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Adult Acute Myeloid Leukemia in RemissionPhase 2NCT02587871

Donor Cellular Therapy After Cytarabine in Treating Patients With Intermediate-Risk Acute Myeloid Leukemia in Remission

A Phase 2 study testing Cytarabine, Laboratory Biomarker Analysis and Peripheral Blood Stem Cell Transplantation in people with Adult Acute Myeloid Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by University of Southern California at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase II trial studies how well donor cellular therapy after cytarabine works in treating patients with intermediate-risk acute myeloid leukemia with a decrease in or disappearance of signs and symptoms of cancer. Read more about this study

Who is it for?
Ages Up to 59 years
What is being tested?
Cytarabine, Laboratory Biomarker Analysis and Peripheral Blood Stem Cell Transplantation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
12 Dec 2018to 12 Nov 2022
Phase
Phase 2
Are there results?
None posted in the registry

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 Up to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • PATIENT INCLUSION CRITERIA:
  • Acute myeloid leukemia-intermediate risk as defined by standard World Health Organization (WHO) criteria for AML (at least 20% blasts in the peripheral blood or bone marrow) at the time of initial diagnosis
  • Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with French-American-British (FAB) classification other than M3 (acute promyelocytic leukemia), documented by bone marrow aspiration and biopsy performed within 14 days prior to administration of 1st dose of remission induction chemotherapy
  • Intermediate risk based on National Comprehensive Cancer Network (NCCN)
  • In CR or complete remission with incomplete blood count recovery (CRi) after 1-2 induction chemotherapy documented by a bone marrow examination done within 2 weeks of starting cytarabine in this protocol
  • Must have achieved CR/CRi with less than 2 induction regimens that contain cytarabine and anthracycline
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  • No 10/10 matched sibling donor available or not financially eligible for allogeneic stem cell transplantation
  • Must be within 3 months from the last induction regimen at the time of starting cytarabine chemotherapy in this protocol
  • Patient has at least one medically fit first- or second-degree family member expected to be human leukocyte antigen (HLA) mismatched at 2-9/10 loci; in addition, the prospective donor is willing to voluntarily donate hematopoietic stem cells and sign consent forms
  • Absolute neutrophil count (ANC) > 1500, unless due to direct bone marrow involvement of disease
  • Platelets > 75,000, unless due to direct bone marrow involvement of disease
  • Hemoglobin > 8.0 gm/dL, transfusion allowed
  • Serum creatinine < 2.0 x the upper limits of institutional normal (ULN)
  • Total bilirubin < 1.5 x the upper limits of institutional normal
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 2.5 x the upper limits of institutional normal (=< 5 x ULN for patients with suspected liver involvement of leukemia)
  • Cardiac left ventricular ejection fraction (LVEF) > 45%
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2, and estimated survival of at least 3 months
  • Patients must be able to understand and agree to sign an Institutional Review Board (IRB)-approved informed consent form
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry, for the duration of study, and for two months after study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • DONOR INCLUSION CRITERIA:
  • Donor screening; all donors will meet the standard blood donor criteria established by the participating local blood center, American Association of Blood Banks (AABB)
  • Donors will be selected from among the subject's relatives, adult children preferred
  • Infectious disease testing will be done per Hemacare policy and AAAB guidelines
  • Donor and intended recipient red cell type and compatibility will be determined
  • Donors will be pre-selected on the basis of HLA haploidentity
  • If patient is cytomegalovirus (CMV)-negative, donors who are CMV-negative will be preferred; CMV serology of the donor will be tested prior to the allogeneic cell donation; donations from CMV-positive donors to CMV-negative recipients will be given if no CMV negative donor is available, and CMV surveillance and pre-emptive treatment given as per guidelines below

Who cannot join

  • PATIENT EXCLUSION CRITERIA:
  • Acute promyelocytic leukemia
  • High risk AML (see NCCN risk criteria)
  • Low risk AML (see NCCN risk criteria)
  • Fludarabine based therapy within 6 months of enrollment
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
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  • Who are pregnant and/or lactating
  • Who have had non-biopsy surgery in the last 10 days
  • Who have active central nervous system (CNS) disease; patients with previously treated leptomeningeal disease without evidence of remaining leukemia cells by spinal fluid will be eligible
  • Patients with known active autoimmune disorder
  • Patients known to be have active hepatitis B or C; (hepatitis B positive patients are allowed if they are on appropriate antiviral agents such as lamivudine)
  • Patients concurrently taking the following drugs are excluded: mycophenolate, cyclosporine, prednisone > 20 mg/day, or immunosuppressive agents
  • Researchers think that any life-threatening illness, condition or organ system dysfunction can damage the safety of subjects
  • Failure to demonstrate adequate compliance with medical therapy and follow-up
  • DONOR EXCLUSION CRITERIA:
  • Personal or family history of severe sickle cell disease or variant (unless donor has tested negative); testing for the presence of hemoglobin S is not required
  • Positive infectious disease test as dictated by blood collection center's standard operating procedure (SOP)
  • Current uncontrolled hypertension
  • Pregnant or breast-feeding
  • Currently taking lithium therapy
  • History of autoimmune disease

Trial locations and contacts

1 site in 1 country.

