Lab-Grown stem cells could speed immune recovery in blood cancer transplants
NCT ID NCT03399773
First seen Jul 10, 2026 ยท Last updated Jul 10, 2026
Summary
This phase 2 trial tests whether adding lab-grown umbilical cord blood cells (dilanubicel) to a standard cord blood transplant helps people with blood cancers like leukemia recover their blood and immune cells faster. Participants receive chemotherapy and radiation to prepare their body, then the transplant. The goal is to see if this approach reduces infections and other complications after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dilanubicel (lab-grown umbilical cord blood stem cells)
- What this could lead to
- If it works, this approach could help patients with blood cancer recover their immune system faster after a cord blood transplant, reducing infections and complications.
- What could go wrong
- This is an early-phase pilot study with a small number of participants. The treatment involves strong chemotherapy and radiation, which carry serious risks like infection, organ damage, and graft-versus-host disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
31 people
The number who actually took part.
- Started
-
May 2022
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
10 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients 10 to 65 years old with a hematologic malignancy in need of hematopoietic cell transplant who are \> 30 kg and without a suitable related donor * Patient must have hematologic malignancy that meets institutional eligibility requirements for cord blood transplant * Malignancies included are: * Acute leukemia, including acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL); all patients must be in complete response (CR) as defined by \< 5% blasts by morphology/flow cytometry in a representative bone marrow sample with adequate cellularity to assess remission status * Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)-2 or high risk (i.e., refractory anemia with excess blasts \[RAEB\], refractory anemia with excess blasts in transformation \[RAEBt\]) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be \< 10% in a representative bone marrow aspirate * Chronic myeloid leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy * High dose TBI regimen: 10 to =\< 45 years * Intermediate intensity regimen: 10 to =\< 65 years * Patients 10 to =\< 45 years: Lansky (\< 16 years old) or Karnofsky (\>= 16 years old) \>= 70 or Eastern Cooperative Oncology Group (ECOG) 0-1 * Patients \> 45 to =\< 65 years: Karnofsky \>= 70 or ECOG 0-1 and non-age adjusted comorbidity index =\< 5 * Adults: Calculated creatinine clearance must be \> 60 mL and serum creatinine =\< 2 mg/dL * Children (\< 18 years old): Calculated creatinine clearance must be \> 60 mL/min * Total serum bilirubin must be \< 3 mg/dL unless the elevation is thought to be due to Gilbert's disease or hemolysis * Transaminases must be \< 3 x the upper limit of normal per reference values of treating institution * Carbon monoxide diffusing capability (DLCO) corrected \>= 60% normal (may not be on supplemental oxygen) * For pediatric patients unable to perform pulmonary function tests, O2 saturation \> 92% on room air * Left ventricular ejection fraction \>= 50% OR * Shortening fraction \> 26% * Ability of participant or legally authorized representative to understand and the willingness to sign a written informed consent form * DONOR: Minimum requirement: The cord blood (CB) unit must be matched at a minimum at 4/6 HLA-A, B antigens and DRB1 allele with the recipient; therefore, 0-2 mismatches at the A or B or DRB1 loci based on intermediate resolution at HLA-A, B and high resolution allele level typing at HLA- DRB1 are allowed * DONOR: Institutional guidelines for HLA-match may be followed as long as the minimum criteria for HLA-matching as above are met * DONOR: The CB unit selected for transplant must have a MINIMUM of 2.5 x 10\^7 TNC/kg * DONOR: The minimum recommended CD34/kg cell dose is 1.7 x 10\^5 CD34/kg * DONOR: A backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit. A suitable back up unit will be considered, as follows: * Must be matched at a minimum at 4/6 HLA-A, B, DRBl loci with the recipient. Therefore 0-2 mismatches at the A or B or DRBl loci based on intermediate resolution A, B antigen and DRBl allele typing for determination of HLA-match is allowed (Fred Hutch Protocol 2010). * Must contain a MINIMUM of 1.5 x 10\^7 TNC/kg to ensure the same requirement we use for a standard double CBT per CB selection guideline (Fred Hutch Protocol 2010). Exclusion Criteria: * Uncontrolled viral or bacterial infection at the time of study enrollment * Active or recent (prior 6 month) invasive fungal infection unless cleared by infectious disease (ID) consult * History of human immunodeficiency virus (HIV) infection * Pregnant or breastfeeding * Prior allogeneic transplant * Central nervous system (CNS) leukemic involvement not clearing with intrathecal chemotherapy; diagnostic lumbar puncture is to be performed * \< 30 kg
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
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