Clinical trial · Interventional
Donor Stem Cell Boost in Treating Patients With Low Blood Cells After Donor Stem Cell Transplant
Compassionate Use of the CliniMACS® CD34 Reagent System for Patients Requiring a Post Hematopoietic Stem Cell Transplant Boost of Donor Hematopoietic Stem Cells
NCT01660347CI-TRIAL-00089262withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This clinical trial studies how well donor stem cell boost works in treating patients with low blood cells after donor stem cell transplant. Donor stem cell boost may increase low blood cell counts caused by hematologic cancer or its treatment.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anemia | — | UNRESOLVED | — |
| Hematopoietic/Lymphoid Cancer | — | UNRESOLVED | — |
| Lymphopenia | — | UNRESOLVED | — |
| Neutropenia | — | UNRESOLVED | — |
| Thrombocytopenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic hematopoietic stem cell transplantation | Biological | — | UNRESOLVED |
| Management of therapy complications | Procedure | — | UNRESOLVED |
| Peripheral blood stem cell transplantation | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (allogeneic PBSCT boost)
- description
- Patients undergo allogeneic PBSCT boost from cells selected for CD34+ using the CliniMACS CD34 Reagent System.
- interventionNames
- Biological: Allogeneic hematopoietic stem cell transplantation
- Biological: Peripheral blood stem cell transplantation
- Procedure: Management of therapy complications
Primary outcomes (6)
- measure
- Etiologies of post HSCT cytopenias
- timeFrame
- Up to 8 weeks
- description
- Will be collected and reported descriptively.
- measure
- CD34+/kg and CD3+/kg cell doses in the infused CD 34+ selected boost products
- timeFrame
- Up to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. No evidence of active disease as measured by staging studies pertinent to the particular diagnosis within 1 month of the CD 34+ boost 2. Full donor chimerism as manifested by a ≥ 90% donor peripheral blood total, MNC, and T cell chimerism result on the last two studies prior to the planned CD 34+ boost, with the second study performed within 1 month of the infusion. 3. HHV-6 and CMV negative by PCR for at least 1 month prior to the CD 34+ boost as measured by at least 2 assays within the month timeframe 4. ANC of \< 1000 10\^6/L or maintenance of an ANC ≥ 1000 10\^6/L only with white cell growth factor support 5. Requirement for red cell transfusion to maintain a hemoglobin of ≥ 9.0 g/dL 6. Requirement for red cell transfusion to avoid symptomatic anemia in patients with hemoglobin values of ≤ 11.0 g/dL 7. Requirement for platelet transfusion to maintain a platelet count of ≥ 20 10\^9/L 8. Requirement for platelet transfusion to avoid bleeding in patients with platelet counts ≤ 50 109/L 9. No signs of active acute GVHD (excluding stages I-II skin GVHD)
References
Publications (0)
Data not yet available
No reference posted for this study.