Cord Blood Transplantation in Children and Young Adults With Blood Cancer

Summary

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.

Conditions

• Acute Myelogenous Leukemia
• Acute Lymphoblastic Leukemia
• Myelodysplastic Syndromes
• Non-hodgkin Lymphoma
• Hodgkin Lymphoma
• Leukemia
• Lymphoma
• Graft-versus-host Disease

Interventions

BIOLOGICAL

Cord Blood Units

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

RADIATION

Total Body Irradiation

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

DRUG

Cyclophosphamide

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

DRUG

Fludarabine

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

DRUG

Clofarabine

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

DRUG

Busulfan

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

DRUG

Thiotepa

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.

DRUG

Tacrolimus

Tacrolimus inhibits T-lymphocyte activation

DRUG

Mycophenolate Mofetil

Mycophenolate exhibits a cytostatic effect on T and B lymphocytes.

DRUG

Cyclosporine

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center

  lead OTHER

Principal Investigators

• Andromachi Scaradavou, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

26 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-28

Primary Completion

2030-04-28

Completion

2030-04-28

FDA Drug

Yes

Countries

• United States

Study Locations