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Acute Myeloid LeukemiaPhase 3NCT02461121

HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

A Phase 3 study testing HLA mismatched stem cell, HLA matched stem cell and cyclosporine A in people with Acute Myeloid Leukemia, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.

Completed

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

Official record
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Trial summary

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis. Read more about this study

Who is it for?
Ages 9 to 59 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
HLA mismatched stem cell, HLA matched stem cell and cyclosporine A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
1 siteChina
Study dates
May 2004to May 2013
Phase
Phase 3
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 9 to 59 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients must have elderly (9-59 ages) AML pathologically confirmed per WHO guidelines.
  • Patients WITH intermediate-risk AML-CR1
  • Patients must have ECOG Performance status of 0,1,or 2. If ECOG 2.
  • Patients must have a HLA mismatched donor who should be able to provide informed consent.
  • All genders and races are eligible.
  • ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
  • By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
  • Donors must be able to safely undergo leukapheresis.

Who cannot join

  • received operation 4 weeks before randomization
  • acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
  • active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
  • Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
  • There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
  • Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
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  • Any situation processed by the PI that will be damaged to the patients safety.
  • Patients and / or authorized family member refuse to sign the consent. attend other clinical researchers in 3 months.
  • Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Affiliated Hospital of Academy of Military Medical Sciences ,

    Beijing, Beijing Municipality, 100071

Other trials in China

About this study

Official title: Compare the Safety and Effective of HLA-mismatched Microtransplantation With HLA-matched Nonmyeloablative Transplantation for Acute Myeloid Leukemia in Intermediate-risk

Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Read the detailed description

The optimal therapy for intermediate-risk patients with acute myeloid leukemia (AML) in first complete remission (CR1) is uncertain. Recent studies shown that microtransplantation (MST) can improve survival in AML-CR1 patients. However, a comparison study between the MST and nonmyeloablative stem cell transplantation (NST) is lacking. 156 intermediate-risk AML-CR1 patients aged 9 to 59 years were enrolled in this study. Patients with de novo AML enrolled in the study. Patient who has a HLA-identical donor is assigned to receive NST therapy with GVHD prophylaxis and who has no HLA-identical donor is assigned to receive MST therapy without GVHD prophylaxis.

Being tested
HLA mismatched stem cell, HLA matched stem cell, cyclosporine A, Mycophenolate mofetil, Ara-C
Keywords
Acute Myeloid Leukemia, microtransplantationHLA-mismatched microtransplantation, nonmyeloablative stem cell transplantation, graft-versus-host disease
Medical subject headings
Leukemia, Myeloid, Acute, Graft vs Host Disease

What participants receive

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

  • HLA mismatched stem cellGenetic

    Also called microtransplantation

    HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy

  • HLA matched stem cellGenetic

    Also called nonmyeloablative transplantation

    HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen

  • cyclosporine ADrug

    Also called GVHD prophylaxis

    The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil

  • Mycophenolate mofetilDrug

    Also called GVHD prophylaxis

    The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil

  • Ara-CDrug

    Also called conditioning reginmen

    2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose

  • fludarabineDrug

    Also called NST conditioning reginmen

    30 mg/m2/d for 5days

  • anti-lymphocyte globulinDrug

    Also called NST conditioning reginmen

    1.5-2 mg/kg/d for 4 days

  • cyclophosphamideDrug

    Also called NST conditioning reginmen

    40 mg/kg/d for 2 days

Study groups in NCT02461121
Study groupRoleWhat they receive
MST（microtransplantation）ExperimentalThe microtransplantation conditioning regimen included high-dose Ara-C chemotherapy (2.0 to 2.5 g/m2 per 12 hours intravenously on days -4 to -2) followed by an infusion of HLA mismatched stem cell 24 hours (day 0) after the completion of cytarabine.
Receives: Genetic: HLA mismatched stem cell; Drug: Ara-C
NST（nonmyeloablative transplantation）Active comparatorThe NST（nonmyeloablative transplantation）conditioning regimen consisted of 30 mg/m2/d fludarabine for days -6 to -2, 1.5-2 mg/kg/d anti-lymphocyte globulin for days -5 to -2, 40 mg/kg/d cyclophosphamide for days -4 and -2 and 2.0-3.0 g/m2/d cytarabine for days -6 to -4，followed by an infusion of HLA matched stem cell after the completion of regimen. The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
Receives: Genetic: HLA matched stem cell; Drug: cyclosporine A; Drug: Mycophenolate mofetil; Drug: Ara-C; Drug: fludarabine; Drug: anti-lymphocyte globulin; Drug: cyclophosphamide

What is being measured

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

  1. Overall Survival

    Measured: 10 years

Secondary outcomes (5)

  1. treatment-related mortality

    Measured: 2 years

  2. donor chimerism or microchimerism

    Measured: 10 years

  3. WT1+CD8+CTL

    donor versus leukemia effect

    Measured: 10 years

  4. GVHD

    Measured: 10 years

  5. disease free survival

    Measured: 10 years

Timeline

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

  1. First posted3 Jun 2015 (estimated)
  2. Study startMay 2004
  3. Primary completionMay 2013
  4. Study completionMay 2013

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02461121
Sponsor's protocol ID
MST vs NST
Status last verified
May 2015
First submitted
18 May 2015
Last updated
4 Jun 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing HLA mismatched stem cell, HLA matched stem cell and cyclosporine A in people with Acute Myeloid Leukemia, run by The Affiliated Hospital of the Chinese Academy of Military Medical Sciences at 1 site in China.

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 8 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 4 Jun 2015. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (time frame: 10 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 NCT02461121.

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 4 Jun 2015.

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