Clinical trial · Interventional
Donor Umbilical Cord Blood Transplant After Cyclophosphamide, Fludarabine Phosphate, and Total-Body Irradiation in Treating Patients With Hematologic Disease
Transplantation of Umbilical Cord Blood From Unrelated Donors in Patients With Haematological Diseases Using a Reduced Intensity Conditioning Regimen
- 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)
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor umbilical cord blood transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining abnormal cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of donor umbilical cord blood transplant after cyclophosphamide, fludarabine phosphate, and total-body irradiation in treating patients with hematologic disease.
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 |
|---|---|---|---|
| Hematopoietic/Lymphoid Cancer | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mycophenolate mofetil | Drug | — | UNRESOLVED |
| nonmyeloablative allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| total-body irradiation | Radiation | — | UNRESOLVED |
| umbilical cord blood transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Non-relapse mortality at day 100
Secondary outcomes (3)
- measure
- Incidence of grades II-IV and III-IV acute graft-vs-host disease (GVHD) at day 100 and chronic GVHD at 1 year
- measure
- Mixed chimerism
- measure
- Hemopoietic recovery
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 60 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of high-risk, advanced or poorly responding hematological disease for which a reduced-intensity hemopoietic stem cell transplantation is likely to be effective * Disease status is such that there is no alternative therapy likely to achieve a cure or provide a significant prolongation of disease-free survival * No chronic myelogenous leukemia in first chronic phase responding to imatinib or refractory blast crisis * No acute leukemia in morphological relapse/persistent disease (defined as \> 5% blasts in normocellular bone marrow) * No malignant disease that is refractory to or progressive on salvage therapy * No myelofibrosis * Donor must be matched at HLA-A and -B at antigen level and HLA-DRB1 at allelic level * No available 5-6/6 HLA-A, -B, -DRB1 matched sibling donor OR 10/10 unrelated volunteer donor PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 60-100% OR Lansky PS 50-100% (pediatrics) * Transaminases \< 5 times upper limit of normal (ULN) * Bilirubin \< 3 times ULN * Creatinine clearance \> 50 mL/min * DLCO \> 50% predicted * No supplemental oxygen requirements * Not pregnant or nursing * Negative pregnancy test * No HIV or HTLV (I and II) antibody positivity or evidence of infection * No acquired aplastic anemia * No decompensated congestive heart failure or uncontrolled arrhythmia and left ventricular ejection fraction ≥ 35% * No current active serious infection, in particular uncontrolled fungal infection * No congenital immune deficiencies PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 6 months since prior exposure to combination chemotherapy OR only 1 course of induction combination chemotherapy for myelodysplastic syndromes or acute myeloid leukemia (please discuss with study coordinator/s if this course contained fludarabine) * At least 6 months since prior myeloablative bone marrow transplantation * No prior irradiation that precludes the safe administration of an additional dose of 200 cGy of total-body irradiation * No prior autograft
References
Publications (1)
- DERIVEDHough R, Lopes A, Patrick P, Russell N, Raj K, Tholouli E, A Snowden J, Collin M, El-Mehidi N, Lawrie A, Clifton-Hadley L, Veys P, Craddock C, Mackinnon S, Cook G, Shaw B, Marks D. Primary graft failure, but not relapse, may be identified by early chimerism following double cord blood unit transplantation. Blood Adv. 2022 Apr 12;6(7):2414-2426. doi: 10.1182/bloodadvances.2021005106. PMID 34700343