Clinical trial · Interventional
Donor Umbilical Cord Blood Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
Unrelated Umbilical Cord Blood As An Alternate Source Of Stem Cells Transplantation
- 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 be able to replace immune cells that were destroyed by the chemotherapy or radiation therapy that was used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of allogeneic umbilical cord blood transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
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 |
| Myelodysplastic-Myeloproliferative Diseases | Myelodysplastic/Myeloproliferative Neoplasm | ALIAS | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-thymocyte globulin | Biological | — | UNRESOLVED |
| busulfan | Drug | Busulfan | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cyclosporine | Drug | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| fludarabine phosphate | Drug | Fludarabine | ALIAS |
| melphalan | Drug | Melphalan | ALIAS |
| methylprednisolone | Drug | — | UNRESOLVED |
| radiation therapy |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of 1 of the following hematologic malignancies:
* Acute myeloid leukemia (AML)\*
* With or without history of myelodysplastic syndromes (MDS)
* Patients in first complete remission (CR) (no greater than 5% blasts in marrow) with translocations t(8;21) and inv(16) are allowed provided they failed first-line induction therapy
* Patients in first CR (no greater than 5% blasts in marrow) with translocations t(15;17) are allowed provided at least 1 of the following is true:
* Failed first-line induction therapy
* Molecular evidence of persistent disease
* No patients in first CR and with Down syndrome
* Acute lymphoblastic leukemia (ALL)\*, meeting 1 of the following criteria:
* Not in first CR (no greater than 5% blasts in marrow)
* In first CR and high risk as defined by 1 of the following:
* Hypoploidy (no more than 44 chromosomes)
* Pseudodiploidy with translocations or molecular evidence of t(9;22), 11q23, or t(8;14) (excluding B-ALL) or +MLL gene rearrangement
* One of the following elevated WBC levels:
* WBC greater than 100,000/mm\^3 if 6 to 12 months of age
* WBC greater than 200,000/mm\^3 if between 10 and 17 years of age
* WBC greater than 20,000/mm\^3 if 18 years of age and over (adult \[over 18 years of age\] patient stratum closed to accrual)
* Failed to achieve CR after 4 weeks of induction therapy
* B-ALL that is not in first CR or that meets at least 1 of the high-risk criteria specified above
* No translocation t(8;14)
* No blasts with surface immunoglobulins
* CD10 negative
* Undifferentiated leukemia\*
* Infant leukemia\*
* Biphenotypic leukemia\*
* Chronic myelogenous leukemia, meeting 1 of the following criteria:
* Accelerated phase
* Chronic phase
* At least 1 year from diagnosis without an identified matched unrelated bone marrow donor AND unresponsive to or unable to tolerate interferon
* Blast crisis\* (greater than 30% promyelocytes plus blasts in the marrow)
* One of the following MDS:
* Refractory anemia
* Refractory anemia with ringed sideroblasts
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* Paroxysmal nocturnal hemoglobinuria
* Hodgkin's or non-Hodgkin's lymphoma beyond first CR or failed primary induction therapy
* Tumor displays chemosensitivity (greater than 50% reduction in mass size after the most recent therapy) NOTE: \*Patients in third or greater medullary relapse or refractory disease (other than primary induction failures) or blast crisis receive the study busulfan/melphalan conditioning regimen)
OR
* Diagnosis of one of the following nonmalignant diseases :
* Acquired severe aplastic anemia (stratum closed to accrual)
* Unresponsive to medical therapy with anti-thymocyte globulin and/or cyclosporine
* Inborn errors of metabolism, including, but not limited to the following:
* Hurler's syndrome
* Adrenoleukodystrophy
* Maroteaux-Lamy syndrome
* Globoid cell leukodystrophy
* Metachromatic leukodystrophy
* Fucosidosis
* Mannosidosis
* Fanconi anemia documented by increased chromosomal fragility assays and meeting 1 of the following criteria (stratum closed to accrual):
* Severe pancytopenia
* Absolute neutrophil count less than 500/mm\^3
* Platelet count less than 20,000/mm\^3
* Hemoglobin less than 8 g/dL
* Morphologic evidence of MDS with clonal chromosomal abnormalities
* Leukemia transformation
* Other marrow failure syndromes, including any of the following (stratum closed to accrual):
* Blackfan-Diamond syndrome that is unresponsive to medical therapy
* Kostmann's congenital agranulocytosis unresponsive to medical therapy
* Congenital amegakaryocytic thrombocytopenia
* Thrombocytopenia absent radius
* Combined immune deficiencies including, but not limited to the following:
* Severe combined immunodeficiency (SCID)
* Wiskott-Aldrich syndrome
* Leukocyte adhesion defect
* Chediak-Higashi disease
* X-linked lymphoproliferative disease
* Adenosine deaminase deficiency
* Purine nucleoside phosphorylase deficiency
* X-linked SCID
* Common variable immune deficiency
* Nezeloff's syndrome
* Cartilage hair hypoplasia
* Reticular dysgenesis
* No active CNS leukemia (cerebrospinal fluid with WBC greater than 5/mm\^3 and malignant cells on cytospin)
* No SCID patients who do not require cytoreduction
* No dyskeratosis congenita
* No primary myelofibrosis
* No grade 3 or greater myelofibrosis
* Familial erythrophagocytic lymphohistiocytosis patients must not have any of the following:
* Abnormal brain MRI
* Neurologic symptoms
* Lymphocytes and monocytes greater than 7/mm\^3 in the cerebrospinal fluid
* No available 5/6 or 6/6 HLA-matched related donor
PATIENT CHARACTERISTICS:
Age
* 55 and under (over 18 closed to accrual)
Performance status
* Karnofsky 70-100% OR
* Lansky 50-100% (patients under 16 years old)
Life expectancy
* Not specified
Hematopoietic
* See Disease Characteristics
Hepatic
* SGOT less than 5 times upper limit of normal
* Bilirubin less than 2.5 mg/dL
Renal
* Creatinine normal for age OR
* Creatinine clearance or glomerular filtration rate greater than 50% of lower limit of normal
Cardiovascular
* LVEF greater than 40% at rest and must improve with exercise\* OR
* Shortening fraction greater than 26%\* NOTE: \*If symptomatic
Pulmonary
* DLCO greater than 45% of predicted\* (corrected for hemoglobin)
* FEV\_1 and FEC greater than 45% of predicted (corrected for hemoglobin) OR
* Room air oxygen saturation greater than 85%\* NOTE: \*If symptomatic
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No uncontrolled viral, bacterial, or fungal infection
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
* More than 12 months since prior allogeneic stem cell transplantation with cytoreductive preparative therapy
* More than 6 months since prior autologous stem cell transplantation
Chemotherapy
* See Biologic therapy
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* No prior enrollment on this study
* No continuous life support (e.g., mechanical ventilation) within 1 year after study transplantation (for patients with inborn errors of metabolism)References
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