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| ID | Type | Description | Link |
|---|---|---|---|
| NA_00071844 | Other Identifier | JHMIRB |
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Low accrual
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The primary objective of the trial is to compare the two-year relapse-free survival (RFS) of patients with acute myeloid leukemia (AML), presumed to be at high risk for relapse due to the presence of leukemia stem cells (LSCs) in their bone marrow at first complete remission (CR1), who receive either standard cytarabine-based chemotherapy or allogeneic stem cell transplantation (SCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Leukemia Stem Cells - Consolidation | Experimental | Without LSC, standard cytarabine consolidation |
|
| Leukemia Stem Cells - Consolidation | Experimental | LSC present, randomized to cytarabine consolidation |
|
| Leukemia Stem Cells - Transplant | Experimental | LSC present, randomized to allogeneic transplant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytarabine consolidation | Drug | Cytarabine-based consolidation per institutional standards. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relapse Free Survival | Percentage of participants alive and without relapsed disease at two years. | 2 years |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Showel, MD | JHU | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Leukemia Stem Cells - Consolidation | Without LSC, standard cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. |
| FG001 | Leukemia Stem Cells - Consolidation | LSC present, randomized to cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. |
| FG002 | Leukemia Stem Cells - Transplant | LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Leukemia Stem Cells - Consolidation | Without LSC, standard cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. |
| BG001 | Leukemia Stem Cells - Consolidation |
| 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 | Relapse Free Survival | Percentage of participants alive and without relapsed disease at two years. | Posted | Number | percentage of participants | 2 years |
|
Collected monthly for up to 3.5 years.
Only unexpected adverse events, grades III-IV acute GVHD, and chronic GVHD were collected.
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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 | No Leukemia Stem Cells - Consolidation | Without LSC, standard cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Showel, MD | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 410-614-0675 | mshowel1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 18, 2017 | Jun 20, 2018 | Prot_SAP_000.pdf |
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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 |
|---|---|
| D014184 | Transplantation, Homologous |
| D016026 | Bone Marrow Transplantation |
| D033581 | Stem Cell Transplantation |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
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|
| Allogeneic transplant | Drug | Allogeneic stem cell transplant per institutional standards. |
|
|
LSC present, randomized to cytarabine consolidation
Cytarabine consolidation: Cytarabine-based consolidation per institutional standards.
| BG002 | Leukemia Stem Cells - Transplant | LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards. |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Leukemia Stem Cells - Consolidation | LSC present, randomized to cytarabine consolidation Cytarabine consolidation: Cytarabine-based consolidation per institutional standards. | 0 | 2 | 0 | 2 | 0 | 2 |
| EG002 | Leukemia Stem Cells - Transplant | LSC present, randomized to allogeneic transplant Allogeneic transplant: Allogeneic stem cell transplant per institutional standards. | 1 | 6 | 0 | 6 | 0 | 6 |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D017690 | Cell Transplantation |