AzTrials
AzTrials

Hematologic MalignancyNCT02880293

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

A study testing melphalan, fludarabine and thiotepa in people with Hematologic Malignancy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Hematologic Malignancy
What is being tested?
melphalan, fludarabine and thiotepa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteUnited States
Study dates
23 Aug 2016to 20 Nov 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 48Show fewer
  • 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%

Who cannot join

  • 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:
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: 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.

Being tested
melphalan, fludarabine, thiotepa, Cyclophosphamide, Mesna
Keywords
transplant conditioning, KIR/HLA based haploidentical donor selection, allogeneic hematopoietic cell transplantation
Medical subject headings
Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • melphalanDrug

    Also called Alkeran®

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

  • fludarabineDrug

    Also called FLUDARA®

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

  • thiotepaDrug

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

  • CyclophosphamideDrug

    Also called Cytoxan®

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

  • MesnaDrug

    Also called Mesnex®

  • Mycophenolate MofetilDrug

    Also called CellCept®

    (15 mg/kg PO/IV TID)

  • FilgrastimDrug

    Also called Neupogen®

  • TacrolimusDrug

    Also called Prograf®

Study groups in NCT02880293
Study groupRoleWhat they receive
Patients will undergo donor/recipient bone marrowExperimentalAll 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.
Receives: Drug: melphalan; Drug: fludarabine; Drug: thiotepa; Drug: Cyclophosphamide; Drug: Mesna; Drug: Mycophenolate Mofetil; Drug: Filgrastim; Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2016 (estimated)
  2. Study start23 Aug 2016
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02880293
Sponsor's protocol ID
16-1237
Status last verified
Nov 2023
First submitted
23 Aug 2016
Last updated
6 Dec 2024

Questions about this trial

What is this clinical trial studying?

A study testing melphalan, fludarabine and thiotepa in people with Hematologic Malignancy, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 48 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients Undergoing an Allo HCT Transplant Who Have a KIR Favorable Donor. (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02880293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in