NCT01810588CompletedPhase 2
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation
A Prospective Study of Optimal Cord Selection for Haplo-Cord Transplantation: Targeting the Inherited Paternal Antigen (IPA) and Matching for the Non-Inherited Maternal Antigen (NIMA)
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
In this trial, we aim to improve the outcomes of haplo cord transplant. Haplo cord transplant is a novel and promising way to improve transplant outcomes. We hypothesize that identification of a graft that is at least 5/6 matched and inherited paternal antigen (IPA) targeted (i.e., cord blood grafts share one or more IPA antigens with the prospective recipient) is more important to the outcome of haplo cord transplant than the nucleated cell dose. The identification of such a graft for a large proportion of the subjects may necessitate accepting a lower umbilical cord graft dose. In addition to a umbilical cord blood transplant, recipients will receive stem cells from a family member ( a haplo-identical donor) . After collection and prior to infusion, these cells will be purified using a device called a CliniMACS CD34 selection device. The subject will undergo a chemotherapy conditioning regimen prior to transplantation. No experimental drugs are used in this study, and the combinations of drugs that will be used in the conditioning regimen are combinations that have been used in the past.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 270 (actual)
- First submitted
- 7 Jan 2013
- Start date
- 16 Oct 2012
- Primary completion date
- 9 Aug 2023
- Lead sponsor
- Weill Medical College of Cornell University
- NCT number
- NCT01810588
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 270
- From 16 Oct 2012 to the primary completion date, 9 Aug 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Life expectancy is severely limited by concomitant illness or uncontrolled infection
Other illness
- Evidence of chronic active hepatitis or cirrhosis
- Uncontrolled HIV disease
Lab values
- Severely decreased Left Ventricular Ejection Fraction (LVEF) or impaired pulmonary function tests (PFT's)
Other
- Pregnant or lactating
Who the study is looking for
- Subject must have a confirmed diagnosis of:
- Previously Relapsed or refractory acute leukemia (myeloid or lymphoid)
- Acute leukemia in first remission at high-risk for recurrence
- Chronic myelogenous leukemia in chronic, accelerated phase or blast-crisis
- Recurrent or refractory malignant lymphoma or Hodgkin lymphoma
- Chronic lymphocytic leukemia, relapsed or with poor prognostic features
- Multiple myeloma
- Myelodysplastic syndrome
- Chronic myeloproliferative disease
- Hemoglobinopathies
- Aplastic anemia
- Other hematological disorder in need of allogeneic transplant (e.g. blastoid dendritic cell neoplasm)
- Age ≥ 18 years
- Likely to benefit from allogeneic transplant in the opinion of the transplant physician
- An HLA-identical related or unrelated donor cannot be identified within an appropriate time frame.
- Karnofsky (KPS) Performance status of \>= 70%
- Acceptable organ function as defined below: Serum bilirubin: \< 2.0mg/dL ALT(SGPT): \< 3 X upper limit of normal Creatinine Clearance: \> 50 mL/min/1.73m2 (as estimated by the modified MDRD equation)
- Ability to understand and the willingness to sign a written informed consent document
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.