Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02648932
Recruitment Status : Active, not recruiting
First Posted : January 7, 2016
Last Update Posted : October 9, 2019
Sponsor:
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia (AML) Myelodysplastic Syndrome (MDS) Biological: Haplo-Cord Transplant Procedure: Matched Unrelated Donor Transplant Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Rapid Study: Randomized (RA) Phase (P) II Study To Expedite Allogeneic Transplant With Immediate (I) Haploidentical Plus Unrelated Cord Donor (D) Search Versus Matched Unrelated Donor Search For AML And High-Risk MDS Patients
Actual Study Start Date : February 4, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Haplo-Cord Search
If subject meets the inclusion criteria and consents, will undergo a haplo-cord transplant.
Biological: Haplo-Cord Transplant
For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device

Matched Unrelated Donor Search (MUD)
If subject meets the inclusion criteria and consents, will undergo a MUD transplant.
Procedure: Matched Unrelated Donor Transplant



Primary Outcome Measures :
  1. Time to Transplant [ Time Frame: 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 :
  1. Percentage of patients who undergo hematopoietic cell transplantation (HCT) [ Time Frame: Through one year after formal search ]
    Compare percentage of patients who undergo HCT in each study cohort

  2. Survival time [ Time Frame: From date of randomization up to 3 years ]
    Evaluate overall survival time to randomization by study cohort computed using the Kaplan-Meier estimate



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for Search Phase:

  1. Diagnosis of acute myeloid leukemia (AML) or high or very high-risk MDS by international prognostic scoring system revised for whom transplant is recommended
  2. 18 years of age or older
  3. 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).
  4. 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)
  5. Ability to understand and the willingness to sign a written informed consent document for the Search Phase.
  6. Patient willing to consider HCT
  7. A preliminary search has identified:

    1. 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
    2. At least one potential 8/8 HLA-matched (HLA-A, -B, -C, and -DRB1) unrelated donor with a probability of 70% AND
    3. Availability of a potential related haploidentical donor.

Exclusion Criteria for Search Phase:

  1. Prior formal search was instituted
  2. Diagnosis of acute promyelocytic leukemia (APL)
  3. Known HLA matched related donor without contraindications to donate
  4. Life expectancy severely limited by concomitant illness or uncontrolled infection

Inclusion Criteria for Transplant Phase

  1. 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.
  2. For MDS. IPSS-revised criteria of high or very high at diagnosis.
  3. Subject meets institutional criteria for transplant and has acceptable organ and marrow function as defined below:

    1. Serum bilirubin < 2.0mg/dL unless Gilberts disease
    2. Creatinine Clearance > 45 mL/min.1.73m2 as estimated by modified MDRD equation
    3. Left ventricular function 40% or greater
    4. DLCO corrected for hemoglobin >50%
    5. KPS 70% or greater
  4. An adequate graft for the defined donor type

    1. 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.
    2. 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.
  5. Written informed consent for the transplant phase

Exclusion Criteria for Transplant Phase

  1. Life expectancy severely limited by concomitant illness or uncontrolled infection
  2. HIV-positive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648932


Locations
Layout table for location information
United States, Illinois
University of Chicago Cancer Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Layout table for investigator information
Principal Investigator: Andrew Artz, MD University of Chicago

Layout table for additonal information
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02648932    
Other Study ID Numbers: IRB15-0866
First Posted: January 7, 2016    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Keywords provided by University of Chicago:
Acute Myeloid Leukemia (AML)
High-Risk Myelodysplastic Syndrome (MDS)
hematopoietic cell transplantation
haplo-cord search
matched unrelated donor search
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Preleukemia
Myelodysplastic Syndromes
Leukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions