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

NCT02880293 | Completed Results

• 1 other identifier: 16-1237
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hematologic Malignancy

Keywords

transplant conditioning; KIR/HLA based haploidentical donor selection; allogeneic hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

• Proportion of Patients Undergoing an Allo HCT Transplant Who Have a KIR Favorable Donor.

  1 year

Study Arms (1)

Patients will undergo donor/recipient bone marrow

EXPERIMENTAL

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: melphalan; Drug: fludarabine; Drug: thiotepa; Drug: Cyclophosphamide; Drug: Mesna; Drug: Mycophenolate Mofetil; Drug: Filgrastim; Drug: Tacrolimus

Interventions

melphalan DRUG

melphalan (140 mg/m2 IV on day -7)

Also known as: Alkeran®

Patients will undergo donor/recipient bone marrow

fludarabine DRUG

fludarabine (40 mg/m2/d on days -5 through -2)

Also known as: FLUDARA®

Patients will undergo donor/recipient bone marrow

thiotepa DRUG

thiotepa (5 mg/kg IV on day -67)

Patients will undergo donor/recipient bone marrow

Cyclophosphamide DRUG

cyclophosphamide (50 mg/kg IV on day +3 and +4)

Also known as: Cytoxan®

Patients will undergo donor/recipient bone marrow

Mesna DRUG

Also known as: Mesnex®

Patients will undergo donor/recipient bone marrow

Mycophenolate Mofetil DRUG

(15 mg/kg PO/IV TID)

Also known as: CellCept®

Patients will undergo donor/recipient bone marrow

Filgrastim DRUG

Also known as: Neupogen®

Patients will undergo donor/recipient bone marrow

Tacrolimus DRUG

Also known as: Prograf®

Patients will undergo donor/recipient bone marrow

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Melphalan; fludarabine; fludarabine phosphate; Thiotepa; Cyclophosphamide; Mesna; Mycophenolic Acid; Filgrastim; Tacrolimus

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Macrolides; Lactones

Results Point of Contact

• Title: Dr. Brian Shaffer, MD
• Organization: Memorial Sloan Kettering Cancer Center

shaffeb1@mskcc.org

646-608-3737

Study Officials

• Brian Shaffer, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: August 26, 2016
• Study Start: August 23, 2016
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2023-11

Locations

US (1)