Clinical trial · Interventional
Pooled Unrelated Donor Umbilical Cord Blood Transplant For Hematologic Malignancy Needing Allogeneic Stem Cell Transplant Without Related HLA-Match
A Phase II Study Of Pooled Unrelated Donor Umbilical Cord Blood (UCB) Transplant For Patients With Hematologic Malignancies Needing Allogeneic Stem Cell Transplant But Do Not Have A Related HLA-Matched Donor
NCT01500161CI-TRIAL-00012730terminatedPhase 2ClinicalTrials.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): Insufficient accruals
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the multi-lineage hematopoietic chimerism for unrelated umbilical cord blood (UCB) grafts pooled from two to three cord blood units. Also to evaluate the toxicity, and antitumor responses of pooled unrelated UCB transplants.
Conditions
Conditions (9)
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 Lymphocytic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
| Aplastic Anemia | — | UNRESOLVED | — |
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Hodgkins Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| Carmustine | Drug | Carmustine | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- The following conditioning regimens will be used, depending on the underlying hematologic malignancies. Conditioning regimens with Busulfan/clofarabine and with fludarabine/melphalan will be used for all patients except those with Non-Hodgkin's lymphoma when the conditioning regimen of BCNU, Etoposide, ARA-C and Melphalan will be used.
- interventionNames
- Drug: Busulfan
- Drug: Clofarabine
- Drug: Fludarabine
- Drug: Melphalan
- Drug: Carmustine
- Drug: Etoposide
- Drug: Cytarabine
Primary outcomes (1)
- measure
- evaluate the multi-lineage hematopoietic chimerism for unrelated UCB grafts pooled from two to three cord blood units
- timeFrame
- Will be tested after granulocyte engraftment - which will happen at an average of 28 days post-transpant
- description
- Blood will be obtained for DNA preparation for VNTR chimerism study post transplant after time of engraftment, which will happen at an average of 28 days post-trasplant.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \< 65 years with hematologic malignancies needing stem cell transplant but do not have HLA-matched sibling donor. Patients with the following diagnosis will be included: * AML in first or subsequent complete or partial remissions * ALL in first or subsequent complete or partial remissions * CLL in second remission or more advanced disease * CML who has failed tyrosine kinase inhibitors * Hodgkin's disease who relapse after autologous transplant * Non-Hodgkin's lymphoma who relapse after autologous transplant or NK-cell lymphoma in CR1 * Aplastic anemia patients * Multiple myeloma in second remission or moer advanced disease, including those who have failed an autologous transplant * Myelodysplastic syndrome in first or subsequent complete or partial remission * Patients must have 6/6, 5/6 or 4/6 molecular matches from unrelated UCB donors. Matching will be done for A, B, and DR. Matching at DR will be confirmed by molecular typing. * Patients must be documented to be HIV negative. Screening must have been performed within previous 6 months. * Patients must be able to give written consent. Exclusion Criteria: * Patient is excluded if all of the Inclusion criteria above isn't met.
References
Publications (8)
- BACKGROUNDBalduzzi A, Gooley T, Anasetti C, Sanders JE, Martin PJ, Petersdorf EW, Appelbaum FR, Buckner CD, Matthews D, Storb R, Sullivan KM, Hansen JA. Unrelated donor marrow transplantation in children. Blood. 1995 Oct 15;86(8):3247-56. PMID 7579422
- BACKGROUNDPetersdorf EW, Longton GM, Anasetti C, Martin PJ, Mickelson EM, Smith AG, Hansen JA. The significance of HLA-DRB1 matching on clinical outcome after HLA-A, B, DR identical unrelated donor marrow transplantation. Blood. 1995 Aug 15;86(4):1606-13. PMID 7632970
- BACKGROUNDLaughlin MJ, Barker J, Bambach B, Koc ON, Rizzieri DA, Wagner JE, Gerson SL, Lazarus HM, Cairo M, Stevens CE, Rubinstein P, Kurtzberg J. Hematopoietic engraftment and survival in adult recipients of umbilical-cord blood from unrelated donors. N Engl J Med. 2001 Jun 14;344(24):1815-22. doi: 10.1056/NEJM200106143442402. PMID 11407342
- BACKGROUNDWagner JE, Kernan NA, Steinbuch M, Broxmeyer HE, Gluckman E. Allogeneic sibling umbilical-cord-blood transplantation in children with malignant and non-malignant disease. Lancet. 1995 Jul 22;346(8969):214-9. doi: 10.1016/s0140-6736(95)91268-1. PMID 7616801
- BACKGROUNDWagner JE, Rosenthal J, Sweetman R, Shu XO, Davies SM, Ramsay NK, McGlave PB, Sender L, Cairo MS. Successful transplantation of HLA-matched and HLA-mismatched umbilical cord blood from unrelated donors: analysis of engraftment and acute graft-versus-host disease. Blood. 1996 Aug 1;88(3):795-802. PMID 8704232
- BACKGROUNDKurtzberg J, Laughlin M, Graham ML, Smith C, Olson JF, Halperin EC, Ciocci G, Carrier C, Stevens CE, Rubinstein P. Placental blood as a source of hematopoietic stem cells for transplantation into unrelated recipients. N Engl J Med. 1996 Jul 18;335(3):157-66. doi: 10.1056/NEJM199607183350303. PMID 8657213
- BACKGROUNDGluckman E, Rocha V, Boyer-Chammard A, Locatelli F, Arcese W, Pasquini R, Ortega J, Souillet G, Ferreira E, Laporte JP, Fernandez M, Chastang C. Outcome of cord-blood transplantation from related and unrelated donors. Eurocord Transplant Group and the European Blood and Marrow Transplantation Group. N Engl J Med. 1997 Aug 7;337(6):373-81. doi: 10.1056/NEJM199708073370602.