Cord Blood Transplant in Adults With Blood Cancers

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorMemorial Sloan Kettering Cancer Center

About this trial

Cord blood transplants (CBT) are a standard treatment for adults with blood cancers. MSK has developed a standard ("optimized") practice for cord blood transplant (CBT). This optimized practice includes how patients are evaluated for transplant, the conditioning treatment (standard chemotherapy and total body irradiation therapy) given to prepare the body for transplant, the amount of stem cells transplanted, and how patients are followed during and after transplant.The purpose of this study is to collect information about participant outcomes after CBT following MSK's optimized practice. The researchers will look at outcomes of the CBT treatment such as side effects, disease relapse, GVHD, and immune system recovery after CBT treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Therapy-related AML.

Presence of extramedullary leukemia at diagnosis.

Requirement for 2 or more inductions to achieve CR1.

Disqualifiers

Diagnosis of myelofibrosis or other malignancy with moderate-severe bone marrow fibrosis.

Patients with persistent with CNS involvement in CSF or CNS disease at time of screening

Prior checkpoint inhibitors/ blockade in the last 12 months.

Two prior stem cell transplants of any kind.

Trial design

Design model

Single group

Treatments tested in this trial

  • Conditioning Chemotherapy

    Drug

    Conditioning: Cyclophosphamide (CY) 50 mg/kg x1 (day -6), Fludarabine (FLU) 30 mg/m2 x5 (days -6 to -2), Thiotepa (THIO) 5 mg/kg x2 (days -5 \& -4), Total Body Irradiation (TBI) 200 cGy x2 (days -2 \& -1). GVHD prophylaxis: Cyclosporine (CSA) 3 mg/kg q12 hours \& Mycophenolate Mofetil (MMF) 15 mg/kg q8 hours (starting IV day -3).

  • Cord blood graft

    Biological/Vaccine

    The double-unit CB graft will be infused on day 0 per standard practice.

Treatment groups

54 Participants
are divided into 1 treatment group
Group A: Cord Blood TransplantExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

Time frame
1 year post transplant

Secondary outcomes

1

Time to neutrophil engraftment

The day of neutrophil recovery is the 1st day of 3 consecutive days of absolute neutrophil count (ANC) at or above 500 after the first post-CBT nadir.

Time frame
Up to day 45 post-transplant

Other outcomes

Sponsors and contacts

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