Haploidentical (Half-matched) Related Donor Stem Cell Transplantation Using Killer Immunoglobulin-like Receptors in Addition to Normal Selection Factors to Determine the Best Donor

November 11, 2024 updated by: Memorial Sloan Kettering Cancer Center

Partially HLA-Mismatched Related Donor Hematopoietic Stem Cell Transplantation Using Killer Immunoglobulin Receptor and Human Leukocyte Antigen Based Donor Selection

This study will test whether half matched donors with favorable KIR genes will reduce the risk of cancer recurring after transplant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients with any of the following hematologic malignancies who are considered to be eligible for allogeneic transplantation:

  • Acute lymphoid leukemia (ALL) in first complete remission (CR1) with high riskfor relapse including:
  • t(9;22) or detected BCR-ABL1 translocation by genomic methodologies
  • BCR-ABL1-Like B-ALL [54] including mutations of IKZF1 or CRLF2
  • Translocations or mutations involving 11q23 (MLL) gene.
  • Hypodiploid karyotype
  • Deletion of 9p
  • Loss of 17p or TP53 mutation
  • T-lymphocyte lineage antigen expression (T-ALL)
  • CNS or other extramedullary involvement
  • WBC count >/= 100,000 cells/μL at diagnosis
  • Relapsed ALL, biphenotypic/bilineal leukemia, or AML with </= 10% blasts in the bone marrow prior to transplantation
  • Acute biphenotypic or bilineal leukemia in first or greater complete remission.
  • Acute myeloid leukemia (AML) in CR1 with intermediate or high risk features including:
  • Cytogeneic abnormalities associated with myelodysplatic syndrome including abnormalities of chromosome 5 or 7
  • History of anti-neoplastic therapy (radiation or chemotherapy)
  • Extramedullary involvement
  • WBC count >/= 100,00 cells/ul at diagnosis
  • Rearrangements or mutations of 11q23 (MLL)
  • Abnormalities of chromosome 3
  • TP53 mutation or loss of 17p
  • Complex or monosomal karyotype
  • Normal karyotype with mutations of FLT3, RUNX1, or ASXL1
  • Myleodysplastic syndrome, myeloproliferative neoplasms, or MDS/MPN overlap syndrome with:
  • International prognostic scoring system risk score of INT-2 or high risk at the time of transplant evaluation
  • Any risk category if life-threatening cytopenia exists
  • Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype
  • Myelofibrosis with DIPSS scores of INT-2 or high risk or any risk category if life threatening cytopenias are present
  • Chronic myelomonocytic leukemia (CMML)
  • Chronic myeloid leukemia (CML) who have failed or are intolerant to BCR-ABL tyrosine kinase inhibitors
  • CML with BCR-ABL mutation consistent with poor response to tyrosine kinase inhibition (e.g. T351 l mutation)
  • CML with accelerated or blast phase with <20% blasts after therapy
  • Hodgkin lymphoma:
  • Relapsed disease with progression after autologous bone marrow transplant or are ineligible for this procedure
  • Responding to therapy prior to enrollment
  • Non-Hodgkin lymphoma:
  • Responding to therapy prior to enrollment
  • Progression after autologous bone marrow transplant or are ineligible for this procedure

  • Chronic lymphocytic leukemia with high risk disease as defined by the EBMT consensus criteria

    • Patients aged 18 through 69 years old are eligible
    • Patients aged 70-75 with HCT-CI of 0-1 are eligible
    • High risk hematologic malignancies
    • Patients must have Karnofsky performance status >/= 70%
    • Cardiac left ventricular ejection fraction >/= 50% at rest
    • Total bilirubin </= 2 mg/dL, except for patients with Gilbert's syndrome
    • AST and ALT </= 5x ULN unless thought to be disease related
    • Estimated or measured creatinine clearance > 50 mL/min
    • Hemoglobin adjusted pulmonary DLCO >/= 50% of predicted, if Hgb is within normal range, unadjusted DLCO must be >/= 50%

Exclusion Criteria:

  • Persons with a HLA matched sibling donor.
  • Female patients who are pregnant or breast-feeding
  • Persons with an infection that is not responding to antimicrobial therapy
  • Persons who are seropositive for HIV.
  • Persons with uncontrolled central nervous system malignancy •Persons who do not meet the age and organ function criteria specified above Presence of psychiatric or neurologic disease, or lack of social support that limits the patient's ability to comply with the treatment protocol including supportive care, follow-up, and research tests.

  • Prior diagnosis of non-hematologic malignancy within 5 years of planned protocol therapy EXCEPT:

    • Diagnosis of breast ductal carcinoma in situ treated with curative intent
    • Diagnosis of prostate adenocarcinoma with Gleasons score </= 6 treated with curative intent
    • Non-melanomatous skin cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients will undergo donor/recipient bone marrow
All patients will undergo haploidentical, allogeneic hematopoietic cell transplantation. Conditioning will consist of fludarabine, melphalan, and thiotepa. Graft versus host disease prophylaxis will be with post-transplant cyclophosphamide in addition to standard tacrolimus and mycophenolate mofetil. Donors will undergo HLA and KIR geno- and allotyping to determine the best donor.
Drug: Filgrastim
Other Names:
  • Neupogen®
Drug: Tacrolimus
Other Names:
  • Prograf®
Drug: Mesna
Other Names:
  • Mesnex®
Drug: melphalan
melphalan (140 mg/m2 IV on day -7)
Other Names:
  • Alkeran®
Drug: fludarabine
fludarabine (40 mg/m2/d on days -5 through -2)
Other Names:
  • FLUDARA®
Drug: thiotepa
thiotepa (5 mg/kg IV on day -67)
Drug: Cyclophosphamide
cyclophosphamide (50 mg/kg IV on day +3 and +4)
Other Names:
  • Cytoxan®
Drug: Mycophenolate Mofetil
(15 mg/kg PO/IV TID)
Other Names:
  • CellCept®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of Patients Undergoing an Allo HCT Transplant Who Have a KIR Favorable Donor.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Shaffer, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-1237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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