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This study is a phase I/II study to determine the safety and efficacy of AMD3100 when combined with mitoxantrone, etoposide, and cytarabine in patients with relapsed or refractory AML.
We hypothesize that disrupting the interaction between AML blasts and the marrow microenvironment with AMD3100 may enhance the cytotoxic effect of chemotherapy.
The interaction of leukemic blasts with the bone marrow microenvironment is postulated to be an important mediator of chemoresistance in AML. Although a number of receptor / ligand pairs have been implicated, the CXCR4 / SDF-1 axis functions as the principal regulator of homing and retention of both normal and malignant hematopoietic cells in the marrow. AMD3100 is a bicyclam molecule which reversibly blocks CXCR4 binding to SDF-1 and is being developed clinically as a mobilization agent for hematopoietic stem cell transplantation. Preclinical data from our group has demonstrated that in murine models, plerixafor can disrupt the interaction of leukemic cells with the marrow microenvironment and sensitize blasts to the effect of chemotherapy. Based on these data, we have initiated a phase I/II study in patients with relapsed or refractory AML in which plerixafor is administered prior to salvage chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I Dose Escalation | Experimental |
Dose Level 1 AMD3100 dose = 80 mcg/kg/d Dose Level 2 AMD3100 dose = 160 mcg/kg/d |
|
| Phase II Dose Treatment | Experimental |
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMD3100 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML | A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity. | Completion of all patients in Phase I portion (232 days) |
| Phase II Only: Complete Response Rate of AMD3100 + MEC | Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response. Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi). | 42 days |
| Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of AMD3100 + MEC. | Treatment related mortality (deaths occurring during treatment) | 42 days |
| Time to Neutrophil Recovery | Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3. |
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Inclusion Criteria:
Acute myeloid leukemia diagnosed by WHO criteria with one of the following:
Age between 18 and 70 years of age
Adequate organ function defined as Creatinine <= 1.5 x institutional ULN; AST, ALT, total bilirubin <= 2 x ULN; Left ventricular ejection fraction of >= 40% by MUGA scan
Women of childbearing potential and sexually active males must be willing and able to use effective contraception while on study
Able to provide signed informed consent prior to registration on study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geoffrey L. Uy, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22308295 | Derived | Uy GL, Rettig MP, Motabi IH, McFarland K, Trinkaus KM, Hladnik LM, Kulkarni S, Abboud CN, Cashen AF, Stockerl-Goldstein KE, Vij R, Westervelt P, DiPersio JF. A phase 1/2 study of chemosensitization with the CXCR4 antagonist plerixafor in relapsed or refractory acute myeloid leukemia. Blood. 2012 Apr 26;119(17):3917-24. doi: 10.1182/blood-2011-10-383406. Epub 2012 Feb 2. |
| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Recruitment occurred from 07/12/2007 until 01/14/2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I Dose Escalation (Dose Level 1) |
Dose Level 1 AMD3100 dose = 80 mcg/kg/d |
| FG001 | Phase I Dose Escalation (Dose Level 2) |
Dose Level 2 AMD3100 dose = 160 mcg/kg/d |
| FG002 | Phase II Dose Treatment (Dose Level 3) |
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose). The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I Dose Escalation (Dose Level 1) |
Dose Level 1 AMD3100 dose = 80 mcg/kg/d |
| BG001 | Phase I Dose Escalation (Dose Level 2) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phase I Only: Optimal Dose of AMD3100 Plus MEC in Patients With Relapsed or Refractory AML | A standard 3+3 design was used in the Phase I portion starting with the AMD3100 dose of 80 mcg/kg and escalating by 80 mcg/kg for each successive cohort up to a maximum of 240 mcg/kg/d. The optimal dose was defined as the highest dose of AMD3100 <= 240 mcg/kg at which 0-1 of 6 patients experienced a dose limiting toxicity. | The Phase I Dose Escalation portion included (3) patients enrolled in Dose Level 1 and (3) patients enrolled in Dose Level 2. The (6) patients enrolled in Dose Level 3 that determined the Phase II dose are included in the population for this outcome. | Posted | Number | mcg/kg | Completion of all patients in Phase I portion (232 days) |
|
Adverse event assessment was collected from start of treatment for 42 days
The adverse events are not split into Phase I Dose Escalation portion and the Phase II Dose Treatment portion instead all events are reported as a whole.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase I Dose Escalation (Dose Level 1) |
Dose Level 1 AMD3100 dose = 80 mcg/kg/d |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction - platelet transfusion | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Grade 5 - unlikely related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ALT | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Geoffrey L. Uy, M.D. | Washington University School of Medicine | 314-454-8304 | guy@dom.wustl.edu |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| C061400 | etoposide phosphate |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Mitoxantrone |
| Drug |
|
|
| Etoposide | Drug |
|
|
| Cytarabine | Drug |
|
|
| 42 days |
| Time to Platelet Recovery | Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions. | 42 days |
| Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I) | Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0. Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC. | Day 0 |
| Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I) | Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0. | Day 0 |
| Pharmacokinetics of AMD3100 on MEC | Day 1 - Phase 2 only |
| Time to Progression | Every 6 months |
| Treatment Failure | Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi. | 42 days |
| Overall Survival | 1 year |
| Relapse-free Survival | This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause. Kaplain-Meier estimate was used. | 1 year |
| Death |
|
Dose Level 2 AMD3100 dose = 160 mcg/kg/d
| BG002 | Phase II Dose Treatment (Dose Level 3) |
