Clinical trial · Interventional
Hematopoietic Stem Cell Transplantation (HSCT) Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
Phase II Study: HSCT Using CD34 Selected Mismatched Related Donor and One Umbilical Cord Unit
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Only one patient was enrolled. Due to low accrual study was terminated
Summary
Brief summary (as posted)
This study is a means of providing transplantation to those patients who would be a stem cell transplant candidate who do not have an appropriate donor. The use of CD34 selected haploidentical donor with an umbilical cord unit may help provide earlier engraftment without the need for long term immunosuppression. This study tests a new method of bone marrow transplantation called combined haploidentical-cord blood transplantation. In this procedure, some of the blood forming cells (the stem cells) from a partially human leukocyte antigen (HLA) matched (haploidentical) related donor are collected from the blood, as well as cells from an umbilical cord are transplanted into the patient (the recipient) after administration of a "conditioning regimen". A conditioning regimen consists of chemotherapy and sometimes radiation to the entire body (total body irradiation, or TBI), which is meant to destroy the cancer cells and suppress the recipient's immune system to allow the transplanted cells to take (grow).
Conditions
Conditions (6)
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, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Lymphocytic, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myelocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Leukemia, Myeloid, Chronic | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Hodgkins | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoma, Non-Hodgkin | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Haploidentical/cord transplant | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Haploidentical/cord transplant
- description
- Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.
- interventionNames
- Biological: Haploidentical/cord transplant
Primary outcomes (1)
- measure
- The Primary Objective is to Estimate the Overall Survival, Separately in the Two Risk Strata.
- timeFrame
- 3 years
Secondary outcomes (6)
- measure
- Time to Relapse: To Assess the Incidence of Acute Leukemia or Lymphoma Relapse From Day of Transplant
- timeFrame
- 2 years
- description
- NOT analyzed since there was only patient and no relapse was observed till patient passed away
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients between 18 and 65 years old * Patient has a related family member(haploidentical) or unrelated which is 5 of 10 HLA identical match. Standard Risk * Acute myelogenous leukemia: CR1 with high risk cytogenetics or molecular abnormalities such as FLT-3 ITD, or CR2 with a first remission that must have lasted \> 1 year. * Acute Lymphocytic Leukemia: CR1, in order to be standard risk must NOT have Philadelphia Chromosome. * Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): Must be refractory to fludarabine or fail to have a complete or partial response after therapy with a regimen containing fludarabine (or another nucleoside analog, e.g. 2-CDA, pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing fludarabine (or another nucleoside analog). * Chronic myelogenous leukemia: resistant to or intolerant of TKI, in CP1 or CP2, or with a mutation that suggests resistance to TKI. * Myelodysplastic Syndrome: RA, RARS, must be IPSS ≥ INT-2, Blasts \<5%. High Risk Patients: * Acute myelogenous leukemia: Patients with CR2 are considered high risk if they have high risk cytogenetics, or molecular abnormalities or CR1 lasted for less than 1 year. Any evidence of active disease or no blasts in an acellular marrow. * Acute Lymphocytic Leukemia: CR1- with Ph+ disease, CR2/+ with any cytogenetics. Any evidence of active disease. * Chronic myelogenous leukemia- CP2/+, AP1/+, resistant or intolerant to TKI. * Hodgkin's or Non Hodgkin's lymphoma- Disease recurrence following an autologous transplant, or high risk disease not thought to benefit from autologous transplant. * Chronic lymphocytic leukemia- that is resistant to fludarabine, and never has been in remission or with stable disease/progressive disease * Multiple myeloma: Must have had prior treatment. Patients in CR2 or greater can be considered, must have already failed autologous transplant Previous autologous transplant,must have been greater than 6 months prior to undergoing this transplant. * Myelodysplastic syndrome: RAEB * Other Myeloproliferative disorders including myelofibrosis, spent phase p Vera,Essential thrombocytosis,CMML. Exclusion Criteria: * Patients \<18 years old Disease related criteria * APML, presence of t(15,17) in first CR * Patients with good risk AML, for example t(8;21), or inv 16, or normal cytogenetics with FLT-3-ITD negative, NPM-1 positive disease in 1st CR * MDS IPSS \< INT-2 Miscellaneous Criteria * Recipients who have a matched related sibling or unrelated donor * If recipient has evidence of anti-HLA antibodies directed against cord or haplo-donor as determined byflowPRA. Underlying health criteria: * Zubrod performance status \> 2 (see Appendix E) * Life expectancy is limited to less than 8 weeks by concomitant illness * Patients with severely decreased LVEF (EF \< 40%) * Impaired pulmonary function tests (PFT's) (FVC, FEV1, DLCO \< 45% predicted) * Estimated Creatinine Clearance \<50 ml/min * Serum bilirubin\> 2.0 mg/dl or SGPT \>3 x upper limit of normal * Evidence of chronic active hepatitis or cirrhosis * HIV-positive * Patient is pregnant * Patient or guardian not able to provide informed consent
References
Publications (1)
- DERIVEDvan Besien K, Artz A, Champlin RE, Guarneri D, Bishop MR, Chen J, Gergis U, Shore T, Liu H, Rondon G, Mayer SA, Srour SA, Stock W, Ciurea SO. Haploidentical vs haplo-cord transplant in adults under 60 years receiving fludarabine and melphalan conditioning. Blood Adv. 2019 Jun 25;3(12):1858-1867. doi: 10.1182/bloodadvances.2019000200. PMID 31217161