Clinical trial · Interventional
Umbilical Cord Blood Transplantation in Treating Patients With High-Risk Hematologic Cancer
A Pilot Study of Unrelated Umbilical Cord Blood Transplantation in Patients With High Risk Hematologic 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: Umbilical cord blood transplantation may allow doctors to give higher doses of chemotherapy or radiation therapy and kill more cancer cells. PURPOSE: This phase II trial is studying allogeneic umbilical cord blood transplantation to see how well it works when given with chemotherapy or radiation therapy in treating patients with high-risk hematologic cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic/Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (7)
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- rates of durable engraftment in patients
- timeFrame
- day 42
- description
- The primary study end point will be hematologic engraftment. Engraftment is defined as achieving ANC larger than or equal to 500 ul/mm3 of donor origin for three consecutive measurements on different days by day +42.
Secondary outcomes (2)
- measure
- Event-free survival by clinical and pathological disease assessment
- timeFrame
- at disease progression or death
- measure
- incidence of recurrent disease in patients post UCB transplant
- timeFrame
- post transplant
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 54 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed high risk malignancy including:
* Acute nonlymphocytic leukemia (ANLL) after induction failure, or in first complete remission with high risk features including stem cell or biphenotypic classification (acute myeloid leukemia (AML) M0), erythroleukemia (AML M6), acute megakaryocytic leukemia (AML M7), cytogenic markers indicative of poor prognosis, or failure to achieve complete remission after standard induction therapy
* Acute lymphocytic leukemia (ALL) or ANLL in second or subsequent remission
* Chronic myeloid leukemia (CML) in chronic phase
* CML with accelerated phase or blast crisis are eligible after reinduction chemotherapy converts disease to chronic phase
* High risk ALL in first complete remission
* Myelodysplastic syndrome with evidence of evolution to acute myeloid leukemia
* Refractory anemia with excess blasts
* Refractory anemia with excess blasts in transformation
* Non-Hodgkin's lymphoma (NHL), ANLL, or ALL with recurrent disease after autologous stem cell transplantation
* Must also meet all the following conditions:
* No HLA-ABC/DR identical related bone marrow or UCB donor
* No 5/6 antigen matched related bone marrow or UCB donor
* Condition precludes waiting to search and find a donor in the National Marrow Donor Registry
* Must have an available serologic matched umbilical cord blood unit in the New York Blood Center's Placental Blood Project
* No active CNS disease
PATIENT CHARACTERISTICS:
Age:
* Under 55 at time of umbilical cord blood transplantation
Performance status:
* Zubrod 0-1
* Karnofsky 80-100%
Life expectancy:
* At least 3 months
Hematopoietic:
* For patients with ALL or ANLL in remission, CML in chronic phase, or NHL without marrow involvement who elect to undergo autologous peripheral blood stem cell collection and storage:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
* ALT/AST no greater than 4 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* Normal cardiac function by echocardiogram or radionuclide scan (shortening fraction or ejection fraction at least 80% of normal value for age)
Pulmonary:
* FVC and FEV\_1 at least 60% of predicted for age
* For adults:
* DLCO at least 60% of predicted
Other:
* HIV negative
* No active infections at time of autologous stem cell harvest or pretransplant cytoreduction
* Not pregnant or nursing
* Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior autologous stem cell transplantation allowed
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specifiedReferences
Publications (4)
- RESULTLesniewski ML, Haviernik P, Weitzel RP, Kadereit S, Kozik MM, Fanning LR, Yang YC, Hegerfeldt Y, Finney MR, Ratajczak MZ, Greco N, Paul P, Maciejewski J, Laughlin MJ. Regulation of IL-2 expression by transcription factor BACH2 in umbilical cord blood CD4+ T cells. Leukemia. 2008 Dec;22(12):2201-7. doi: 10.1038/leu.2008.234. Epub 2008 Sep 4. PMID 18769450
- RESULTvan Heeckeren WJ, Fanning LR, Meyerson HJ, Fu P, Lazarus HM, Cooper BW, Tse WW, Kindwall-Keller TL, Jaroscak J, Finney MR, Fox RM, Solchaga L, Forster M, Creger RJ, Laughlin MJ. Influence of human leucocyte antigen disparity and graft lymphocytes on allogeneic engraftment and survival after umbilical cord blood transplant in adults. Br J Haematol. 2007 Nov;139(3):464-74. doi: 10.1111/j.1365-2141.2007.06824.x. PMID 17910637
- DERIVEDKindwall-Keller TL, Hegerfeldt Y, Meyerson HJ, Margevicius S, Fu P, van Heeckeren W, Lazarus HM, Cooper BW, Gerson SL, Barr P, Tse WW, Curtis C, Fanning LR, Creger RJ, Carlson-Barko JM, Laughlin MJ. Prospective study of one- vs two-unit umbilical cord blood transplantation following reduced intensity conditioning in adults with hematological malignancies. Bone Marrow Transplant. 2012 Jul;47(7):924-33. doi: 10.1038/bmt.2011.195. Epub 2011 Oct 17. PMID 22002488
- DERIVEDWeitzel RP, Lesniewski ML, Haviernik P, Kadereit S, Leahy P, Greco NJ, Laughlin MJ. microRNA 184 regulates expression of NFAT1 in umbilical cord blood CD4+ T cells. Blood. 2009 Jun 25;113(26):6648-57. doi: 10.1182/blood-2008-09-181156. Epub 2009 Mar 13. PMID 19286996