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The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction chemotherapy followed by stem cell transplant | Experimental | Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ara-C | Drug | Induction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total) |
| Measure | Description | Time Frame |
|---|---|---|
| Response to Induction Chemotherapy (CR or PR) | Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made | Day 28-40 |
| Overall Survival | Up to 2000 days | |
| Relapse-free Survival | Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality. | Up to 2000 days |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Stem Cell Collection | Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg | 1-5 days from initiation of stem cell collection |
| Numbers of Stem Cells Collected |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Godley, M.D. | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Induction Chemotherapy Followed by Stem Cell Transplant | Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
|
| ||||||||||||||||||
| Enrollment |
| |||||||||||||||||||
| Induction Therapy |
| |||||||||||||||||||
| Stem Cell Mobilization |
| |||||||||||||||||||
| Autologous Transplant |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | Ara-C Mitoxantrone Etoposide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Response to Induction Chemotherapy (CR or PR) | Complete remission (CR): <5% bone marrow blasts with recovery of peripheral blood counts; complete cytogenetic remission, the disappearance of any pre-existing cytogenetic abnormality Partial remission (PR): >5% bone marrow blasts, but less than the pre-treatment blast percentage within the bone marrow Resistant disease (RD): no significant cytoreduction in bone marrow leukemic cells from pre-treatment levels Not evaluable (NE): patients who died during induction chemotherapy or who withdrew from follow-up before assessment could be made | Posted | Number | 95% Confidence Interval | percentage of participants | Day 28-40 |
|
2 months
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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 | All Patients | Ara-C Mitoxantrone Etoposide |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever | Infections and infestations | Systematic Assessment | Grade 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever | Infections and infestations | Systematic Assessment | Grade 3-4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lucy A. Godley | University of Chicago | 773-702-4140 | lgodley@medicine.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007951 | Leukemia, Myeloid |
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| ID | Term |
|---|---|
| D003561 | Cytarabine |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Mitoxantrone | Drug | Induction: 30mg/m2 after the end of HiDAC day 1 and day 5 |
|
| Etoposide | Drug | Mobilization: 30mg/kg over 6 doses given once every 12 hours for 3 days |
|
|
| 1-5 days from initiation of stem cell collection |
| Overall Survival in Patients Undergoing Autologous Stem Cell Transplant | Up to 817 days |
| Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant | Up to 883 days |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Overall Survival | Posted | Median | Inter-Quartile Range | Days | Up to 2000 days |
|
|
|
| Primary | Relapse-free Survival | Relapse is defined as bone marrow blasts >5% if the patient had achieved a complete remission, or the recurrence of any clonal cytogenetic abnormality. | Posted | Median | Inter-Quartile Range | Days | Up to 2000 days |
|
|
|
| Secondary | Feasibility of Stem Cell Collection | Feasibility is the ability to cryopreserve >=2.0 x 10^6 CD34+ cells/kg | Subset of patients in CR who underwent mobilization and attempted stem cell collection. | Posted | Number | 95% Confidence Interval | percentage of participants | 1-5 days from initiation of stem cell collection |
|
|
|
| Secondary | Numbers of Stem Cells Collected | Subset of patients in CR who underwent mobilization and attempted stem cell collection. | Posted | Median | Full Range | 10^6 CD34+ cells/kg | 1-5 days from initiation of stem cell collection |
|
|
|
| Secondary | Overall Survival in Patients Undergoing Autologous Stem Cell Transplant | Subset of patients undergoing autologous stem cell transplant | Posted | Median | Full Range | Days | Up to 817 days |
|
|
|
| Secondary | Disease-free Survival in Patients Undergoing Autologous Stem Cell Transplant | Subset of patients undergoing autologous stem cell transplant | Posted | Median | Full Range | Days | Up to 883 days |
|
|
|
| 7 |
| 32 |
| 31 |
| 32 |
| Infection with grade 4 neutrophils | Infections and infestations | Systematic Assessment |
|
| Hemorrhage | General disorders | Systematic Assessment | One intra cranial (grade 5) |
|
| Sudden death | General disorders | Non-systematic Assessment |
|
| Hemorrhage | Gastrointestinal disorders | Systematic Assessment | Grade 4 |
|
| Infection/sepsis | Infections and infestations | Systematic Assessment | Grade 3-4 |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment | Grade 3-4 |
|
| Left ventrcular dysfunction | Cardiac disorders | Systematic Assessment | Grade 3-4 |
|
| Non-infectious diarrhea | Gastrointestinal disorders | Systematic Assessment | Grade 3-4 |
|
| Anemia | General disorders | Systematic Assessment | Grade 3-4 |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hypotension | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Mental status changes | General disorders | Systematic Assessment |
|
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| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006571 |
| Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| 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 |