Trial · NCT07015684
131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
NCT07015684, Phase 1, Recruiting, Columbia University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD). Trials, record NCT07015684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07015684
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 131I-apamistamab-based Conditioning for Hematopoietic Stem Cell Transplant (HSCT) in Advanced Sickle Cell Disease (SCD)
- NCT number
- NCT07015684
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Columbia University
- Conditions
- Sickling Disorder Due to Hemoglobin S
- Interventions
- 131I-apamistmab, Sirolimus, Campath, Total Body Irradiation, Exchange Transfusion, Planar gamma imaging
- First posted
- 2025-06-11
- Last updated
- 2026-06-10
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Graft failure rate | 42 days after blood stem cell (PB) transplantation | Graft failure defined as having had a primary or secondary graft failure by 42 days after blood stem cell (PB) transplantation. Primary graft failure is defined as failure to achieve an absolute neutrophil count (ANC) of \>500/ μL by 42 days after blood stem cell (PB) transplantation or a total donor chimerism of \>5%. Secondary graft failure is defined as cytopenias after initial engraftment (ANC \<500/μL) and a total donor cell chimerism decreasing to less than 5%. |
| Secondary | Event-free survival (EFS) Rate | Duration of study, up to 7 years | Event-free survival is defined as the time from treatment initiation to the occurrence of primary graft failure, death, Graft-versus-Host Disease (GVHD) Grade III-IV, whichever comes first. Patients without events will be censored at the time of last follow-up assessment. |
| Secondary | Time to engraftment of Neutrophils | Up to 7 years | Time to neutrophil engraftment is defined as the first of 3 measurements on consecutive days when the patient has an absolute neutrophil count of 500/μL after conditioning. |
| Secondary | Time to engraftment of Platelets | Up to 7 years | Time to platelet engraftment will be defined as the first day of a minimum of 3 measurements on different days that the patient has achieved a platelet count \> 50,000/μL AND did not receive a platelet transfusion in the previous 7 days. The exception is the case in which a subject is given a platelet transfusion specifically to achieve a platelet threshold to allow an elective invasive procedure, such as a central catheter removal. Time from treatment initiation to successful donor cell engraftment defined as having achieved \> 50% total Peripheral Blood Mononuclear Cells (PMC) donor cell chimerism upon successful engraftment at day +30 or upon meeting ANC and Plt engraftment whatever occurs first. |
| Secondary | Incidence of Graft-versus-Host Disease (GVHD) of any grade | Up to 7 years | Incidence of acute and chronic GVHD of any grade as evaluated according to The Center for International Blood and Marrow Transplant Research (CIBMTR) and National Institutes of Health (NIH) criteria respectively. |
| Secondary | Incidence of other transplant related toxicities | 12 Months Post Stem Cell Transplant | Incidence of other transplant related toxicities, including Veno-occlusive disease (VOD), Idiopathic pneumonia syndrome (IPS), Central nervous system (CNS) toxicity, or Posterior reversible encephalopathy syndrome (PRES). |
| Secondary | Incidence of significant transplant-related infections | 12 Months Post Stem Cell Transplant | Significant infections will be recorded including but not limited to bacterial or fungal sepsis, cytomegalovirus (CMV) reactivation with/without clinical disease, adenovirus infection, Epstein-Barr virus (EBV) reactivation with or without post-transplant lymphoproliferative disorder (PTLD), other significant viral reactivations or community-acquired viral infections and invasive mold infections. |
| Secondary | Number of participants with donor chimerism >5% | 100 days post-transplant and 1 year post transplant | Chimerism is a measure of the engraftment of donor cells within the recipient and is expressed as the percentage ratio between the number of donor cells and recipient cells. Chimerism will be determined by Short Tandem Repeat analysis. |
| Secondary | Percentage of Participants who Achieve Immune Reconstitution | 12 Months Post Stem Cell Transplant | Peripheral blood quantitative assessment of CD3+, CD4+, CD8+, CD19+, and CD16+/56+ lymphocytes will be assessed by flow cytometry. In addition, quantitative immunoglobulins will be measured for IgA, IgM and IgG. These will be performed at Day +60 (±10 days) as well as at 1 year (+/- 2 weeks) and after long term follow up at the discretion of the investigator. Descriptive statistics will be used to describe the percentage of patients who are able to achieve reconstitution of important lymphocyte subsets and B cell function at the defined timepoint above. |
| Secondary | Follicle-stimulating hormone (FSH) titer | At study inclusion and at 1 year post-transplant | To assess the impact of the conditioning on fertility, FSH titers will be measured. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
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/NCT07015684
GET https://conductscience.org/api/trials/v1/NCT07015684/registered