The Rapid Study: Randomized Phase II Study To Expedite Allogeneic Transplant With Immediate Haploidentical Plus Unrelated Cord Donor Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients

NCT02648932 | Terminated Phase 2 Results

• 1 other identifier: IRB15-0866
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to compare time from formal search to hematopoietic cell transplantation (HCT) for patients 18 years and older, randomized between haplo-cord search and matched unrelated donor (MUD) search for patients with acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS)

Conditions

Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Keywords

Acute Myeloid Leukemia (AML); High-Risk Myelodysplastic Syndrome (MDS); hematopoietic cell transplantation; haplo-cord search; matched unrelated donor search

Outcome Measures

Primary Outcomes (1)

• Time to Transplant

  Time to transplant will be measured from time of date of formal request to stem cell infusion date. Will also capture time from preliminary search to both formal search and transplant date.

  Through one year after formal search

Secondary Outcomes (2)

• Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)

  Through one year after formal search

• Estimated Survival Time

  From date of randomization up to 3 years

Study Arms (2)

Haplo-Cord Search

OTHER

If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.

Biological: Haplo-Cord Transplant

Matched Unrelated Donor Search (MUD)

OTHER

If subject meets the inclusion criteria and consents, will undergo a MUD transplant.

Procedure: Matched Unrelated Donor Transplant

Interventions

Haplo-Cord Transplant BIOLOGICAL

For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device

Haplo-Cord Search

Matched Unrelated Donor Transplant PROCEDURE

Matched Unrelated Donor Search (MUD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute myeloid leukemia (AML) or high or very high-risk MDS by international prognostic scoring system revised for whom transplant is recommended
• years of age or older
• Subject is likely to be considered for allogeneic transplant in the opinion of the transplant physician (based on age of patient, health, cytogenetics, and/or molecular characteristics).
• Karnofsky Performance Status (KPS) \>/= 70% at time of enrollment. An exception will be made for those with lower KPS at enrollment with an acute worsening that is likely to resolve in the treating physicians judgment (e.g., reversible infection,trauma, medication reaction, etc)
• Ability to understand and the willingness to sign a written informed consent document for the Search Phase.
• Patient willing to consider HCT
• A preliminary search has identified:
• An appropriate minimum 4/6 matched umbilical cord unit at intermediate resolution at HLA-A and B, and high resolution at HLA-DRB with a cell dose above 1 x 10(7) TNC/kg for a single umbilical cord blood (UCB) transplant AND
• At least one potential 8/8 HLA-matched (HLA-A, -B, -C, and -DRB1) unrelated donor with a probability of 70% AND
• Availability of a potential related haploidentical donor.

You may not qualify if:

• Prior formal search was instituted
• Diagnosis of acute promyelocytic leukemia (APL)
• Known HLA matched related donor without contraindications to donate
• Life expectancy severely limited by concomitant illness or uncontrolled infection
• High-risk AML for which transplant is recommend based on cytogenetic, molecular and morphologic features. Patients must meet institutional standards for disease control prior to transplant.
• For MDS. IPSS-revised criteria of high or very high at diagnosis.
• Subject meets institutional criteria for transplant and has acceptable organ and marrow function as defined below:
• Serum bilirubin \< 2.0mg/dL unless Gilberts disease
• Creatinine Clearance \> 45 mL/min.1.73m2 as estimated by modified MDRD equation
• Left ventricular function 40% or greater
• DLCO corrected for hemoglobin \>50%
• KPS 70% or greater
• An adequate graft for the defined donor type
• Haplo-cord requires a haploidentical adult donor of 14 years of age and at least 50 kg, and a cord blood unit with at least 1.0 x 10(7) TNC/kg and a match of at least 4/6 by intermediate resolution for HLA-A and B and high resolution at DRB1. Donor provides standard of care consent for harvest following institutional policy. Any donor samples or donor research data would be obtained on separate donor research protocol.
• For MUD requires a 7/8 or 8/8 HLA matched unrelated donor with high resolution matching at HLA-A, -B, -C, and DRB1. DP matching or DP permissive should be achieved when possible using T-cell epitope strategy.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Results Point of Contact

• Title: Hongtao Liu
• Organization: University of Chicago

hliu2@medicine.bsd.uchicago.edu

773-834-0589

Study Officials

• Andrew Artz, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 7, 2016
• Study Start: February 4, 2016
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-02

Locations

US (1)