Clinical trial · Interventional
A Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
A Phase I Study of CD45RA+ Depleted Haploidentical Stem Cell Transplantation in Children With Relapsed or Refractory Solid Tumors and Lymphomas
NCT01625351CI-TRIAL-00102696completedPhase 1ClinicalTrials.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)
This is a phase I study designed to determine the feasibility of transplantation using a novel transplant approach that employs a two-stage haploidentical cell infusion following myeloablative conditioning. This strategy, which includes selective depletion of naïve T cells, may speed immune reconstitution thereby potentially reducing the limitations of traditional haploidentical hematopoietic stem cell transplantation (HSCT) and increasing its potential therapeutic application. Additionally, the investigators intend to explore overall survival, event-free survival, hematopoietic cell recovery and engraftment as well as infection rates and complications in these patients.
Conditions
Conditions (13)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Carcinoma | Clear Cell Adenocarcinoma | CURATED_BROADER | 0.80 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Gastrointestinal Tumor | Digestive System Neoplasm | ALIAS | 0.90 |
| Germ Cell Tumor | Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
| Hepatic Tumor | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| alemtuzumab | Drug | Alemtuzumab | ALIAS |
| Busulfan | Drug | Busulfan | ALIAS |
| CliniMACS | Device | — | UNRESOLVED |
| fludarabine | Drug | Fludarabine | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| sirolimus | Drug | Sirolimus | ALIAS |
| stem cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment
- description
- Participants to undergo transplantation. They receive alemtuzumab, fludarabine, sirolimus, busulfan, melphalan, and stem cells. Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy. Cells for infusion are prepared using the CliniMACS System.
- interventionNames
- Drug: alemtuzumab
- Drug: fludarabine
- Drug: sirolimus
- Drug: Busulfan
- Drug: melphalan
- Biological: stem cells
- Device: CliniMACS
Primary outcomes (1)
- measure
- Feasibility of haploidentical HSCT
- timeFrame
- 30 days post transplantation
- description
- Feasibility is defined as engraftment (ANC≥ 500/mm3 for 3 consecutive tests performed on different days) evaluated before day +30.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria - Transplant Recipients: * At least 2 years of age and less than or equal to 21 years of age. * Histologically confirmed solid tumor or lymphoma at original diagnosis: * Ewing Sarcoma Family of Tumors (ESFT) * Gastrointestinal tumors * Germ Cell tumors * Hepatic tumors (including hepatocellular carcinoma and hepatoblastoma) * Lymphoma (including Hodgkin and non-Hodgkin lymphoma) * Kidney tumors (including Wilms tumor, rhabdoid tumors, clear cell carcinoma, and renal cell carcinoma) * Melanoma * Neuroblastoma * Soft tissue sarcoma (including rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma) * Malignancy has no reasonable expectation of cure with available alternative salvage therapy. * Has a suitable human leukocyte antigen (HLA) haploidentical donor available. * At least two weeks since receipt of any biological therapy, chemotherapy, and/or radiation therapy. * Has recovered from all acute NCI Common Toxicity Criteria grade II-IV acute non-hematologic toxicities from prior therapy per the judgment of the PI. * Shortening fraction greater than or equal to 25%. * Creatinine clearance or glomerular filtration rate (GFR) greater than or equal to 50 mL/min/1.73 m2. * Pulse oximetry greater than or equal to 92% on room air * Alanine aminotransferase (ALT) and aspartate transaminase (AST) less than or equal to3 times the upper limit of the institution-established normal range. * Direct bilirubin less than or equal to 3.0 mg/dL. * Karnofsky or Lansky performance score of greater than or equal to 50. Exclusion Criteria - Transplant Recipients: * Newly diagnosed patients with no prior attempt at curative therapy. * Any primary or active central nervous system (CNS) malignancy, including metastatic disease. * Any active or prior malignant or pre-malignant condition of the bone marrow, excluding metastasis of the primary malignancy. * Prior allogeneic hematopoietic stem cell transplant. * Prior autologous stem cell transplant within previous 3 months. * Allergy to murine products or positive human anti-mouse antibody (HAMA). * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding. Inclusion Criteria - Donors: * At least 18 years of age. * Partially HLA matched family member. * Human immunodeficiency virus (HIV) negative. Exclusion Criteria - Donors: * (Female only) Known pregnancy (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment). * (Female only) Breast feeding.
References
Publications (0)
Data not yet available
No reference posted for this study.