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High-Risk Acute Myeloid LeukemiaPhase 2NCT03365661

QUILT-3.034: Non-Myeloablative TCRa/b Deplete Haplo HSCT With Post ALT-803 for AML

A Phase 2 study testing ALT-803 in people with High-Risk Acute Myeloid Leukemia and Treatment-Related Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
ALT-803
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
30 Oct 2018to 1 Jan 2023
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 to ≤70 years
  • Meets one of the following disease and risk categories:
  • High-Risk Acute Myeloid Leukemia (AML) with predicted risk of relapse higher than 30%, which includes, but not limited to the following:
  • Patients in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers.
  • Patients with the following karyotypes in morphological CR or CRi: ELN-Intermediate I, Adverse, ELN-Intermediate-II. (18) (Examples include monosomal karyotype, complex karyotype, mutant p53, mutant RUNX1, mutant ASXL1, mutant FLT3-ITD, mutant DNMT3A, Inversion 3, T(6:9), KIT mutated core binding factor AML)
  • Treatment-Related AML and Secondary AML in morphological remission (CR1 or beyond) with minimal residual disease as quantified either by flow cytometry, or by cytogenetics or molecular markers
Show all 19Show fewer
  • Myelodysplastic Syndrome (MDS) with < 5% blasts by morphology and meets at least one of the following:
  • Received intensive induction chemotherapy (i.e. 7+3 or MEC) OR
  • Progression after 4 cycles of hypomethylating agents
  • The donor and recipient must be HLA identical for at least one haplotype (using high resolution DNA based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1
  • Karnofsky performance status ≥ 60% (appendix IV)
  • Adequate organ function within 14 days of study registration (30 days for pulmonary and cardiac) defined as:
  • Hepatic: AST and ALT < 3 x upper limit of institutional normal
  • Renal: estimated glomerular filtration rate (GFR) ≥ 40 mL/min/1.73m2
  • Pulmonary: oxygen saturation ≥ 90% on room air with no symptomatic pulmonary disease. If symptomatic or prior known impairment DLCOcor ≥ 40%.
  • Cardiac: LVEF ≥ 40% by echocardiography, MUGA, or cardiac MRI, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
  • Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to transplant (excluding preparative regimen pre-medications)
  • Sexually active females of child bearing potential and males with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy
  • Voluntary written consent prior to the performance of any research related procedures

Who cannot join

  • Acute leukemias of ambiguous lineage
  • Allogeneic transplant for AML within the previous 6 months (no time limit for autologous transplant)
  • Active CNS disease - if a history of AML related CNS involvement, screening CSF analysis must be negative
  • Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test at screening
  • Active autoimmune disease requiring systemic immunosuppressive therapy
  • History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
Show all 11Show fewer
  • New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan unless cleared for study by Pulmonary. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections).
  • Uncontrolled bacterial, fungal or viral infections including HIV-1/2 or active hepatitis C/B - chronic asymptomatic viral hepatitis is allowed
  • Active concomitant second malignancy (i.e. has required treatment in the previous 6 months)
  • Known hypersensitivity to any of the study agents
  • Received any investigational drugs within the 14 days before 1st dose of fludarabine

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Masonic Cancer Center

    Minneapolis, Minnesota, 55455

Other trials in United States

About this study

Official title: QUILT-3.034: Multi-Center Trial of Non-Myeloablative TCRa/b Deplete Haploidentical Hematopoietic Cell Transplantation With Post HCT ALT-803 in High-Risk Myeloid Diseases

This is a phase II multi-institutional therapeutic study of a non-myeloablative T cell receptor (TCR) alpha/beta depleted haploidentical transplantation with post-transplant immune reconstitution using ALT-803 for the treatment of high-risk myeloid leukemia (AML), treatment-related/secondary AML, and myelodysplastic syndrome (MDS).

Being tested
ALT-803
Keywords
AML, MDS
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

  • ALT-803Biological

    A reduced intensity conditioning starts on Day -6, (CY/FLU/TBI/TLI) followed by infusion of a TCRα/β-deplete haploidentical graft on Day 0. Two doses of ALT-803 are given initially (early) 1 week apart to facilitate NK cell expansion. ALT-803 maintenance (late) for immune reconstitution begins at Day 42 and consists of 4 weekly doses, followed by 4 weeks off. Up to four 8 week treatment courses are permitted. No post-transplant GVHD prophylaxis is administered unless the final donor cell product contains > 2 x 105 α/β T cells/kg recipient weight.

Study groups in NCT03365661
Study groupRoleWhat they receive
ALT-803ExperimentalNot described
Receives: Biological: ALT-803

What is being measured

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

  1. Incidence of disease response

    Rate of donor neutrophil engraftment in the absence of disease at Day +28. Neutrophil engraftment is defined as absolute neutrophil count (ANC) ≥ 5 X 10 8 /L.

    Measured: Day 28

Secondary outcomes (7)

  1. Disease Free Survival (DFS)

    Incidence of disease free survival (DFS).

    Measured: 12 months

  2. Treatment Related Mortality (TRM)

    Incidence of treatment related mortality (TRM).

    Measured: 12 months

  3. Disease Relapse

    Incidence of disease relapse.

    Measured: 12 months

  4. Grade II-IV acute Graft versus Host Disease (aGVHD)

    Incidence of acute Graft versus Host Disease measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.

    Measured: Day 100

  5. Serious Adverse Events from ALT-803 (Early Schedule)

    Incidence of serious adverse events from ALT-803 will be measured for an initial 2 doses, given one week apart.

    Measured: 1 Year

  6. Serious Adverse Events from ALT-803 (Late Schedule)

    Incidence of serious adverse events from ALT-803 will be measured for 16 doses, given over 4 weeks.

    Measured: 1 Year

  7. Chronic Graft versus Host Disease (cGVHD)

    Incidence of chronic Graft versus Host Disease will be measured by the number of T-cells infused or NK cells engrafted causing GVHD syndrome.

    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 posted7 Dec 2017
  2. Study start30 Oct 2018 (estimated)
  3. Primary completion1 Jan 2023 (estimated)
  4. Study completion1 Jan 2023 (estimated)

Why it stopped: Sponsor halted 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
NCT03365661
Sponsor's protocol ID
2016LS057
Other IDs
MT2016-06
Status last verified
Nov 2018
First submitted
3 Dec 2017
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 ALT-803 in people with High-Risk Acute Myeloid Leukemia and Treatment-Related Acute Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota 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 19 inclusion and 11 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?

Incidence of disease response (time frame: Day 28). 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 NCT03365661.

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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