Clinical trial · Interventional
T-cell Depleted Alternative Donor Transplantation
A Phase II Study Using the CliniMACS® Device for CD34+ Cell Selection and T Cell Depletion for Graft-versus-Host Disease Prophylaxis in Alternative Donor Stem Cell Transplant Recipients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor/ PI leaving institution, no plans to continue this research at this time
Summary
Brief summary (as posted)
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary objectives include evaluation of engraftment, immune recovery, and post-transplant infections. Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant disease will be included in the study. The recipients will be grouped into one of two groups based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The patient will receive a conditioning regimen including chemotherapy drugs and/or total body irradiation based on the disease for which the transplant is performed.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Bone Marrow Failure | — | UNRESOLVED | — |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Hemoglobinopathy | — | UNRESOLVED | — |
| Immune Deficiency | — | UNRESOLVED | — |
| Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CliniMACS® (T cell depletion) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CliniMACS® (T cell depletion)
- description
- Recipients will receive T cell-depleted PBSC from eligible donors after receiving conditioning therapy using CliniMACS® device.
- interventionNames
- Device: CliniMACS® (T cell depletion)
Primary outcomes (1)
- measure
- Number of Participants With Severe Graft vs. Host Disease (GVHD).
- timeFrame
- Within 30 days after stem cell transplant
- description
- Severe GVHD defined as grade III/IV GVHD.
Secondary outcomes (8)
- measure
- Number of Participants With Engraftment and Time to Engraftment
- timeFrame
- Within 28 days after stem cell transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Age \< 30 years * Patient must have a malignant or non-malignant disease that can benefit from alternative stem cell transplantation. Examples include acute and chronic leukemias, myelodysplastic syndrome, lymphoma, severe acquired and congenital cytopenias, white and red blood cell abnormalities, and immunodeficiencies. * Patients with acute lymphoblastic leukemia must be in morphological remission (\< 5% blasts) at the time of transplant. Patients with acute non-lymphocytic leukemia will preferably be in morphologic remission but may be enrolled when aplastic after chemotherapy or with \< 20% blasts. Patients with lymphoma must be in complete or close to complete remission (if residual adenopathy, PET scan must be negative or only have slight uptake, eg. SUV \< 2). * Patients must lack a healthy HLA-identical related donor of at least one year of age. * Patient must have a mismatched related or an unrelated donor who is: 1. Able to receive G-CSF and undergo apheresis either through placement of catheters in antecubital veins or a temporary central venous catheter, 2. Healthy, 3. Willing, 4. For recipients of an unrelated donor transplant, recipient eligibility will be restricted as follows if in the judgment of the recipients' transplant physician, the recipient cannot receive a transplant with combined positive and negative fractions as described in Section 6.1.3.2 or an unmanipulated PBSC product. 5. Meets eligibility criteria for donors. * If only one mismatched related relative is available, an acceptable unrelated donor must be identified as a backup. * Patient or authorized guardian must sign informed consent for this study. Exclusion Criteria: * Patient with an anticipated life expectancy of \< 1 month * Active infectious hepatitis or CMV infection * HIV or HTLV-I/II infection * Serious infection (bacterial, fungal, viral) within the last 4 weeks * Cardiac ejection fraction \< 45%; can be lower if patient is not in clinical cardiac failure and a reduced intensity conditioning regimen is used. * Creatinine clearance \<60 ml/min/1.72 m2; can be lower if a reduced intensity conditioning regimen is used. * Pulmonary diffusion capacity (adjusted for Hgb), FEV1, or FVC \<60% of predicted or O2 sat \< 94% if unable to perform PFTs; can be lower if a reduced intensity conditioning regimen is used. * Serum ALT \> 3 x upper limit of normal (can be up to 5 x upper limit of normal if a reduced intensity conditioning regimen is used) or bilirubin \> 2. The bilirubin criteria for sickle cell disease patients is direct bilirubin \>2x upper limit of normal. * Performance score (Lansky/Karnofsky) \< 50 * Any condition that compromises compliance with the procedures of this protocol, as judged by the principal investigator.
References
Publications (1)
- DERIVEDGilman AL, Eckrich MJ, Epstein S, Barnhart C, Cannon M, Fukes T, Hyland M, Shah K, Grochowski D, Champion E, Ivanova A. Alternative donor hematopoietic stem cell transplantation for sickle cell disease. Blood Adv. 2017 Jun 28;1(16):1215-1223. doi: 10.1182/bloodadvances.2017005462. eCollection 2017 Jul 11. PMID 29296761