Clinical trial · Interventional
Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation
Adaptive Randomization of Fludarabine-Melphalan Versus Fludarabine-Cyclophosphamide Conditioning Regimen in Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation Using HLA-Matched Related Donor for Metastatic Renal Cell Carcinoma
- 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, study terminated.
Summary
Brief summary (as posted)
Primary Objectives: 1. To compare the overall survival of metastatic renal cell carcinoma (RCC) patients undergoing HLA-matched related donor nonmyeloablative allogeneic hematopoietic stem cell transplantation (NST) using fludarabine-melphalan (FM) versus fludarabine-cyclophosphamide (FC) conditioning regimen. 2. To assess both cytotoxic T lymphocyte reactivity and antibodies activity against potential tumor antigenic peptides involved in graft-versus-RCC effect. Secondary Objectives: 1. To study the patient characteristics of metastatic RCC patients who undergo NST and those who do not undergo NST. 2. To compare the incidence of Day-100 treatment-related mortality in FM group and FC group.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Stem Cell Transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fludarabine + Cyclophosphamide with ASCT
- description
- ASCT=Allogeneic Hematopoietic Stem Cell Transplantation
- interventionNames
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Procedure: Stem Cell Transplant
- type
- EXPERIMENTAL
- label
- Fludarabine + Melphalan with ASCT
- description
- ASCT=Allogeneic Hematopoietic Stem Cell Transplantation
- interventionNames
- Drug: Fludarabine
- Drug: Melphalan
- Procedure: Stem Cell Transplant
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. For registration: Willing to undergo allogeneic transplantation. 2. For registration: Age equal to or less than 65 years old. 3. For registration: Metastatic RCC with predominant conventional cell type. 4. For registration: Prior nephrectomy. 5. For registration: Stage IV RCC. If patient has prior single brain metastasis treated with complete surgical resection or stereotactic radiation therapy, no recurrence or brain edema from the end of treatment for at least 6 months has to be shown by radiological imaging. 6. For registration: Zubrod performance status \< one. 7. For registration: Potential related donor for allogeneic stem cell transplantation. 8. For registration: At least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment. 9. For registration: Signed an informed consent. 10. For transplantation: Zubrod performance status \< one. 11. For transplantation: An HLA-matched (defined as 6/6 matches) related donor. 12. For transplantation: Failed at least one prior treatment for metastatic RCC. Radiation therapy or surgery is not counted as a treatment. 13. For transplantation: Adequate major organ functions (see section 4.17-4.20). 14. For transplantation: Signed an informed consent for allogeneic stem cell transplantation. Exclusion Criteria: 1. For registration: Prior history of allogeneic stem cell transplantation. 2. For registration: Histologic feature with predominant non-conventional cell type. 3. For registration: Multiple brain metastasis. 4. For registration: Life expectancy is severely limited by concomitant illness. 5. For transplantation: Multiple brain metastasis. 6. For transplantation: Life expectancy is severely limited by concomitant illness. 7. For transplantation: Clinically significant active infections. 8. For transplantation: HIV infection. 9. For transplantation: Chronic active hepatitis 10. For transplantation: Pregnant or lactating women. 11. For transplantation: Has all three risk factors: high serum lactate dehydrogenase, low hemoglobin, high corrected serum calcium.
References
Publications (0)
Data not yet available