeloid leukemia
-
Must have < 10% bone marrow blasts and no circulating blasts
-
Myelodysplastic syndrome (MDS)
-
MDS as define by WHO criteria
-
Must have < 10% marrow blasts
-
Relapsed or progressive disease or myelodysplasia ≥ 6 months after prior high-dose chemotherapy with autologous hematopoietic cell support
-
Prior syngeneic transplantation allowed
-
Healthy donor meeting one of the following criteria:
-
HLA-identical sibling (6/6)
-
Serologic typing for class I (A, B) and molecular typing for class II (DRB1) required
-
8/8 matched-unrelated donor
-
Molecular identity at HLA A, B, C, and DRB1 by high-resolution typing required
-
No syngeneic donors
PATIENT CHARACTERISTICS:
-
Creatinine clearance ≥ 40 mL/min
-
Total bilirubin ≤ 2 mg/dL
-
AST ≤ 3 times upper limit of normal
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception
-
DLCO ≥ 40% with no symptomatic pulmonary disease
-
LVEF ≥ 30% by MUGA or ECHO
-
No uncontrolled diabetes mellitus or active serious infection
-
No known hypersensitivity to E.coli-derived products
-
No HIV infection
PRIOR CONCURRENT THERAPY:
-
See Disease Characteristics
-
At least 4 weeks should elapse between prior standard cytotoxic chemotherapy, radiation therapy, or surgery and the planned start of the preparative regimen on day -7
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 2 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 3 | Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando | Florida | United States | 32803-1273 |
| 4 | Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 5 | Union Hospital of Cecil County | Elkton MD | Maryland | United States | 21921 |
| 6 | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Saint Louis | Missouri | United States | 63110 |
| 7 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 8 | New York Weill Cornell Cancer Center at Cornell University | New York | New York | United States | 10021 |
| 9 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 10 | Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer Center | Columbus | Ohio | United States | 43210-1240 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Asad Bashey, MD, PhD, Blood and Marrow Transplant Group of Georgia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CALGB-100601
- CALGB-100601
- CDR0000667954
Study Results
Participant Flow
| Recruitment Details | Between May 2010 and March 2012, 6 participants were recruited. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Period Title: Overall Study | |
| STARTED | 6 |
| COMPLETED | 6 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Overall Participants | 6 |
| Age (years) [Median (Full Range) ] | |
| Median (Full Range) [years] |
67
|
| Sex: Female, Male (Count of Participants) | |
| Female |
5
83.3%
|
| Male |
1
16.7%
|
| 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 |
6
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
6
100%
|
Outcome Measures
| Title | Event-free Survival (EFS) |
|---|---|
| Description | EFS was defined as the date of transplant to date of progression or develop myelodysplasia after autologous transplant. EFS was estimated using the Kaplan Meier method. |
| Time Frame | Duration of study (up to 5.5 years) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to study termination, data were not collected and the outcome measure was not analyzed. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Measure Participants | 0 |
| Title | Comparison of EFS Distribution to That of CALGB-100002 |
|---|---|
| Description | EFS distributions between CALGB-100002 and this study will be compared using the two-sample log-rank test. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to study termination, data were not collected and the outcome measure was not analyzed. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Measure Participants | 0 |
| Title | Complete Response Rate |
|---|---|
| Description | Complete response (CR) rate is reported as the percentage of participants who achieved a CR. |
| Time Frame | Up to 5.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to study termination, data were not collected and the outcome measure was not analyzed. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Measure Participants | 0 |
