Leukemia Stem Cell Detection in Acute Myeloid Leukemia
Study Details
Study Description
Brief Summary
Most patients with acute myeloid leukemia (AML) achieve complete remission (CR) following induction chemotherapy. However, a large majority subsequently relapse and succumb to the disease. Currently, cytogenetics and molecular aberrations are the best prognostic indicators; however, these factors cannot prognosticate accurately for individual patients. Overall, the majority of patients with favorable or intermediate-risk AML will experience relapse. Prognosis after relapse is dismal with a five-year overall survival rate of less than 10%. A leukemia stem cell (LSC) paradigm may explain this failure of CR to reliably translate into cure. This study is undertaken to determine whether the presence of LSCs has prognostic value as well as to determine whether the presence of LSCs has predictive value. This study has an observational component, whereby we intent evaluate whether the presence or absence of LSCs is prognostic. This study also has an interventional component in which it uses LSC status to determine whether favorable and intermediate risk AML patients in CR receive consolidation with chemotherapy or allogeneic HCT.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Evaluable Cohort - Transplant Arm Other - Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT |
Procedure: Allogeneic HCT
Allogeneic HCT
Other Names:
|
| Other: Evaluable Cohort - Consolidation Chemo Arm Other - Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) |
Drug: Consolidation chemotherapy
Cytarabine-based consolidation chemotherapy
Other Names:
|
| No Intervention: Observational Cohort 1 Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1. |
|
| No Intervention: Observational Cohort 2 Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: Lack the immunophenotype of interest, Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT. |
Outcome Measures
Primary Outcome Measures
- 2 Year Relapse Free Survival (RFS) [2 years]
Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Must have previously signed the specimen procurement protocol consent associated with the leukemia stem cell assay ("Step 1 informed consent") prior to starting AML therapy.
-
Age 18 years and older
-
New diagnosis of AML, other than APL, confirmed by bone marrow aspirate/biopsy and reviewed by an institutional hematopathologist
-
Completion of induction therapy, as defined by the Investigator and post-induction bone marrow biopsy.
Exclusion Criteria:
-
Any debilitating medical or psychiatric illness that would preclude ability to follow study procedures.
-
Indeterminate leukemia stem cell assay results at diagnosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Michael Grunwald, M.D., Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
None provided.- LCI-HEM-AML-SCD-001
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 |
|---|---|---|---|---|
| Arm/Group Description | Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT Allogeneic HCT | Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy | Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1. | Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: Lack the immunophenotype of interest, Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT. |
| Period Title: Overall Study | ||||
| STARTED | 1 | 6 | 4 | 7 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 6 | 4 | 7 |
Baseline Characteristics
| Arm/Group Title | Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy | Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy | Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1. | Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: Lack the immunophenotype of interest, Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT. | Total of all reporting groups |
| Overall Participants | 1 | 6 | 4 | 7 | 18 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
1
100%
|
5
83.3%
|
4
100%
|
6
85.7%
|
16
88.9%
|
| >=65 years |
0
0%
|
1
16.7%
|
0
0%
|
1
14.3%
|
2
11.1%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
35.0
(NA)
|
44.3
(14.7)
|
51.0
(14.5)
|
46.3
(15.6)
|
46.1
(14.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
0
0%
|
2
33.3%
|
2
50%
|
4
57.1%
|
8
44.4%
