Umbilical Cord Blood Transplantation In Patients With Hematologic Malignancies Using A Myeloablative Preparative Regimen

Completed · Phase 2

Conditions studied: Hematologic Malignancies, Disorder Related to Transplantation, Hematopoietic Malignancy

In brief

In this study, participants with high-risk hematologic malignancies undergoing hematopoietic cell transplantation (HCT), who do not have a suitable human leukocyte antigen (HLA)-matched related/sibling donor (MSD), matched unrelated donor (MURD) or killer-immunoglobulin receptors (KIR) ligand mismatched haploidentical donor identified, will receive an umbilical cord blood transplantation (UCBT) using a myeloablative preparative regimen. The preparative regimen includes fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (10.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2. Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1.

Key facts

Study ID: NCT01328496
Run by: St. Jude Children's Research Hospital
People needed: 14
Starts: 2011-06-15
Expected to finish: 2016-10-31
Last updated by the study team: 2017-06-05

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age less than or equal to 21 years old.
Has a partially HLA-matched single or double UCB product
High-risk hematologic malignancy.
High risk ALL in CR1, ALL in High risk CR2, ALL in CR3 or subsequent.
AML in high risk CR1, AML in CR2 or subsequent
AML in first relapse with < 25% blasts in BM
Therapy related AML, with prior malignancy in CR > 12mo
MDS, primary or secondary
NK cell, biphenotypic, or undifferentiated leukemia in CR1 or subsequent.
CML in accelerated phase, or in chronic phase with persistent molecular positivity or intolerance to tyrosine kinase inhibitor.
Hodgkin lymphoma in CR2 or subsequent after failure of prior autologous HCT, or unable to mobilize stem cells for autologous HCT.
Non-Hodgkin lymphoma in CR2 or subsequent after failure of prior autologous HCT, or unable to mobilize stem cells for autologous HCT.
JMML
All patients with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for study.
Patient must fulfill pre-transplant evaluation:
Cardiac shortening fraction ≥ 26%.
Creatinine clearance ≥ 70 ml/min/1.73m2.
Forced vital capacity (FVC) ≥ 50% of predicted value or pulse oximetry ≥ 92% on room air.
Karnofsky (≥ 16 years) or Lansky (<16 years) performance score ≥ 70
Bilirubin ≤ 2.5 mg/dL.
Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age.
Aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age.

You may not qualify if…

Patient has a suitable MSD, volunteer MURD, or KIR mismatched haploidentical donor available in the necessary time for stem cell donation.
Patient has any other active malignancy other than the one for which HCT is indicated.
Patient had a prior allogeneic HCT
Patient had an autologous HCT within the previous 12 months.
Patient is pregnant as confirmed by positive serum or urine pregnancy test within 14 days prior to enrollment.
Patient is lactating
Patient has Down Syndrome
Patient has a current uncontrolled bacterial, fungal, or viral infection per the judgment of the PI.

Where it is running

St. Jude Children's Research Hospital — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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