| Title | Overall Survival |
|---|---|
| Description | Overall survival (OS) was defined as the transplant from registration to death of any cause. Surviving patients were censored at the date of last follow-up. The median OS with 95% confidence interval (CI) was estimated using the Kaplan Meier method. |
| Time Frame | Up to 5.5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to study termination, data were not collected and the outcome measure was not analyzed. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Measure Participants | 0 |
| Title | Rate of Opportunistic Infections |
|---|---|
| Description | Percent of participants who have an opportunistic (viral, bacterial and fungal) infection in the first year following transplant. |
| Time Frame | 1 year post transplant |
Outcome Measure Data
| Analysis Population Description |
|---|
| Due to study termination, data were not collected and the outcome measure was not analyzed. |
| Arm/Group Title | Treatment |
|---|---|
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Treatment | |
| Arm/Group Description | Participants will receive: Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days. | |
All Cause Mortality |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/6 (50%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 1/6 (16.7%) | 1 |
| Cardiac disorders | ||
| Sinus tachycardia | 1/6 (16.7%) | 1 |
| Eye disorders | ||
| Cataract | 1/6 (16.7%) | 1 |
| Flashing lights | 1/6 (16.7%) | 1 |
| Watering eyes | 1/6 (16.7%) | 1 |
| Gastrointestinal disorders | ||
| Nausea | 1/6 (16.7%) | 1 |
| General disorders | ||
| Death NOS | 1/6 (16.7%) | 1 |
| Edema limbs | 1/6 (16.7%) | 1 |
| Fatigue | 2/6 (33.3%) | 2 |
| Fever | 1/6 (16.7%) | 1 |
| Malaise | 1/6 (16.7%) | 1 |
| Non-cardiac chest pain | 1/6 (16.7%) | 1 |
| Pain | 1/6 (16.7%) | 1 |
| Infections and infestations | ||
| Infections and infestations - Other, specify | 1/6 (16.7%) | 1 |
| Upper respiratory infection | 1/6 (16.7%) | 1 |
| Investigations | ||
| Creatinine increased | 2/6 (33.3%) | 2 |
| Neutrophil count decreased | 1/6 (16.7%) | 1 |
| Platelet count decreased | 2/6 (33.3%) | 2 |
| Weight loss | 1/6 (16.7%) | 1 |
| White blood cell decreased | 1/6 (16.7%) | 1 |
| Metabolism and nutrition disorders | ||
| Anorexia | 1/6 (16.7%) | 1 |
| Hyperglycemia | 2/6 (33.3%) | 2 |
| Hyperkalemia | 1/6 (16.7%) | 1 |
| Hypocalcemia | 1/6 (16.7%) | 1 |
| Hyponatremia | 1/6 (16.7%) | 1 |
| Musculoskeletal and connective tissue disorders | ||
| Myalgia | 1/6 (16.7%) | 1 |
| Pain in extremity | 2/6 (33.3%) | 2 |
| Nervous system disorders | ||
| Ataxia | 1/6 (16.7%) | 1 |
| Dysgeusia | 1/6 (16.7%) | 1 |
| Tremor | 1/6 (16.7%) | 1 |
| Psychiatric disorders | ||
| Agitation | 1/6 (16.7%) | 1 |
| Anxiety | 1/6 (16.7%) | 1 |
| Delirium | 1/6 (16.7%) | 1 |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/6 (16.7%) | 1 |
| Hematuria | 1/6 (16.7%) | 1 |
| Renal and urinary disorders - Other, specify | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Bronchospasm | 1/6 (16.7%) | 1 |
| Dyspnea | 1/6 (16.7%) | 1 |
| Hypoxia | 1/6 (16.7%) | 1 |
| Pneumonitis | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Skin and subcutaneous tissue disorders - Other, specify | 1/6 (16.7%) | 1 |
| Skin ulceration | 1/6 (16.7%) | 1 |
| Vascular disorders | ||
| Hypotension | 1/6 (16.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Treatment | ||
| Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 6/6 (100%) | 18 |
| Febrile neutropenia | 3/6 (50%) | 3 |
| Cardiac disorders | ||
| Cardiac disorders - Other, specify | 2/6 (33.3%) | 2 |
| Heart failure | 1/6 (16.7%) | 1 |
| Pericardial effusion | 2/6 (33.3%) | 3 |
| Sinus bradycardia | 1/6 (16.7%) | 1 |
| Sinus tachycardia | 1/6 (16.7%) | 3 |
| Ventricular arrhythmia | 1/6 (16.7%) | 1 |
| Ventricular tachycardia | 1/6 (16.7%) | 1 |
| Eye disorders | ||
| Blurred vision | 1/6 (16.7%) | 1 |
| Cataract | 1/6 (16.7%) | 1 |
| Dry eye | 1/6 (16.7%) | 2 |
| Watering eyes | 1/6 (16.7%) | 1 |
| Gastrointestinal disorders | ||
| Constipation | 3/6 (50%) | 4 |
| Diarrhea | 4/6 (66.7%) | 7 |
| Dry mouth | 3/6 (50%) | 6 |
| Dysphagia | 1/6 (16.7%) | 1 |
| Enterocolitis | 1/6 (16.7%) | 1 |
| Mucositis oral | 6/6 (100%) | 6 |
| Nausea | 3/6 (50%) | 6 |
