Trial · NCT02756572
Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
NCT02756572, Phase 2, Completed, University of Washington; results first posted 2021-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms. Trials, record NCT02756572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02756572
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Allogeneic Hematopoietic Cell Transplantation in Treating Patients With Relapsed or Refractory High-Grade Myeloid Neoplasms
- NCT number
- NCT02756572
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- University of Washington
- Conditions
Blasts 10 Percent or More of Bone Marrow Nucleated Cells, Chronic Myelomonocytic Leukemia-2, High Grade Malignant Neoplasm, Myelodysplastic Syndrome, Myelodysplastic Syndrome With Excess Blasts-2, Myeloid Neoplasm, Previously Treated Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Interventions
Cladribine, Cyclosporine, Cytarabine, Filgrastim, Fludarabine Phosphate, Allogeneic Hematopoietic Stem Cell Transplantation, Laboratory Biomarker Analysis, Melphalan, Mitoxantrone Hydrochloride, Mycophenolate Mofetil, Questionnaire Administration, Sirolimus, Total-Body Irradiation, Melphalan Hydrochloride
- First posted
- 2016-04-29
- Last updated
- 2021-11-08
- Results first posted
- 2021-03-22
- Limitations and caveats
Some patients did not move on with transplant on study within 60 days of chemotherapy due to issues with scheduling pre-transplant evaluations, donor searches, and donor availability which caused delays. Some patients were also taken off this study to enroll onto other, more appropriate transplant clinical trials.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant | Up to 60 days after start of chemotherapy | Success will be defined as enrollment of at least 30 patients with transplants occurring in 15 of these 30 (50%) within 60 days of enrollment or start of induction chemotherapy with G-CLAM, whichever is earlier. |
| Primary | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant | 6 months after early allogeneic HCT on study | Success will be defined as observing a 40% of higher 6-month relapse-free survival among patients who received early transplant on study. |
| Secondary | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Approximately 28 days after early allogeneic HCT | Complete Remission (CR), defined as \<5% blasts in bone marrow with hematologic recovery (ANC\>1000/ul and platelets \>100,000/ml). CRi, defined as complete remission with insufficient hematologic recovery (ANC\<1000/ul or platelets\<100,000/ul). CRp, defined as complete remission but platelets \<100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria. Morphologic leukemia-free state (MLFS), defined as \<5% blasts in bone marrow with no hematologic recovery. Relapse, defined as \>5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease. |
| Secondary | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84 | Approximately 84 days after early allogeneic HCT | Complete Remission (CR), defined as \<5% blasts in bone marrow with hematologic recovery (ANC\>1000/ul and platelets \>100,000/ml). CRi, defined as complete remission with insufficient hematologic recovery (ANC\<1000/ul or platelets\<100,000/ul). CRp, defined as complete remission but platelets \<100,000/ul. Minimal residual disease (MRD), defined as any detectable disease by flow cytometry, cytogenetics, FISH or PCR in a patient otherwise fulfilling remission criteria. Morphologic leukemia-free state (MLFS), defined as \<5% blasts in bone marrow with no hematologic recovery. Relapse, defined as \>5% blasts in bone marrow, flow cytometry, or manual differential; OR treatment for active relapsed disease. |
| Secondary | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant | Up to 100 days post-transplant | Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. |
| Secondary | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant | Up to 6 months post-transplant | Relapse-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. |
| Secondary | Event-free Survival (EFS) Among Patients Who Received Early Transplant | Up to 100 days post-transplant | Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. |
| Secondary | Event-free Survival (EFS) Among Patients Who Received Early Transplant | Up to 6 months post-transplant | Event-free survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. Events included death, relapse, and grade 3-4 acute graft vs host disease. |
| Secondary | Overall Survival (OS) Among Patients Who Received Early Transplant. | Up to 100 days post-transplant | Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. |
