UnknownPhase 2

Phase II Study of Myeloablative Double Unit Umbilical Cord Blood Transplantation in Adult Patients

39 participantsStarted 2015-04

Plain-language summary

This study aimed to evaluate the efficacy and safety of myeloablative double unit umbilical cord blood transplantation (dUCBT) in adult patients with hematologic malignancies. Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI), cyclophosphamide, and cytarabine, or (2) thiotepa, busulfan, and fludarabine.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with hematologic malignancies requiring hematopoietic stem cell transplantation: (1) high risk acute myeloid leukemia in remission, (2) high risk acute lymphoblastic leukemia in remission, or (3) IPSS intermediate-2, high, or transfusion-dependent myelodysplastic syndrome * Patients who have suitable cord blood units for dUCBT * Patients with ECOG performance status 0-1 * Patients with adequate organ function: lung, kidney, liver, heart, etc. * Informed consent Exclusion Criteria: * Patients who can receive hematopoietic stem cell transplantation from HLA-matched sibling or unrelated donors * Patients who have anti-HLA antibodies * Patients with any evidence of central nervous system (CNS) involvement of disease * Patients with uncontrolled diabetes * Patients with uncontrolled hypertension * Patients with any evidence of active infection * Positive for human immunodeficiency virus (HIV) * Previous history of other malignancy within 5 years (Basal cell carcinoma of skin, cervical carcinoma in situ, and differentiated thyroid carcinoma with curative resection are permitted.) * Women who are pregnant or breastfeeding * Patients with previous history of allogeneic stem cell transplantation * Patients with major psychotic disorder or drug/alcohol abuser * Inappropriate patients according to the investigators' opinion

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

Timeframe: 2 years

Trial details

NCT IDNCT02385955

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04

Contact for this trial

Sung-Soo Yoon, MD, PhD

+82-2-2072-3079 ssysmc@snu.ac.kr

View on ClinicalTrials.gov More Hematologic Malignancy trials