Clinical trial · Interventional
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells (PBSC)
Nonmyeloablative Stem Cell Transplantation With CD8-depleted or Unmanipulated Peripheral Blood Stem Cells: A Prospective Randomized Phase II Trial
- 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)
Prospective randomized study of allogeneic minitransplantation from HLA-identical family or unrelated donors comparing unmanipulated or CD8-depleted PBSC. The conditioning regimen will be 2 Gy TBI alone (related donor with low-risk of transplant rejection) or 2 Gy TBI and 3 x 30 mg/m2 fludarabine (unrelated donor or high risk of transplant rejection). Patients will receive a short but intensive immunosuppressive treatment (cyclosporine and mycophenolate mofetil) to ensure both graft-versus-host and host-versus-graft tolerance. The rationale for using PBSC instead of marrow transplant is to avoid general anesthesia of the donor and to minimize the risk of rejection. The rationale for CD8+ depletion is to diminish the risk of GVHD after PBSC transplantation or DLI.
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 |
|---|---|---|---|
| Hematologic Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD8-depleted PBSC after nonmyeloablative conditioning | Procedure | — | UNRESOLVED |
| Unmanipulated PBSC after nonmyeloablative conditioning | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Unmanipulated PBSC
- interventionNames
- Procedure: Unmanipulated PBSC after nonmyeloablative conditioning
- type
- EXPERIMENTAL
- label
- 2
- description
- CD8-Depleted PBSC
- interventionNames
- Procedure: CD8-depleted PBSC after nonmyeloablative conditioning
Primary outcomes (2)
- measure
- Incidence of acute GVHD in CD8-depleted versus unmanipulated groups
- timeFrame
- 180 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
1. Patients
1.1. Diseases
Malignant diseases confirmed histologically and not rapidly progressing:
* Hematologic malignancies
* AML;
* ALL;
* CML and other myeloproliferative disorders;
* MDS;
* Multiple myeloma;
* CLL;
* Non-Hodgkin's lymphoma;
* Hodgkin's disease.
* Non-hematologic malignancies
* Renal cell carcinoma (metastatic).
1.2. Inclusion criteria
* Male or female; female patients must use a reliable contraception method;
* Age lower than 70 yrs (family donor) or lower than 65 yrs (unrelated donor);
* HIV negative;
* No terminal organ failure;
* No uncontrolled infection, arrhythmia or hypertension;
* Family donor (HLA-identical) or unrelated donor (matched for A-B by low resolution typing and for DRB1-DQB1 by high resolution typing);
* No previous radiation therapy precluding the use of 2 Gy TBI
* Informed consent given by patient or his/her guardian if of minor age.
1.3. Clinical situations
* Theoretical disease indication for a standard allo-transplant, but not feasible because:
* Age \> 55 yrs;
* Unacceptable end organ performance;
* Patient's refusal.
* Indication for a standard auto-transplant:
* perform mini-allotransplantation 2-6 months after standard autotransplant.
* Not an indication for intensification but a potential candidate for cellular immunotherapy.
2. Donors
2.1. Inclusion criteria
* Related to the recipient (sibling, parent or child) or unrelated;
* Male or female;
* Weight \> 15 Kg (because of leukapheresis);
* HIV negative;
* No major contraindication for allogeneic PBSC donation by generally accepted criteria;
* Informed consent given by donor or his/her guardian if of minor age.
2.2. Exclusion criteria
* Any condition not fulfilling inclusion criteria;
* Unable to undergo leukapheresis because of poor vein access or other reasons.References
Publications (0)
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