Cord Blood Transplantation in Children and Young Adults With Blood Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeUp to 26
SponsorMemorial Sloan Kettering Cancer Center

About this trial

The purpose of this study is to find out whether Cord Blood Transplantation/CBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Known prior diagnosis of myelodysplasia (MDS)

High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and/or high-risk molecular abnormalities (e.g., TP53)

Requirement for 2 or more inductions to achieve CR1

Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and/or gene therapy or cell therapy)

Disqualifiers

Chloroma >2 cm.

Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.

HIV infection.

Seropositivity for HTLV-1.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cord Blood Units

    Biological/Vaccine

    Cord Blood \[(HPC(CB)\] products are minimally manipulated unrelated allogeneic cord blood units that have been collected, processed and stored in public Cord Blood banks

  • Total Body Irradiation

    Radiation

    Hyper-fractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Treatment planning begins with simulation.

  • Cyclophosphamide

    Drug

    Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis.

  • Fludarabine

    Drug

    Fludarabine phosphate is rapidly dephosphorylated to 2- fluoro-ara- A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2- fluoro-ara-ATP

  • Clofarabine

    Drug

    Clofarabine, a purine (deoxyadenosine) nucleoside analog, is metabolized to clofarabine 5'-triphosphate.

  • Busulfan

    Drug

    Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate.

  • Thiotepa

    Drug

    Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.

  • Tacrolimus

    Drug

    Tacrolimus inhibits T-lymphocyte activation

  • Mycophenolate Mofetil

    Drug

    Mycophenolate exhibits a cytostatic effect on T and B lymphocytes.

  • Cyclosporine

    Drug

    Cyclosporine is a calcineurin inhibitor that inhibits production and release of interleukin II and inhibits interleukin II-induced activation of resting T-lymphocytes.

Treatment groups

71 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Patients with High-Risk DiseaseExperimental treatment 10 interventions
Group B: Cohort 2: Patients with Very High-Risk DiseaseExperimental treatment 10 interventions

Trial outcomes

Primary outcomes

1

Disease-free Survival (DFS)

Disease-free Survival (DFS) at 1 year after CBT

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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