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

Phase 2

Terminated

• Conditions: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)
• Interventions: Biological: Haplo-Cord Transplant; Procedure: Matched Unrelated Donor Transplant

• Registration Number: NCT02648932
• Lead Sponsor: University of Chicago

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)

Detailed Description

Primary Objectives

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)

Secondary Objectives

* To compare the percentage of patients who undergo HCT in each study cohort

* To evaluate overall survival from time to randomization by study cohort

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Study Start: 2016-02-04
• Primary Completion: 2020-04
• Study Completion: 2020-04
• Status Verified: 2021-02
• Results First Submitted: 2021-02-22
• Results First Submitted QC: 2021-02-22
• Last Update Submitted: 2021-02-22
• Results First Posted: 2021-03-18
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haplo-Cord Search	Haplo-Cord Transplant	If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Matched Unrelated Donor Search (MUD)	Matched Unrelated Donor Transplant	If subject meets the inclusion criteria and consents, will undergo a MUD transplant.

Primary Outcome Measures

Name	Time	Method
Time to Transplant	Through one year after formal search	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patients Who Undergo Hematopoietic Cell Transplantation (HCT)	Through one year after formal search	Compare percentage of patients who undergo HCT in each study cohort
Estimated Survival Time	From date of randomization up to 3 years	Overall survival time was estimated from date of randomization and from date of transplant using Kaplan-Meier method.

Trial Locations

Locations (1)

University of Chicago Cancer Center; 🇺🇸 Chicago, Illinois, United States