Clinical trial · Interventional
Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
NCT02193880CI-TRIAL-00038326ABDcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft-Versus-Host Disease | — | UNRESOLVED | — |
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Alpha-beta depleted T-cell infusion
- description
- Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
- interventionNames
- Device: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
Primary outcomes (2)
- measure
- Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
- timeFrame
- From baseline and before day +100 of transplant.
- description
- Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
- measure
- Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
- timeFrame
- From baseline and before day +100 of transplant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Neoplastic hematological disorder with indication of allogeneic transplant * No available suitable HLA-matched donor * Adequate cardiac, pulmonary, renal, and hepatic function * Karnofsky performance status score greater than or equal to 70% Exclusion Criteria: * Medication non-compliance * No appropriate caregiver identified * Uncontrolled medical or psychiatric disorder * Active central nervous system (CNS) neoplastic involvement * Known allergy to Dimethyl Sulfoxide * HIV1 or HIV2 positive * Pregnant or breastfeeding
References
Publications (35)
- BACKGROUNDLee SJ, Klein J, Haagenson M, Baxter-Lowe LA, Confer DL, Eapen M, Fernandez-Vina M, Flomenberg N, Horowitz M, Hurley CK, Noreen H, Oudshoorn M, Petersdorf E, Setterholm M, Spellman S, Weisdorf D, Williams TM, Anasetti C. High-resolution donor-recipient HLA matching contributes to the success of unrelated donor marrow transplantation. Blood. 2007 Dec 15;110(13):4576-83. doi: 10.1182/blood-2007-06-097386. Epub 2007 Sep 4. PMID 17785583
- BACKGROUNDAlshemmari S, Ameen R, Gaziev J. Haploidentical hematopoietic stem-cell transplantation in adults. Bone Marrow Res. 2011;2011:303487. doi: 10.1155/2011/303487. Epub 2011 Jul 13. PMID 22046559
- BACKGROUNDCopelan EA. Hematopoietic stem-cell transplantation. N Engl J Med. 2006 Apr 27;354(17):1813-26. doi: 10.1056/NEJMra052638. No abstract available. PMID 16641398
- BACKGROUNDAversa F, Terenzi A, Tabilio A, Falzetti F, Carotti A, Ballanti S, Felicini R, Falcinelli F, Velardi A, Ruggeri L, Aloisi T, Saab JP, Santucci A, Perruccio K, Martelli MP, Mecucci C, Reisner Y, Martelli MF. Full haplotype-mismatched hematopoietic stem-cell transplantation: a phase II study in patients with acute leukemia at high risk of relapse. J Clin Oncol. 2005 May 20;23(15):3447-54. doi: 10.1200/JCO.2005.09.117. Epub 2005 Mar 7. PMID 15753458
- BACKGROUNDGale RP, Horowitz MM. Graft-versus-leukemia in bone marrow transplantation. The Advisory Committee of the International Bone Marrow Transplant Registry. Bone Marrow Transplant. 1990 Jul;6 Suppl 1:94-7. PMID 2390646
- BACKGROUNDHorowitz MM, Gale RP, Sondel PM, Goldman JM, Kersey J, Kolb HJ, Rimm AA, Ringden O, Rozman C, Speck B, et al. Graft-versus-leukemia reactions after bone marrow transplantation. Blood. 1990 Feb 1;75(3):555-62. PMID 2297567
- BACKGROUNDFerrara JL, Yanik G. Acute graft versus host disease: pathophysiology, risk factors, and prevention strategies. Clin Adv Hematol Oncol. 2005 May;3(5):415-9, 428.