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Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

Primary Purpose

Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Geriatric assessment (GA) pre-transplant
conditioning regimen
Allogeneic CD34+ selected stem cells
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • are 60 years or older
  • have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome
  • have <10% blasts in bone marrow prior to transplant
  • have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor
  • Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician

Exclusion Criteria:

  • Prior hematopoietic cell transplantation
  • Cord blood donors
  • Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Consent Only)Recruiting
  • Memorial Sloan Kettering Monmouth (Consent Only)Recruiting
  • Memorial Sloan Kettering Bergen (Consent Only)Recruiting
  • Memorial Sloan Kettering Commack (Consent only)Recruiting
  • Memorial Sloan Kettering Westchester (Consent Only)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Consent Only)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Geriatric participants with various blood disorders

Arm Description

Geriatric assessment (GA) pre-transplant Risk-adapted allocation of conditioning intensity based on GA GA-directed, longitudinal supportive care management

Outcomes

Primary Outcome Measures

cumulative incidence of non-relapse mortality (NRM)
defined as death in the absence of relapse/disease progression.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
August 1, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04761770
Brief Title
Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders
Official Title
Phase II Study of a Geriatric Assessment-Driven, Risk-Adapted Allogeneic Hematopoietic Cell Transplant Strategy for Older Patients With Myeloid Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study will evaluate whether a geriatric assessment can lead to better treatment outcomes in older patients (age 60+) with a myeloid malignancy including acute myeloid leukemia, ,myelodysplastic syndromes, myeloproliferative neoplasms, or related blood disorders who are going to receive chemotherapy or another treatment to prepare the body for an allogeneic hematopoietic stem cell transplant (allo-HCT). The geriatric assessment includes looking at patients' cognitive function (thinking processes), physical function, mobility (ability to move the body), mood, nutrition, and current medications to help decide the type of treatment they'll receive. Another purpose of this study is to see whether use of the geriatric assessment improves participants' quality of life. We will evaluate participants' quality of life through questionnaires.
Detailed Description
This is a prospective, phase II study evaluating the efficacy of a risk-adapted, personalized allo-HCT strategy based on geriatric vulnerabilities identified by pre-transplant GA. The less vulnerable/fit older patients are recommended to receive MA conditioning and the more vulnerable older patients are recommended to receive RIC/NMA conditioning. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> MA regimen HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> RIC/NMA regimen Chemotherapies: busulfan, fludarabine, melphalan, cyclophosphamide, thiotepa, clofarabine Radiation therapy: total body irradiation (TBI) Other therapy: anti-thymocyte globulin (ATG)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome, Myeloproliferative Neoplasms, Chronic Myelomonocytic Leukemia, Atypical Chronic Myeloid Leukemia, Myelodysplastic/Myeloproliferative Overlapping Syndrome
Keywords
blood disorders, Allogeneic Hematopoietic Cell Transplant, 20-522

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
This is a prospective, single center, phase II pilot treatment-allocation study at MSK for older patients considering allogeneic hematopoietic cell transplantation.
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Geriatric participants with various blood disorders
Arm Type
Experimental
Arm Description
Geriatric assessment (GA) pre-transplant Risk-adapted allocation of conditioning intensity based on GA GA-directed, longitudinal supportive care management
Intervention Type
Other
Intervention Name(s)
Geriatric assessment (GA) pre-transplant
Intervention Description
Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
Intervention Type
Drug
Intervention Name(s)
conditioning regimen
Intervention Description
Based on the Geriatric assessment. HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen
Intervention Type
Procedure
Intervention Name(s)
Allogeneic CD34+ selected stem cells
Intervention Description
Stem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual.
Primary Outcome Measure Information:
Title
cumulative incidence of non-relapse mortality (NRM)
Description
defined as death in the absence of relapse/disease progression.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are 60 years or older have a pathologically confirmed myeloid malignancies including acute myeloid leukemia, ,myelodysplastic syndrome, myeloproliferative neoplasms, or related blood disorders including chronic myelomonocytic leukemia, atypical chronic myeloid leukemia, and myelodysplastic/myeloproliferative overlapping syndrome have <10% blasts in bone marrow prior to transplant have a matched related or unrelated donor, mismatched unrelated donor, or haploidentical donor Meet institutional standard criteria for allogeneic transplantation as determined by the primary transplant physician Exclusion Criteria: Prior hematopoietic cell transplantation Cord blood donors Persons with active, refractory disease defined by ≥10% blasts in bone marrow prior to transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Email
ABMTTrials@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Roni Tamari, MD
Phone
646-608-3738
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Consent Only)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Facility Name
Memorial Sloan Kettering Monmouth (Consent Only)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Facility Name
Memorial Sloan Kettering Bergen (Consent Only)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Facility Name
Memorial Sloan Kettering Commack (Consent only)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Facility Name
Memorial Sloan Kettering Westchester (Consent Only)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard j Lin, MD, PhD
Phone
646-608-2646
Email
ABMTTrials@mskcc.org
Facility Name
Memorial Sloan Kettering Nassau (Consent Only)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard J Lin, MD, PhD
Phone
646-608-2646

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

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Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders

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