Cord Blood Transplantation for Blood Cancer

Recruiting at 6 trial locations

Overseen By Jaap Jan Boelens, MD, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Checkpoint inhibitors

Disqualifiers: Active CNS leukemia, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

Andromachi Scaradavou, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

I developed AML or a myeloid neoplasm after treatment for another cancer or gene/cell therapy.

* Other high-risk features not defined above.

My diagnosis matches the required disease type for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants undergo Cord Blood Transplantation as the first or second transplant

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after transplantation

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cord Blood Transplantation

How Is the Trial Designed?

Group I: Cohort 2: Patients with Very High-Risk Disease + Regimen C Experimental Treatment 10 Interventions

1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.

Group II: Cohort 2: Patients with Very High-Risk Disease + Regimen B Experimental Treatment 10 Interventions

1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.

Group III: Cohort 2: Patients with Very High-Risk Disease + Regimen A Experimental Treatment 10 Interventions

1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.

Group IV: Cohort 1: Patients with High-Risk Disease + Regimen C Experimental Treatment 10 Interventions

Participants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).

Group V: Cohort 1: Patients with High-Risk Disease + Regimen B Experimental Treatment 10 Interventions

Participants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).

Group VI: Cohort 1: Patients with High-Risk Disease + Regimen A Experimental Treatment 10 Interventions

Participants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+