Last reviewed · How we verify
NCT03615144
TCR Alpha Beta T-cell and CD19 B-cell Depleted Peripheral Blood Stem Cell Transplantation Using the CliniMACS System for Patients With Non-Malignant Hematologic Disorders From Matched or Mismatched, Related or Unrelated Donors
Phase 2 trial testing Melphalan in Non-Malignant Hematologic Disorders in 1 participant. Terminated before completion.
13 November 2020
Quick facts
| Lead sponsor | Memorial Sloan Kettering Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 23 July 2018 |
| Primary completion | 13 November 2020 |
| Estimated completion | 13 November 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Melphalan (melphalan) — full drug profile →
- Thiotepa — full drug profile →
- Clofarabine (CLOFARABINE) — full drug profile →
- Fludarabine (FLUDARABINE) — full drug profile →
- Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®) — full drug profile →
- CliniMACS reagents
Conditions studied
- Non-Malignant Hematologic Disorders — all drugs for Non-Malignant Hematologic Disorders →
Sponsor
Memorial Sloan Kettering Cancer Center — full company profile →
Who can join
Adults 1 to 69, any sex, with Non-Malignant Hematologic Disorders. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (3 terms)
| Reaction | System | Melphalan/Thiotepa/Clofara… | Melphalan/Thiotepa/ Fludar… |
|---|---|---|---|
| Blood and lymphatic system disorders - Other, spec | Blood and lymphatic system disorders | — | — |
| Heart failure | Cardiac disorders | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — |
Most-reported serious reactions: Blood and lymphatic system disorders - Other, spec, Heart failure, Pulmonary hypertension.
Data from ClinicalTrials.gov NCT03615144 adverse events section.
Sponsor's own description
The purpose of this study is to find out if removing a specific type of white blood cell (called alpha beta T-cell) that help make up the transplant donor's stem cells can improve results of blood stem cell transplant for the participant's disease.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in <i>Ex Vivo</i> T Cell Depletion - Where Do We Stand?
Bryant AR, Perales MA. · · 2019 · cited 4× · PMID 31106295 · DOI 10.1002/acg2.29
Verify or expand the search:
- PubMed search for NCT03615144
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Melphalan
Trials testing the same drug.
- NCT06954987 — Venetoclax or Placebo in Combination With Reduced-Intensity Conditioning Hematopoietic Cell (Bone Marrow/Blood Stem Cell · Phase 2 · not yet recruiting
- NCT06996119 — Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versu · Phase 1 · not yet recruiting
- NCT07228624 — Ruxolitinib Before, During and After Hematopoietic Cell Transplant in Older Patients With Myelofibrosis and Myelodysplas · Phase 2 · recruiting
- NCT06287944 — 225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiati · Phase 1 · recruiting
- NCT06815003 — Vedolizumab Plus Post-transplant Cyclophosphamide and Short Course Tacrolimus for the Prevention of Graft Versus Host Di · Phase 2 · recruiting
Other Memorial Sloan Kettering Cancer Center trials
Trials by the same sponsor.
- NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting
- NCT07507643 — A Study of Methylprednisolone in People Having Liver Surgery · Phase 3 · recruiting
- NCT07483307 — A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer · Phase 2 · recruiting
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07449195 — A Study Comparing Two Optical Coherence Tomography Devices in People With Ocular Tumors · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03615144 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center
- Last refreshed: 24 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03615144.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing