Clinical trial · Interventional
Treosulfan-based Conditioning for Allogeneic Stem-cell Transplantation (SCT) in Lymphoid Malignancies
Phase II Trial of Fludarabine Combined With Intravenous Treosulfan and Allogeneic Hematopoietic Stem-cell Transplantation in Patients With Lymphatic Malignancies
NCT01079013CI-TRIAL-00021834unknownPhase 2ClinicalTrials.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)
The study hypotheses is that the introduction of dose escalated treosulfan, in substitution to busulfan or melphalan, will reduce toxicity after allogeneic transplantation while improving disease eradication in patients with lymphoid malignancies not eligible for standard transplantation.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| treosulfan | Drug | Treosulfan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- treosulfan
- interventionNames
- Drug: treosulfan
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 2 years after transplantation
Secondary outcomes (4)
- measure
- treatment-related mortality
- timeFrame
- 2 year after transplantation
- measure
- GVHD
- timeFrame
- 2 year after transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 68 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age less than physiologic 68 years. 2. Patients with NHL and HL with an indication for allogeneic transplantation as follows: * Aggressive lymphoma and Hodgkin lymphoma; relapse after autologous transplants * Follicular lymphoma; failure of at least one prior regimen 3. Disease must be at chemo-sensitive or stable status to prior therapy before transplant. 4. Patients must have an HLA matched related or unrelated donor willing to donate either peripheral blood stem cells or bone marrow. Matching is based on high-resolution class I (HLA-A, -B, -C) and class II (HLA-DRB1, -DQB1) typing. The goal is to transplant \> 3 x 106 CD34+ cells per kg body weight of the recipient 5. Patients must sign written informed consent 6. Adequate birth control in fertile patients Exclusion Criteria: 1. Overt progressive disease prior to transplantation. 2. Bilirubin \> 3.0 mg/dl, transaminases \> 3 times upper normal limit 3. Creatinine \> 2.0 mg/dl 4. ECOG-Performance status \> 2 5. Uncontrolled infection 6. Pregnancy or lactation 7. Abnormal lung diffusion capacity (DLCO \< 40% predicted) 8. Severe cardiovascular disease 9. CNS disease involvement 10. Pleural effusion or ascites \> 1 liter 11. Known hypersensitivity to fludarabine or treosulfan 12. Psychiatric conditions/disease that impair the ability to give informed consent or to adequately co-operate
References
Publications (0)
Data not yet available
No reference posted for this study.