Clinical trial · Interventional
Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies
Transplantation of Hematopoietic Progenitors From Haploidentical Donor With Selective in Vitro Depletion Allo-reactive Lymphocytes in Patient With High Risk Hematological Malignancies.
- 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)
Therapeutic exploratory study to evaluate safety, open, nonrandomized, multicentre, prospective, of cohort of patients who will receive different doses of allo-depleted lymphocytes . This project joins in this pioneering worldwide initiative with its own technology based on the use of proteasome inhibitors in vitro, which advantages are, over other methods described, the continuing viability of regulatory T cells and the use of a product to generate allo-depletion that, contrary to those reported by other research groups, it does not pose problems from the point of view of its use or toxicity as we employ a drug widely used clinically by intravenous administration.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Transplant-Related Hematologic Malignancy | Transplant-Related Hematologic Malignancy | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allo-depleted lymphocyte infusion | Other | — | UNRESOLVED |
| Haploidentical transplantation of hematopoietic progenitors | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- PLACEBO_COMPARATOR
- label
- Group 0
- description
- Haploidentical transplantation of hematopoietic progenitors
- interventionNames
- Other: Haploidentical transplantation of hematopoietic progenitors
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Allo-depleted lymphocyte infusion dose: 1x105 CD3/Kg
- interventionNames
- Other: Allo-depleted lymphocyte infusion
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Allo-depleted lymphocyte infusion dose: 3x105 CD3/Kg
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients aged between 16 and 50 years. * Diagnosed as Hematological malignancy candidates to allogeneic transplant lacking of related or unrelated suitable donor (is more than one Human leukocyte antigen (HLA) mismatched over 8 antigens) and who don't have a cord with an adequate cellularity. The minimum period of search to be able to include the patient in the trial, currently considering the medium to find a suitable donor to be 2 months, it is set to 10 weeks, although in specific situations in which the responsible physician considers that the patient has a high risk of relapse, it may be proceed with inclusion before that period. These cases will be assessed individually with the trial coordinator. Exclusion Criteria: * General condition\> Eastern Cooperative Oncology Group (ECOG) scale 2. * Left Ventricular ejection fraction (LVEF) \<39%. * Diffusion capacity of lung for carbon monoxide (DLCO) and forced vital capacity (FVC) \<39% of the theoretical values. * Impaired liver function (total bilirubin higher than 2 mg / dL and / or transaminases higher than 3 times the normal maximum. * Creatinine clearance \<50 mL / minute. * Presence of symptomatic heart, liver cirrhosis or chronic active hepatitis. * Active tuberculosis. * Serious diseases which prevent chemotherapy treatments. * Associated neoplasias (active neoplasias which, according to the opinion of the investigator and the sponsor, could jeopardize patient safety). * Presence of associated psychiatric pathology. * HIV infection.
References
Publications (0)
Data not yet available