Trial · NCT03912064
A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
NCT03912064, Phase 1, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2026-01-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT. Trials, record NCT03912064. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03912064
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 1 Trial of CD25/Treg-depleted DLI Plus Ipilimumab for Myeloid Disease Relapse After Matched-HCT
- NCT number
- NCT03912064
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 25 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Myelofibrosis
- Interventions
- Ipilimumab, CD25hi Treg depleted DLI
- First posted
- 2019-04-11
- Last updated
- 2026-01-05
- Results first posted
- 2026-01-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) for DLI | Day 43 (6 weeks) | The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol. |
| Primary | Maximum Tolerated Dose (MTD) for Ipilimumab | Day 43 (6 weeks) | The primary objective of this study is to determine the safety (MTD) of CD25/Treg-depleted donor lymphocyte infusion (DLI) plus Ipilimumab in patients with myeloid relapse after matched-HCT. Participants will be evaluated for dose limiting toxicities (DLTs) at day 43. DLTs explained within section 5.4 of the protocol. |
| Secondary | Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi) | Day 43 (6 weeks) | Complete remission will be evaluated for each disease, along with duration of complete remission. AML morphological complete remission can be found in Appendix E (E.1.1.), and Relapse from CR/CRi is in E.1.3. MDS/MPN complete remission criteria is found in Appendix F (F.1.1), and criteria for relapse is found in F.1.5. |
| Secondary | Progression Free Survival | Day 92 and Week 60 | Duration of time from start of treatment to time of objective disease progression or death, whichever comes first. AML progressive disease is defined in Appendix E (E.1.7.), and criteria for MDS/MPN is in Appendix F (F.1.4.). |
| Secondary | Overall Survival | Day 92 and Week 60 | Duration of time from start of treatment to time of death. |
| Secondary | Incidence of Acute GVHD Rates | Day 92 | Incidence of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C. |
| Secondary | Incidence of Chronic GVHD Rates | Day 92 | Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92. |
| Secondary | Severity of Acute GVHD Rates | Day 92 | Severity of aGVHD will be measured at the below time point, and grading severity of aGVHD will be standardized using the chart and information in Appendix C per Harris et al, 2016 "GVHD Target Organ Staging", where 0 is no GVHD and 4 is severe. For the data table below: Grade I-IV reports any incidence of aGVHD, Grade II-IV reports the number of subjects who developed grade II, III, and IV aGVHD and Grade III-IV reports the number of subjects who developed Grade III and IV aGHVD. Grade 0: No stage 1-4 of any organ. Grade I: Stage 1-2 skin without liver, upper GI, or lower GI involvement. Grade II: Stage 3 rash and/or stage 1 liver and/or stage 1 upper GI and/or stage 1 lower GI. Grade III: Stage 2-3 liver and/or stage 2-3 lower GI, with stage 0-3 skin and/or stage 0-1 upper GI. Grade IV: Stage 4 skin, liver, or lower GI involvement, with stage 0-1 upper GI. |
| Secondary | Severity of Chronic GVHD Rates | Day 92 | Provider will assess study subject for severity of cGVHD per 2014 NIH consensus criteria at day 92. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) for DLI | Day 43 (6 weeks) | cells/kg | NUMBER | |
| PRIMARY | Maximum Tolerated Dose (MTD) for Ipilimumab | Day 43 (6 weeks) | mg/kg | NUMBER | |
| SECONDARY | Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi) | Day 43 (6 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression Free Survival | Day 92 and Week 60 | percentage of participants | NUMBER | |
| SECONDARY | Overall Survival | Day 92 and Week 60 | percentage of participants | NUMBER | |
| SECONDARY | Incidence of Acute GVHD Rates | Day 92 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Incidence of Chronic GVHD Rates | Day 92 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Acute GVHD Rates | Day 92 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Severity of Chronic GVHD Rates | Day 92 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group41
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) for DLI | CD25/Treg-depleted DLI | 30000000 | cells/kg | ||
| Maximum Tolerated Dose (MTD) for Ipilimumab | Ipilimumab | 1 | mg/kg | ||
| Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi) | Dose Level: 0 | 8 | Participants | ||
| Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi) | Dose Level: 1 | 4 | Participants | ||
| Response Rate as Determined by Complete Remission (CR) and CR With Incomplete Count Recovery (CRi) | Dose Level: 2 | 0 | Participants | ||
| Progression Free Survival | Dose Level: 0 | Day 92 | 50 | 95% Confidence Interval 27 to 73 | percentage of participants |
| Progression Free Survival | Dose Level: 1 | Day 92 | 83 | 95% Confidence Interval 53 to 100 | percentage of participants |
| Progression Free Survival | Dose Level: 2 | Day 92 | NA | 95% Confidence Interval NA to NA | percentage of participants |
| Progression Free Survival | Dose Level: 0 | Week 60 | 33 | 95% Confidence Interval 11 to 55 | percentage of participants |
| Progression Free Survival | Dose Level: 1 | Week 60 | 17 | 95% Confidence Interval 0 to 47 | percentage of participants |
1 to 10 of 41Source ClinicalTrials.gov
See all 41 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dose Level: 0 | 18 | |
| Overall Study | STARTED | Dose Level: 1 | 6 | |
| Overall Study | STARTED | Dose Level: 2 | 1 | |
| Overall Study | COMPLETED | Dose Level: 0 | 1 | |
| Overall Study | COMPLETED | Dose Level: 1 | 0 | |
| Overall Study | COMPLETED | Dose Level: 2 | 0 | |
| Overall Study | NOT COMPLETED | Dose Level: 0 | 17 | |
| Overall Study | NOT COMPLETED | Dose Level: 1 | 6 | |
| Overall Study | NOT COMPLETED | Dose Level: 2 | 1 |
Source ClinicalTrials.gov
Adverse events342
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 |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Dose Level: 0 | 10 | 18 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level: 1 | 1 | 6 | |
| other | Anemia | Blood and lymphatic system disorders | Dose Level: 2 | 0 | 1 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Dose Level: 0 | 1 | 18 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Dose Level: 1 | 0 | 6 | |
| other | Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | Dose Level: 2 | 0 | 1 | |
| other | Sinus tachycardia | Cardiac disorders | Dose Level: 0 | 1 | 18 | |
| other | Sinus tachycardia | Cardiac disorders | Dose Level: 1 | 0 | 6 | |
| other | Sinus tachycardia | Cardiac disorders | Dose Level: 2 | 0 | 1 | |
| other | Ear pain | Ear and labyrinth disorders | Dose Level: 0 | 1 | 18 |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Level: 0 | 7 | 18 |
| Total, all-cause mortality | Dose Level: 1 | 2 | 6 |
| Total, all-cause mortality | Dose Level: 2 | 1 | 1 |
| Total, other adverse events | Dose Level: 0 | 18 | 18 |
| Total, other adverse events | Dose Level: 1 | 6 | 6 |
| Total, other adverse events | Dose Level: 2 | 1 | 1 |
| Total, serious adverse events | Dose Level: 0 | 4 | 18 |
| Total, serious adverse events | Dose Level: 1 | 2 | 6 |
| Total, serious adverse events | Dose Level: 2 | 1 | 1 |
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 |
|---|---|---|---|---|---|
| P01CA229092 | Immune Modulation After Allogeneic HCT | SOIFFER, ROBERT JON | DANA-FARBER CANCER INST | NATIONAL CANCER INSTITUTE | 2019 to 2023 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03912064
GET https://conductscience.org/api/trials/v1/NCT03912064/results?page=2