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Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders

ConditionsAMLALLMDSMPD Withou MyelofibrosisNHL or HLInherited Metabolic DisordersHemoglobinopathiesBone Marrow FailureHLH
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorMemorial Sloan Kettering Cancer Center

About this trial

This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPS).

Therapy-related AML (t-AML).

White cell count at presentation > 100,000.

Presence of extramedullary leukemia at diagnosis.

Disqualifiers

Inadequate performance status/ organ function.

Advanced metabolic disease (EBMT handbook).

Active CNS leukemic involvement.

Indolent NHL or Hodgkin lymphoma with progression of disease after most recent salvage chemotherapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clofarabine

    Drug

    Clofarabine

  • Fludarabine

    Drug

    Fludarabine

  • Busulfan

    Drug

    Busulfan per PK

  • Cyclosporine-A

    Drug

    GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.

  • Mycophenolate Mofetil

    Drug

    GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.

  • Cord Blood Graft

    Biological/Vaccine

    The CB graft will be infused on day 0 per standard practice

Treatment groups

31 Participants
are divided into 2 treatment groups
Group A: Participants with malignant hematologic disordersExperimental treatment 6 interventions
Group B: Participants with non-malignant hematologic disordersExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Treatment related mortality at 1 year after myeloablative cord transplant

The primary objective of this study is to assess treatment related mortality (TRM) at 1 year after myeloablative cord transplant.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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