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose). The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Acute myeloid leukemia (AML) source | MDS = myelodysplastic syndrome MPD = myeloproliferative disease | Number | participants |
|
| Prior transplantation | Number | participants |
|
| Eastern Cooperative Oncology Group (ECOG) Performance Status | Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 Fully active able to carry on all predisease performance without restriction
| Number | participants |
|
| Treatment Indication | Number | participants |
|
|
|
| Primary | Phase II Only: Complete Response Rate of AMD3100 + MEC | Responses were assessed according to the International Working Group Criteria for AML. All patients who received at least one dose of AMD3100 were considered evaluable for response. Response rate was the rate of complete remission plus complete remission with incomplete blood count recovery (CR + CRi). | Posted | Number | percentage of participants | 42 days |
|
|
|
| Primary | Ability of AMD3100 + MEC to Induce dsDNA Damage and Apoptosis in Leukemic Blasts From Bone Marrow or Peripheral Blood Fractions | This outcome was not analyzed as data was not collected. | Posted | 42 days |
|
|
| Secondary | Safety and Tolerability of AMD3100 + MEC. | Treatment related mortality (deaths occurring during treatment) | The 46 patients include the 6 patients treated on Dose Level 3 of the Phase I portion of the study. | Posted | Number | participants | 42 days |
|
|
|
| Secondary | Time to Neutrophil Recovery | Defined as the date of the first dose of AMD3100 to the date that the absolute neutrophil count >1,000 cells/mm^3. | This analysis includes patients who achieved a CR or a CRi. | Posted | Median | Full Range | days | 42 days |
|
|
|
| Secondary | Time to Platelet Recovery | Defined as the date of the first dose of AMD3100 to the date that the platelet count is >100,000/mm3 in the absence of platelet transfusions. | This analysis includes patients who achieved a CR. | Posted | Median | Full Range | days | 42 days |
|
|
|
| Secondary | Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of Total Leukocytes (Phase I) | Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0. Characterization of the mobilized cells as well as the kinetics of mobilization will be determined by analyzing the surface expression of mobilized cells by flow cytometry at the specified time points in conjunction with their total leukocyte count from the patient's CBC. | Posted | Median | Full Range | cells x 10^3/microliter | Day 0 |
|
|
|
| Secondary | Characterize the Mobilization of Leukemic Cells With AMD3100 by Measuring the Peak Mobilization of AML Blasts (Phase I) | Measured at 0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 24 hours after AMD3100 dose on Day 0. | Posted | Median | Full Range | percentage of AML blasts | Day 0 |
|
|
|
| Secondary | Pharmacokinetics of AMD3100 on MEC | This was not performed. | Posted | Day 1 - Phase 2 only |
|
|
| Secondary | Time to Progression | This outcome was not analyzed instead "reason for treatment failure" was analyzed as it provided better information on why the treatment did not work. | Posted | Every 6 months |
|
|
| Secondary | Treatment Failure | Treatment failures includes those patients for whom treatment has failed to achieve a CR or a CRi. | Posted | Number | participants | 42 days |
|
|
|
| Secondary | Overall Survival | Posted | Number | percentage of participants | 1 year |
|
|
|
| Secondary | Relapse-free Survival | This is determined only for patients achieving a complete remission. Defined as the interval from the date of the first documentation of a leukemia free state to date of recurrence or death due to any cause. Kaplain-Meier estimate was used. | This excludes the 25 participants who had treatment failure. | Posted | Number | percentage of participants | 1 year |
|
|
|
| 0 |
| 3 |
| 3 |
| 3 |
| EG001 | Phase I Dose Escalation (Dose Level 2) |
Dose Level 2 AMD3100 dose = 160 mcg/kg/d | 0 | 3 | 3 | 3 |
| EG002 | Phase II Dose Treatment (Dose Level 3) |
Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose). The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose. | 3 | 46 | 46 | 46 |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Unrelated |
|
| Infection-other (gram negative sepsis) | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Grade 5 unrelated |
|
| AST | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal cramping | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Acute febrile neutrophilic dermatosis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Agitation | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alkaline phosphatase | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction - NOS | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction - general itching during transfusion | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Allergic reaction - platelet transfusion | Immune system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilateral extremity echymosis | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bilateral extremity petichiae | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bladder spasms | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Blurred vison | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bone marrow biopsy site pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bruising | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Bumps on legs and arms | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Catheter site insertion pain | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Chest pain | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Chills | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Claustrophobia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Coccyx pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cognitive disturbance - lethargy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Colitis, infectious - clostridium difficile | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Confusion | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diaphoresis | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema face | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema trunk | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Esophagus pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Extremity pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Facial pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fever | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized bone pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized edema | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized joint pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Generalized pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hematoma | General disorders | CTCAE (3.0) | Systematic Assessment | right arm and central line placement |