| Secondary | Overall Survival (OS) Among Patients Who Received Early Transplant. | Up to 6 months post-transplant | Overall survival among patients who received early allogeneic HCT on study as estimated with the Kaplan-Meier method. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant | Up to 60 days after start of chemotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant | 6 months after early allogeneic HCT on study | Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not including in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Approximately 28 days after early allogeneic HCT | Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not including in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 84 | Approximately 84 days after early allogeneic HCT | Nine subjects received allogeneic HCT on study, however one subject died shortly after HCT and was not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant | Up to 100 days post-transplant | Percentage of participants | NUMBER | |
| SECONDARY | Relapse-free Survival (RFS) Among Patients Who Received Early Transplant | Up to 6 months post-transplant | Percentage of participants | NUMBER | |
| SECONDARY | Event-free Survival (EFS) Among Patients Who Received Early Transplant | Up to 100 days post-transplant | Percentage of participants | NUMBER | |
| SECONDARY | Event-free Survival (EFS) Among Patients Who Received Early Transplant | Up to 6 months post-transplant | Percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) Among Patients Who Received Early Transplant. | Up to 100 days post-transplant | Percentage of participants | NUMBER | |
| SECONDARY | Overall Survival (OS) Among Patients Who Received Early Transplant. | Up to 6 months post-transplant | Percentage of participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant | Treatment (Chemotherapy, HCT) | Received allogeneic HCT on study within 60 days (feasibility success) | 9 | Participants | |
| Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Enrollment and Incidence of Early Transplant | Treatment (Chemotherapy, HCT) | Did not receive allogeneic HCT on study within 60 days (feasibility failure) | 21 | Participants | |
| Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant | Received Early Allogeneic HCT on Study | No relapse within 6 months post-HCT (feasibility success) | 6 | Participants | |
| Feasibility of Early Allogeneic Hematopoietic Cell Transplant Assessed by Relapsed-free Survival 6 Months After Transplant | Received Early Allogeneic HCT on Study | Relapse within 6 months post-HCT (feasibility failure) | 2 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | CR with MRD | 0 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | CR without MRD | 7 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | CRi with MRD | 0 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | CRi without MRD | 1 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | MLFS with MRD | 0 | Participants | |
| Response Assessments After Early Allogeneic Hematopoietic Cell Transplant, Day 28 | Received Allogeneic HCT on Study | MLFS without MRD | 0 | Participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Chemotherapy, HCT) | 30 | |
| Overall Study | COMPLETED | Treatment (Chemotherapy, HCT) | 30 | |
| Overall Study | NOT COMPLETED | Treatment (Chemotherapy, HCT) | 0 |
Source ClinicalTrials.gov
Adverse events116
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Headache | Nervous system disorders | Post-Chemotherapy | 3 | 30 | 3 |
| serious | Headache | Nervous system disorders | Post-Transplant | 0 | 9 | 0 |
| serious | Intracranial lesions | Nervous system disorders | Post-Chemotherapy | 1 | 30 | 1 |
| serious | Intracranial lesions | Nervous system disorders | Post-Transplant | 0 | 9 | 0 |
| serious | Syncope | Nervous system disorders | Post-Chemotherapy | 2 | 30 | 2 |
| serious | Syncope | Nervous system disorders | Post-Transplant | 0 | 9 | 0 |
| serious | Stroke | Nervous system disorders | Post-Chemotherapy | 1 | 30 | 1 |
| serious | Stroke | Nervous system disorders | Post-Transplant | 0 | 9 | 0 |
| serious | Encephalopathy | Nervous system disorders | Post-Chemotherapy | 1 | 30 | 1 |
| serious | Encephalopathy | Nervous system disorders | Post-Transplant | 0 | 9 | 0 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Post-Chemotherapy | 5 | 30 |
| Total, all-cause mortality | Post-Transplant | 2 | 9 |
| Total, other adverse events | Post-Chemotherapy | 0 | 0 |
| Total, other adverse events | Post-Transplant | 0 | 0 |
| Total, serious adverse events | Post-Chemotherapy | 30 | 30 |
| Total, serious adverse events | Post-Transplant | 9 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Post-Chemotherapy vs Post-Transplant: deaths from any cause | Trial comparisons |
| Post-Chemotherapy vs Post-Transplant: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02756572
GET https://conductscience.org/api/trials/v1/NCT02756572/results?page=2