Clinical trial · Interventional
Phase 2 Haplotype Mismatched HSCT in Patients With Hematological Malignancies
A Phase II Trial of Haplotype Mismatched Hematopoietic Stem Cell Transplantation Using Highly Purified CD34 Cells in Patients With Hematological Malignancies
NCT00593554CI-TRIAL-00032449terminatedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to determine if haplotype-mismatched HSCT is associated with an improvement in treatment-related mortality (TRM) rate at 6 months.
Conditions
Conditions (4)
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 |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Myelodysplasia | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine | Drug | Fludarabine | ALIAS |
| Palifermin | Drug | — | UNRESOLVED |
| Rabbit ATG | Biological | — | UNRESOLVED |
| Thiotepa | Drug | Thiotepa | ALIAS |
| Total Body Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Total body Irradiation; Thiotepa; Fludarabine; Rabbit ATG;
- interventionNames
- Radiation: Total Body Irradiation
- Drug: Thiotepa
- Drug: Fludarabine
- Biological: Rabbit ATG
- type
- EXPERIMENTAL
- label
- 2
- description
- Palifermin; Total Body Irradiation; Thiotepa; Fludarabine; Rabbit ATG
- interventionNames
- Radiation: Total Body Irradiation
- Drug: Thiotepa
- Drug: Fludarabine
- Biological: Rabbit ATG
- Drug: Palifermin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have histologically documented AML, ALL, MDS, CML, Acute myeloid leukemia (AML) with one or more of the following criteria * CR 1 with poor risk features * CR 2, or higher order CR * Acute lymphoblastic leukemia (ALL) with one of the following criteria * CR 1 with poor risk features * CR 2, or higher order CR * Myelodysplasia, RAEB I * Donor has been identified * Age ≤ 65 years. * Performance Status 0-1. Exclusion Criteria: * Patients relapsing \<6 months after autologous SCT are not eligible. * Patients with active infections requiring oral or intravenous antibiotics are not eligible for enrollment until resolution of infection. * Non-pregnant and non-nursing
References
Publications (0)
Data not yet available
No reference posted for this study.