United States1 site

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: HLA-Mismatched Allogeneic Cellular Therapy (Microtransplantation) After Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia &lt; 60 Years

This phase II trial studies how well donor cellular therapy after cytarabine works in treating patients with intermediate-risk acute myeloid leukemia with a decrease in or disappearance of signs and symptoms of cancer. Donor cellular therapy is a short-term transfusion of cells from a family member who is incompletely matched. The use of these partially matched white blood cells may help improve response to standard chemotherapy (cytarabine) and reduce some of the risks of infection, without a permanent transplant. Drugs used in chemotherapy, such as cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving donor cellular therapy after cytarabine may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess 2-year disease-free survival (as defined by time to death from any cause or disease relapse, whichever is earlier) for patients < 60 years of age with intermediate-risk acute myeloid leukemia (AML), in complete remission (CR) after induction chemotherapy, who receive microtransplantation, compared to patients who received consolidation chemotherapy only in a historical published comparable cohort of patients.

SECONDARY OBJECTIVES:

  1. To obtain estimates of rate of relapse, treatment related mortality (TRM), all cause mortality, in the microtransplantation (MST) group and compare it with allogeneic stem cell group (historical cohort).

II. To obtain estimates of rate acute graft-versus-host disease (GVHD), chronic GVHD, time to recovery of absolute neutrophil counts and platelets in patients with intermediate risk AML receiving of chemotherapy in combination with microtransplantation.

TERTIARY OBJECTIVES:

  1. Presence or absence of detectable donor chimerism post-microtransplantation until 6 months after the last infusion.

II. Characteristics of the infused cells and composition of the graft. III. Dynamics of T-cell clonality. IV. Immune cell subset analysis.

OUTLINE:

Approximately 4-6 weeks after completion of induction chemotherapy, patients receive cytarabine intravenously (IV) over 1-3 hours twice daily (BID) on days -7 to -2 and granulocyte colony stimulating factor (G-CSF) mobilized peripheral blood cells (microtransplant) IV over 15-20 minutes on day 0. Treatment repeats every 8-10 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at least every 3 months for 2 years.

Being tested
Cytarabine, Laboratory Biomarker Analysis, Peripheral Blood Stem Cell Transplantation, Therapeutic Allogeneic Lymphocytes, G-CSF mobilized peripheral blood cells

What participants receive

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

  • CytarabineDrug

    Also called .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Also called PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

    Undergo microtransplant

  • Therapeutic Allogeneic LymphocytesBiological

    Also called Allogeneic Lymphocytes, Tumor-Derived Lymphocyte

    Undergo microtransplant

  • G-CSF mobilized peripheral blood cellsBiological

    Also called Filgrastim

    microtransplantation

Study groups in NCT02587871
Study groupRoleWhat they receive
Treatment (cytarabine, G-CSF mobilized peripheral blood cells)ExperimentalApproximately 4-6 weeks after completion of induction chemotherapy, patients receive cytarabine IV over 1-3 hours BID on days -7 to -2 and G-CSF mobilized peripheral blood cells (microtransplant) IV over 15-20 minutes on day 0. Treatment repeats every 8-10 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Cytarabine; Other: Laboratory Biomarker Analysis; Procedure: Peripheral Blood Stem Cell Transplantation; Biological: Therapeutic Allogeneic Lymphocytes; Biological: G-CSF mobilized peripheral blood cells

What is being measured

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

  1. Disease free survival (DFS)

    The 2-year DFS will be estimated, and the corresponding 90% confidence intervals will be constructed. The data will be displayed using a Kaplan-Meir curve to plot the DFS over time. Calculate bilateral 95% confidential interval of mean difference of disease-free survival rate, and compare the lower limit of the bilateral 95% confidential interval and 15% superiority boundary value.

    Measured: Beginning of therapy to the date of death or the date of last follow-upexamination, assessed at 2 years

Secondary outcomes (1)

  1. Cumulative incidence acute GVHD, classified as clinically significant (grades 2 to 4) or severe (grades 3 to 4)

    At single time point, if univariate quantitative data of the meets the normal distribution and homogeneity of variance, perform test of univariate quantitative data, otherwise, adopt the rank-sum test of corresponding design; for univariate quantitative data under multiple time points, use mixed effects model to design variance analysis with repeated measure factors.

    Measured: 6 months after microtransplant

Timeline

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

  1. First posted27 Oct 2015 (estimated)
  2. Study start12 Dec 2018 (estimated)
  3. Primary completion12 Nov 2020 (estimated)
  4. Study completion12 Nov 2022 (estimated)

Why it stopped: PI decided not to pursue study

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587871
Sponsor's protocol ID
9L-15-2
Other IDs
NCI-2015-01671, 9L-15-2, P30CA014089
Status last verified
Nov 2018
First submitted
23 Oct 2015
Last updated
9 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cytarabine, Laboratory Biomarker Analysis and Peripheral Blood Stem Cell Transplantation in people with Adult Acute Myeloid Leukemia in Remission and Childhood Acute Myeloid Leukemia in Remission, run by University of Southern California 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 26 inclusion and 21 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: withdrawn, as of the sponsor's last update on 9 Nov 2018. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Disease free survival (DFS) (time frame: Beginning of therapy to the date of death or the date of last follow-upexamination, assessed at 2 years). 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 NCT02587871.

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 9 Nov 2018.

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