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Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors

Primary Purpose

Acute Myeloid Leukemia (AML)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Induction Chemotherapy
G-PBSC Infusion
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Induction Chemotherapy, G-CSF-Mobilized Stem Cells, Haploidentical Related Donors, 15-141

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 60.
  • Patients with a new diagnosis of histologically confirmed (according to WHO classification 2008) acute myeloid leukemia (either primary or secondary AML) are included.
  • Patients with a diagnosis of myelodysplastic syndrome with >/= 10% bone marrow blasts with no response or progression of disease after at least 4 cycles of a hypomethylating agent (5-azacytiine or decitabine).
  • Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after G-CSF administration.
  • Karnofsky performance status > 70%.
  • Hepatic function - total bilirubin < 2 and, AST < 2.5 x upper limit of normal, unless liver is involved with disease or a history of Gilbert's disease.
  • Renal function - adequate renal function as demonstrated by a serum creatinine <2 mg/dl.
  • LVEF ≥ 50% as determined by echocardiogram or MUGA.
  • Ability to give informed consent.

Donor Eligibility:

  • Donor is blood-related and HLA-haploidentical to the recipient.
  • Donor ≥18 years old
  • Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, and West Nile Virus . Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus.
  • Donor has a CXR and EKG performed.
  • Donor is not allergic to G-CSF.
  • Donor must be able to undergo leukapheresis
  • Donor is not pregnant.
  • Donor does not have concurrent malignancy or autoimmune disease.
  • Ability to give informed consent.

Exclusion Criteria:

  • Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 20080
  • Major surgery or irradiation within two weeks.
  • Previous therapy with cytotoxic agents for AML. Persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or JAK/STAT inhibitors may participate but must have >1 week off therapy prior to enrollment.
  • Active CNS disease.
  • Uncontrolled infection.
  • Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the therapy.
  • Male and female patients of child-bearing potential unwilling to use effective means of contraception.
  • HIV or HTLV I/II seropositivity.
  • Concurrent active malignancy other than AML requiring therapy.
  • Clinically significant cardiac disease (NY Heart Association Class III or IV) or pulmonary disease.
  • Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests

Donor Exclusion:

  • Donor has cardiac risk factors precluding ability to undergo leukapheresis.
  • Donor has evidence of concurrent malignancy or autoimmune disease.
  • Donor is pregnant

Sites / Locations

  • Memorial Sloan Kettering Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells

Arm Description

This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.

Outcomes

Primary Outcome Measures

Complete Remission (CR)
Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected. Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected. Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.

Secondary Outcome Measures

Full Information

First Posted
August 6, 2015
Last Updated
April 5, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02519712
Brief Title
Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
Official Title
Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
July 28, 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test a method of bone marrow transplantation that results in only temporary donor immune function. In other words, the donor immune cells are given in a way that will allow them to attack leukemia briefly before being destroyed by their own immune system, or "rejected." The investigators want to test whether temporary donor immune function is enough to improve the odds of achieving a remission without exposing the patient to the toxicities of a full bone marrow transplant. To do this, the investigators will use standard chemotherapy for AML followed by an infusion of donor stem cells. The donor will be a family member who is haploidentically, or half matched, to the patient such as a child or sibling. Chemotherapy designed to treat AML should not be strong enough to prevent them from rejecting the donor stem cells. The investigators will then follow the patient to see how long the donor stem cells stay in them. The study will test whether this process is feasible and can result in improved chances of obtaining a remission.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia (AML)
Keywords
Induction Chemotherapy, G-CSF-Mobilized Stem Cells, Haploidentical Related Donors, 15-141

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells
Arm Type
Experimental
Arm Description
This is a single center trial to assess the feasibility of standard induction chemotherapy followed by a single dose of unmanipulated G-PBSC for the treatment of elderly patients with newly diagnosed AML.
Intervention Type
Drug
Intervention Name(s)
Induction Chemotherapy
Intervention Description
Patients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician.
Intervention Type
Procedure
Intervention Name(s)
G-PBSC Infusion
Intervention Description
G-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor.
Primary Outcome Measure Information:
Title
Complete Remission (CR)
Description
Peripheral Blood Counts: The peripheral blood neutrophil count should be ≥1,500/μl (sustained without growth factor support), and the platelets count should be ≥100,000/μl (without transfusion). No circulating blasts (in the absence of growth factor) should be detected. Bone Marrow Aspirate: The cellularity of the bone marrow should approximate normal. There must be evidence of maturation of all cell lines. The bone marrow aspirate should contain < 5% blasts. Auer rods should not be detected. Extramedullary Leukemia: Extramedullary leukemia, such as CNS or soft tissue involvement, must not be present.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 60. Patients with a new diagnosis of histologically confirmed (according to WHO classification 2008) acute myeloid leukemia (either primary or secondary AML) are included. Patients with a diagnosis of myelodysplastic syndrome with >/= 10% bone marrow blasts with no response or progression of disease after at least 4 cycles of a hypomethylating agent (5-azacytiine or decitabine). Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after G-CSF administration. Karnofsky performance status > 70%. Hepatic function - total bilirubin < 2 and, AST < 2.5 x upper limit of normal, unless liver is involved with disease or a history of Gilbert's disease. Renal function - adequate renal function as demonstrated by a serum creatinine <2 mg/dl. LVEF ≥ 50% as determined by echocardiogram or MUGA. Ability to give informed consent. Donor Eligibility: Donor is blood-related and HLA-haploidentical to the recipient. Donor ≥18 years old Donor has undergone serologic testing for transmissible diseases as per blood banking guidelines for organ and tissue donors. Tests include but are not limited to: HepBsAg, HepBsAb, HepBcAb, HepC antibody, HIV, HTLV I and II, VZV, CMV and VDRL, and West Nile Virus . Donor must have normal negative test results for HIV, HTLV I and II, and West Nile Virus. Donor has a CXR and EKG performed. Donor is not allergic to G-CSF. Donor must be able to undergo leukapheresis Donor is not pregnant. Donor does not have concurrent malignancy or autoimmune disease. Ability to give informed consent. Exclusion Criteria: Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 20080 Major surgery or irradiation within two weeks. Previous therapy with cytotoxic agents for AML. Persons with previous treatments for myelodysplasia/myeloproliferation such as hydroxyurea, interferon, hypomethylating agents (5-azacitidine or decitabine), lenalidomide, or JAK/STAT inhibitors may participate but must have >1 week off therapy prior to enrollment. Active CNS disease. Uncontrolled infection. Pregnant or lactating women - they are excluded, given the potential teratogenic effects of chemotherapy and agents used in the therapy. Male and female patients of child-bearing potential unwilling to use effective means of contraception. HIV or HTLV I/II seropositivity. Concurrent active malignancy other than AML requiring therapy. Clinically significant cardiac disease (NY Heart Association Class III or IV) or pulmonary disease. Inability or unwillingness to comply with the treatment protocol, follow-up, or research tests Donor Exclusion: Donor has cardiac risk factors precluding ability to undergo leukapheresis. Donor has evidence of concurrent malignancy or autoimmune disease. Donor is pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Shaffer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

Treatment of Elderly AML Patients With Induction Chemotherapy Followed by G-CSF-Mobilized Stem Cells From Haploidentical Related Donors

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