|
| Hemoglobin | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage - eye | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage - nose | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhoidal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hepatomegaly | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hip pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperbilirubinemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypernatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoalbuminemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypokalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypophosphatemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypothermia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incisional pain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Incontinence - secondary to urinary urgency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Indigestion | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection, gram positive cocci | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Injection site pain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Injection site reaction | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Itching (pruritus) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Jaundice - right eye | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Jaw pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Left arm pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Left elbow pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Left lower abdominal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Leukocytes | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Lip swelling | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Liver abcess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Lower back wound pain | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Lower extremity pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration (not specified) | Psychiatric disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mouth pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mouth pain - right side | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mucositis (oral and stomach) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness - generalized | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nasal/paranasal reactions - sinusitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy (not specified) | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - bilateral feet | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - bilateral hands | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - face | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - left eye droop | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - left hand | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - right ankle | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neuropathy - toes | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutrophils | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Opportunistic infection (pneumonia NOS) | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Opportunistic infection - urinary tract | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Opportunistic infection, nasal | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pain upon inspiration | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Perianal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Perirectal abscess | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Petichiae | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pilonidal cyst | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Includes undefined rash, vaginal, lower extremities, left arm, and bilateral arms. |
|
| Red and swollen left labia | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Restless leg syndrome | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Rib pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right arm pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right ear pain | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right forearm pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right head and neck pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right hip pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right jaw pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right side pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Right upper quadrant pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sinus pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tachypnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Throat pain | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | CTCAE (3.0) | Systematic Assessment |
|
| Tooth pain | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ulceration | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary hesitancy | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vaginal bleeding | Pregnancy, puerperium and perinatal conditions | CTCAE (3.0) | Systematic Assessment |
|
| Vasovagal episode | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vision - floaters | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Visual changes | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Wound - coccyx | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Weakness | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection - gram negative sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection - gram negative bacilli | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| CR only |
|
|
| Total leukocytes at 2 hours |
|
| Total leukocytes at 4 hours |
|
| Total leukocytes at 6 hours |
|
| Total leukocytes at 8 hours |
|
| Total leukocytes at 12 hours |
|
| Total leukocytes at 24 hours |
|
| AML blasts at 1 hour |
|
| AML blasts at 2 hours |
|
| AML blasts at 4 hours |
|
| AML blasts at 6 hours |
|
| AML blasts at 8 hours |
|
| AML blasts at 12 hours |
|
| AML blasts at 24 hours |
|
| Death during aplasia |
|
| Unknown |
|