Clinical trial · Interventional
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematologic Cancer
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patients With Advanced Hematopoietic Malignancies
- 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 chemotherapy, such as fludarabine, busulfan, and etoposide, before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and tacrolimus and prednisone after transplant may stop this from happening. PURPOSE: This phase I trial is studying how well donor umbilical cord blood transplant works in treating patients with advanced hematologic cancer.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Multiple Myeloma and Plasma Cell Neoplasm | — | UNRESOLVED | — |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic stem cell transplantation | Procedure | — | UNRESOLVED |
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| prednisone | Drug | Prednisone | ALIAS |
| sargramostim | Biological | — | UNRESOLVED |
| tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cord blood transplant
- interventionNames
- Biological: anti-thymocyte globulin
- Biological: sargramostim
- Drug: busulfan
- Drug: etoposide
- Drug: fludarabine phosphate
- Drug: prednisone
- Drug: tacrolimus
- Procedure: allogeneic hematopoietic stem cell transplantation
- Procedure: umbilical cord blood transplantation
Primary outcomes (1)
- measure
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies
- timeFrame
- up to 24 months post-transplant
- description
- Determine the safety and feasibility of performing donor umbilical cord blood transplantation (UCBT) in patients with advanced hematologic malignancies, in terms of \> 80% engraftment rate at day 100 post-transplant and ≤ 50% transplant-related mortality.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following advanced hematologic malignancies:
* Acute myeloid leukemia (AML) meeting the following criteria:
* Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
* High-risk cytogenetics (-7, -7q, -5, -5q, t\[6,9\], t\[9,11\], complex, Philadelphia chromosome positive \[Ph+\])
* AML evolved from prior myelodysplasia
* AML secondary to prior chemotherapy
* Failed to achieve remission
* In second or subsequent remission
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Myelodysplastic syndromes (MDS) with high-risk features
* International Prognostic Scoring System (IPSS) score intermediate -2 or high-risk
* Marrow blasts ≤ 20% (may be achieved using chemotherapy)
* Acute lymphoblastic leukemia meeting the following criteria:
* Not expected to be curable with chemotherapy and meets ≥ 1 of the following criteria:
* High-risk cytogenetics (Ph+, t\[4,11\], 11q23 abnormalities, and monosomy 7)
* Required \> 1 induction course to achieve remission
* Failed to achieve remission
* In second or subsequent remission
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Chronic myelogenous leukemia meeting ≥ 1 of the following criteria:
* Accelerated phase
* Chronic phase refractory to imatinib mesylate
* Blastic phase
* Marrow blasts ≤ 10% (may be achieved using chemotherapy)
* Multiple myeloma meeting 1 of the following criteria:
* Stage II or III disease with \> first relapse or refractory disease
* Newly diagnosed disease with chromosome 13 abnormalities
* Lymphoma meeting the following criteria:
* One of the following subtypes:
* Diffuse large cell lymphoma
* Mantle cell lymphoma
* Peripheral T-cell lymphoma
* T-natural killer (NK) cell lymphoma
* Hodgkin's lymphoma
* Disease failed to respond to primary therapy, progressed, or recurred after prior therapy
* Patients who have failed autologous stem cell transplantation are eligible provided it has been \> 1 year since transplant
* No rapid progression of malignant disease
* Not eligible for autologous stem cell transplantation
* Available umbilical cord blood (1-3 units) donor matching at ≥ 4 of 6 HLA antigens (A, B, and DR)
* Patients with an HLA-identical or 1 antigen-mismatched related donor OR a potential HLA-matched unrelated donor matching at \> 6/8 (A, B, C, DR) alleles are not eligible
PATIENT CHARACTERISTICS:
* ECOG performance status 0-2
* Creatinine \< 2.0 mg/dL
* Creatinine clearance \> 40 mL/min
* Bilirubin \< 2.0 mg/dL
* AST and alkaline phosphatase \< 3 times upper limit of normal
* Hepatitis C and active hepatitis B allowed if patient has ≤ grade 2 inflammation or fibrosis by liver biopsy
* Ejection fraction \> 40% by echocardiogram or MUGA
* DLCO \> 40% of predicted
* Not pregnant or nursing
* Negative pregnancy test
* No known HIV infection
* No active infection requiring ongoing antibiotic treatment
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available