|
| Male |
1
100%
|
4
66.7%
|
2
50%
|
3
42.9%
|
10
55.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
2
33.3%
|
3
75%
|
2
28.6%
|
7
38.9%
|
| White |
1
100%
|
4
66.7%
|
1
25%
|
4
57.1%
|
10
55.6%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
1
5.6%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| AML Risk Level (prior to induction) (Count of Participants) | |||||
| Favorable Risk |
0
0%
|
6
100%
|
1
25%
|
4
57.1%
|
11
61.1%
|
| Intermediate Risk |
0
0%
|
0
0%
|
2
50%
|
1
14.3%
|
3
16.7%
|
| Unfavorable Risk |
1
100%
|
0
0%
|
1
25%
|
2
28.6%
|
4
22.2%
|
| Immunophenotype at LSC0 (Count of Participants) | |||||
| CD34- |
0
0%
|
0
0%
|
1
25%
|
5
71.4%
|
6
33.3%
|
| CD34+CD38-ALDH(int) |
1
100%
|
6
100%
|
3
75%
|
1
14.3%
|
11
61.1%
|
| CD34+CD38-ALDH(high) |
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
1
5.6%
|
| LSC0 Status (prior to induction) (Count of Participants) | |||||
| Leukemia Stem Cells Detected |
1
100%
|
6
100%
|
3
75%
|
1
14.3%
|
11
61.1%
|
| Leukemia Stem Cells Not Detected |
0
0%
|
0
0%
|
1
25%
|
6
85.7%
|
7
38.9%
|
| Deletion 5 or 5q (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Deletion 7 or 7q (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| KNMT2A (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| inv(3) or t(3;3) (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
5
83.3%
|
4
100%
|
7
100%
|
17
94.4%
|
| Uninterpretable results |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
5.6%
|
| t(6;9) (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
5
83.3%
|
4
100%
|
7
100%
|
17
94.4%
|
| Uninterpretable results |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
5.6%
|
| t(9;22) (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
5
83.3%
|
4
100%
|
7
100%
|
17
94.4%
|
| Uninterpretable results |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
5.6%
|
| t(8;21) (Count of Participants) | |||||
| Positive |
0
0%
|
2
33.3%
|
0
0%
|
1
14.3%
|
3
16.7%
|
| Negative |
1
100%
|
4
66.7%
|
4
100%
|
6
85.7%
|
15
83.3%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| inv(16 or t(16;16) (Count of Participants) | |||||
| Positive |
0
0%
|
2
33.3%
|
0
0%
|
0
0%
|
2
11.1%
|
| Negative |
1
100%
|
4
66.7%
|
4
100%
|
7
100%
|
16
88.9%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Plus 8 (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
6
100%
|
4
100%
|
7
100%
|
18
100%
|
| Uninterpretable results |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Plus 21 (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
5
83.3%
|
4
100%
|
7
100%
|
17
94.4%
|
| Uninterpretable results |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
5.6%
|
| t(9;11) (Count of Participants) | |||||
| Positive |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Negative |
1
100%
|
5
83.3%
|
4
100%
|
7
100%
|
17
94.4%
|
| Uninterpretable results |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
5.6%
|
| LSC1 Status (post induction, at enrollment) (Count of Participants) | |||||
| Leukemia Stem Cells Detected |
0
0%
|
0
0%
|
1
25%
|
1
14.3%
|
2
11.1%
|
| Leukemia Stem Cells Not Detected |
0
0%
|
6
100%
|
2
50%
|
4
57.1%
|
12
66.7%
|
| Indeterminate/Unknown Results |
1
100%
|
0
0%
|
1
25%
|
2
28.6%
|
4
22.2%
|
Outcome Measures
| Title | 2 Year Relapse Free Survival (RFS) |
|---|---|
| Description | Comparison of 2 year RFS in patient with detectable LSCs in the marrow at the end of consolidation to the 2 year RFS of patients without detectable LSCs. IWG Criteria (Cheson 2003) was utilized to classify relapse, with relapse defined as ≥ 5% blasts in the marrow or peripheral blood, extramedullary disease, or disease presence determined by a physician upon clinical assessment. |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| The primary efficacy analyses will be conducted on the subset of subjects who were included in the evaluable cohort (HCT or chemo treatment arm) and who also had a successful/interpretable end of consolidation eLSC assay. This excludes subjects in OC1 and 2, as they did not achieve CR to induction or did not have the immunophenotype of interest. |
| Arm/Group Title | eLSC+ (Evaluable Cohort) | eLSC- (Evaluable Cohort) |
|---|---|---|