| Oral pain | 3/6 (50%) | 3 |
| Vomiting | 3/6 (50%) | 5 |
| General disorders | ||
| Chills | 2/6 (33.3%) | 2 |
| Edema limbs | 3/6 (50%) | 4 |
| Fatigue | 4/6 (66.7%) | 12 |
| Fever | 3/6 (50%) | 8 |
| Pain | 2/6 (33.3%) | 3 |
| Infections and infestations | ||
| Catheter related infection | 2/6 (33.3%) | 2 |
| Infections and infestations - Other, specify | 3/6 (50%) | 7 |
| Lung infection | 1/6 (16.7%) | 1 |
| Meningitis | 1/6 (16.7%) | 1 |
| Mucosal infection | 1/6 (16.7%) | 1 |
| Sepsis | 2/6 (33.3%) | 2 |
| Upper respiratory infection | 2/6 (33.3%) | 2 |
| Injury, poisoning and procedural complications | ||
| Bruising | 1/6 (16.7%) | 1 |
| Investigations | ||
| Activated partial thromboplastin time prolonged | 2/6 (33.3%) | 2 |
| Alanine aminotransferase increased | 5/6 (83.3%) | 13 |
| Alkaline phosphatase increased | 3/6 (50%) | 5 |
| Aspartate aminotransferase increased | 5/6 (83.3%) | 13 |
| Blood bilirubin increased | 2/6 (33.3%) | 2 |
| Cholesterol high | 1/6 (16.7%) | 1 |
| Creatinine increased | 6/6 (100%) | 16 |
| GGT increased | 1/6 (16.7%) | 1 |
| INR increased | 2/6 (33.3%) | 2 |
| Investigations - Other, specify | 2/6 (33.3%) | 3 |
| Lymphocyte count decreased | 1/6 (16.7%) | 1 |
| Neutrophil count decreased | 6/6 (100%) | 13 |
| Platelet count decreased | 6/6 (100%) | 18 |
| Weight loss | 4/6 (66.7%) | 5 |
| White blood cell decreased | 2/6 (33.3%) | 8 |
| Metabolism and nutrition disorders | ||
| Anorexia | 4/6 (66.7%) | 9 |
| Dehydration | 1/6 (16.7%) | 1 |
| Hyperglycemia | 6/6 (100%) | 13 |
| Hyperkalemia | 1/6 (16.7%) | 1 |
| Hypermagnesemia | 1/6 (16.7%) | 1 |
| Hypertriglyceridemia | 1/6 (16.7%) | 1 |
| Hyperuricemia | 1/6 (16.7%) | 1 |
| Hypoalbuminemia | 3/6 (50%) | 7 |
| Hypocalcemia | 3/6 (50%) | 7 |
| Hypokalemia | 2/6 (33.3%) | 9 |
| Hypomagnesemia | 3/6 (50%) | 6 |
| Hyponatremia | 4/6 (66.7%) | 10 |
| Hypophosphatemia | 2/6 (33.3%) | 3 |
| Musculoskeletal and connective tissue disorders | ||
| Avascular necrosis | 1/6 (16.7%) | 2 |
| Back pain | 2/6 (33.3%) | 2 |
| Generalized muscle weakness | 3/6 (50%) | 3 |
| Myalgia | 1/6 (16.7%) | 1 |
| Pain in extremity | 1/6 (16.7%) | 1 |
| Trismus | 1/6 (16.7%) | 2 |
| Nervous system disorders | ||
| Dizziness | 2/6 (33.3%) | 3 |
| Dysgeusia | 2/6 (33.3%) | 4 |
| Headache | 1/6 (16.7%) | 2 |
| Nervous system disorders - Other, specify | 2/6 (33.3%) | 2 |
| Peripheral sensory neuropathy | 2/6 (33.3%) | 2 |
| Psychiatric disorders | ||
| Confusion | 2/6 (33.3%) | 2 |
| Depression | 1/6 (16.7%) | 4 |
| Insomnia | 2/6 (33.3%) | 3 |
| Renal and urinary disorders | ||
| Acute kidney injury | 1/6 (16.7%) | 1 |
| Chronic kidney disease | 1/6 (16.7%) | 1 |
| Hematuria | 1/6 (16.7%) | 1 |
| Urinary incontinence | 1/6 (16.7%) | 1 |
| Reproductive system and breast disorders | ||
| Genital edema | 1/6 (16.7%) | 1 |
| Reproductive system and breast disorders - Other, specify | 1/6 (16.7%) | 1 |
| Scrotal pain | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| Allergic rhinitis | 1/6 (16.7%) | 1 |
| Apnea | 1/6 (16.7%) | 2 |
| Atelectasis | 2/6 (33.3%) | 4 |
| Cough | 2/6 (33.3%) | 4 |
| Dyspnea | 5/6 (83.3%) | 8 |
| Hypoxia | 1/6 (16.7%) | 1 |
| Pleural effusion | 2/6 (33.3%) | 5 |
| Productive cough | 1/6 (16.7%) | 1 |
| Respiratory failure | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders - Other, specify | 2/6 (33.3%) | 4 |
| Sleep apnea | 1/6 (16.7%) | 1 |
| Sore throat | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Dry skin | 2/6 (33.3%) | 3 |
| Erythema multiforme | 2/6 (33.3%) | 2 |
| Pruritus | 2/6 (33.3%) | 2 |
| Rash maculo-papular | 4/6 (66.7%) | 5 |
| Skin and subcutaneous tissue disorders - Other, specify | 2/6 (33.3%) | 2 |
| Skin hyperpigmentation | 2/6 (33.3%) | 2 |
| Skin ulceration | 1/6 (16.7%) | 1 |
| Surgical and medical procedures | ||
| Surgical and medical procedures - Other, specify | 1/6 (16.7%) | 1 |
| Vascular disorders | ||
| Hematoma | 1/6 (16.7%) | 1 |
| Hypertension | 4/6 (66.7%) | 9 |
| Hypotension | 4/6 (66.7%) | 6 |
| Thromboembolic event | 1/6 (16.7%) | 1 |
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 | Asad Bashey, MD, PhD |
|---|---|
| Organization | Blood and Marrow Transplant Group of Georgia |
| Phone | |
| abashey@bmtga.com |
- CALGB-100601
- CALGB-100601
- CDR0000667954