| Arm/Group Description | Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells detected post-consolidation. Note, eLSC indicates the time point after consolidation. | Of the subjects enrolled in the evaluable cohort (either allo HCT or consolidation chemotherapy), those who had leukemia stem cells not detected post-consolidation. Note, eLSC indicates the time point after consolidation. |
| Measure Participants | 0 | 5 |
| Count of Participants [Participants] |
NA
NaN
|
Adverse Events
| Time Frame | Graft Versus Host Disease (GVHD) events were collected from the time of consolidation HCT through long term follow-up (up to approximately 5 years). - Acute GVHD: Confirmed GVHD within 100 days of HCT. - Chronic GVHD: Confirmed GVHD 100 days or more after HCT. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Both cytarabine-based consolidation chemo and HCT are considered standard of care for this disease population. With the exception of GVHD, an event of clinical interest, adverse events experienced by the subjects were not recorded in the dataset or included in the safety analysis. Each occurrence of GVHD, in evaluable subjects who received HCT, was graded by the investigator according to accepted institutional practice: CIBMTR grading for Acute GVHD; NIH Consensus criteria for Chronic GVHD. | |||||||
| Arm/Group Title | Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 | ||||
| Arm/Group Description | Standard of Care Consolidation (HCT) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT); HMA-based induction subjects: Are candidates for (as determined by the investigator) and receive HCT Allogeneic HCT: Allogeneic HCT | Standard of Care Consolidation (cytarabine-based chemo) Enrolled subjects that will contribute to the population of subjects who are evaluable for the primary and secondary objectives. This will not include any subjects who end up in either observational cohort. To be included in the evaluable cohort, the subject must meet the following requirements: Complete remission (CR1) from standard cytarabine or HMA-based induction therapy per standard clinical criteria (Cheson Criteria) Have confirmed presence of CD34+CD38-ALDHint population by flow cytometry at the diagnostic LSC assay (LSC0) Cytarabine-based induction subjects: Are candidates for (as determined by the investigator) and receive consolidation therapy (cytarabine-based chemotherapy or HCT) Consolidation chemotherapy: Cytarabine-based consolidation chemotherapy | Enrolled subjects who do not achieve a CR to induction therapy, regardless of diagnostic phenotype. Following completion of induction therapy and remission bone marrow aspirate, if a subject is determined to not have achieved a complete remission to induction therapy, he or she would be included in observational cohort 1. | Enrolled subjects who achieve a CR to induction therapy but meet one or more of the following criteria: Lack the immunophenotype of interest, Cytarabine based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit or refusal)] and do not receive consolidation therapy (cytarabine-based chemotherapy or HCT) HMA-based induction subjects: Are not candidates for [as determined by the investigator (e.g. unfit, lack of donor, refusal)] and do not receive HCT Final investigator determination of fit-ness can occur at any time until the start of consolidation therapy. HMA-based induction subjects will not receive consolidation cytarabine-based chemotherapy as part of the evaluable cohort if they do not receive HCT. | ||||
All Cause Mortality |
||||||||
| Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 1/6 (16.7%) | 0/4 (0%) | 4/7 (57.1%) | ||||
Serious Adverse Events |
||||||||
| Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/6 (0%) | 0/4 (0%) | 0/7 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Evaluable Cohort - Transplant Arm | Evaluable Cohort - Consolidation Chemo Arm | Observational Cohort 1 | Observational Cohort 2 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/1 (0%) | 0/6 (0%) | 0/4 (0%) | 0/7 (0%) | ||||
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. James Symanowski; Chair, Department of Cancer Biostatistics |
|---|---|
| Organization | Levine Cancer Institute |
| Phone | 9804422371 |
| james.symanowski@atriumhealth.org |
- LCI-HEM-AML-SCD-001