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LeukemiaPhase 2NCT00274846

Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

A Phase 2 study testing aldesleukin, therapeutic allogeneic lymphocytes and cyclophosphamide in people with Leukemia, run by Masonic Cancer Center, University of Minnesota 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
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Trial summary

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Leukemia
What is being tested?
aldesleukin, therapeutic allogeneic lymphocytes and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
Mar 2005to Jun 2008
Phase
Phase 2
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 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
  • Primary refractory disease (no complete response [CR] after ≥ 2 induction therapies)
  • Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy
  • Secondary AML from myelodysplastic syndromes
  • Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants)
  • Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib
Show all 13Show fewer
  • Over 60 years of age with relapse within 6 months after completion of last chemotherapy
  • Over 60 years of age with blast count < 30% within 10 days before study entry
  • Related HLA-haploidentical natural killer cell donor available
  • No severe organ damage (by clinical or laboratory assessment)
  • Performance status 50-100%
  • No evidence of active infection on chest X-ray
  • No active fungal infection

Who cannot join

  • Active central nervous system (CNS) leukemia
  • Pleural effusions large enough to be detectable by chest x-ray
  • Pregnant or nursing (positive pregnancy test)
  • Fertile patients must use effective contraception
  • Less than 60 days since prior transplant
  • Less than 3 days since prior prednisone
  • Less than 3 days since other prior immunosuppressive medication

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: Allogeneic Natural Killer Cells in Patients With Relapsed Acute Myelogenous Leukemia

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.

PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.

Read the detailed description

OBJECTIVES:

Primary

  • Evaluate the in vivo expansion of natural killer (NK) cells 14 days after treatment with allogeneic NK cell-enriched peripheral blood stem cell transplantation in patients with relapsed acute myeloid leukemia.

Secondary

  • Determine the response rate, in terms of complete remission, in patients treated with this regimen.
  • Correlate complete remission rate with NK cell expansion, interleukin-15 levels, and donor/recipient killer immunoglobulin receptor (KIR) ligand matching status in patients treated with this regimen.
  • Determine the overall and progression-free survival of patients treated with this regimen.
  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is an open-label study.

  • Induction therapy: Patients receive fludarabine IV on days -6 to -2 and cyclophosphamide IV on day -5 or on days -5 and -4.
  • Allogeneic natural killer (NK) cell-enriched peripheral blood stem cell transplantation: Patients receive allogeneic NK cell-enriched peripheral blood stem cells IV over 15-60 minutes on day 0. Patients also receive interleukin-2 subcutaneously beginning on day 0 and continuing 3 times a week for up to 2 weeks.

After completion of study treatment, patients are followed periodically for 3 months.

Conditions
Leukemia
Being tested
aldesleukin, therapeutic allogeneic lymphocytes, cyclophosphamide, fludarabine phosphate, in vitro treated peripheral blood stem cell transplantation
Keywords
recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, secondary acute myeloid leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
Medical subject headings
Leukemia, Leukemia, Myeloid, Acute, Congenital Abnormalities

What participants receive

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

  • aldesleukinBiological

    Also called IL-2

    10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses

  • therapeutic allogeneic lymphocytesBiological

    Also called lymphocytes

    Cells infused per kg. 1.5-8.0 x 10^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10^9

  • cyclophosphamideDrug

    Also called Cytoxan

    Days -5 and -4: 60 mg/kg

  • fludarabine phosphateDrug

    Also called Fludara

    Days -5 through -2: 25 mg/m^2

  • in vitro treated peripheral blood stem cell transplantationProcedure or surgery

    Also called Natural Killer Cells

    Day 0 infuse natural killer cells

Study groups in NCT00274846
Study groupRoleWhat they receive
Intent-to-TreatExperimentalAll patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10^7/kg.)
Receives: Biological: aldesleukin; Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Procedure: in vitro treated peripheral blood stem cell transplantation

What is being measured

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

  1. Number of Patients With Natural Killer (NK) Cell Expansion

    Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (>100 donor-derived NK cells per uL of patient blood detectable at day +14).

    Measured: Study Day 14

Secondary outcomes (4)

  1. Number of Patients With Complete Remission

    Clinical response is determined by achievement of a complete remission (CR) as judged by morphological criteria (< 1% blasts in bone marrow with neutrophil recovery).

    Measured: Day 28-35

  2. Median Time to Disease Relapse (Months)

    Follow-up continued every 3 months after the allogeneic natural killer (NK) cell infusion, unless they were transplanted, relapsed or had progressive disease. Time in months to relapse of disease is calculcated from 1st day of treatment with NK cells. Relapse occurs when leukemia is detected in bone marrow or blood.

    Measured: From 1st Day of treatment until death or receipt of bone marrow transplant.

  3. Overall Survival Time of Patients With Complete Remission

    Median number of months patients were alive after NK cell infusion.

    Measured: From Day 1 of Treatment until death or patient received bone marrow transplant.

  4. Number of Patients With Complete Remission and Natural Killer Cell Expansion

    Includes patients who had both a complete remission of disease and an expansion of natural killer cells.

    Measured: Day 14

Timeline

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

  1. First posted11 Jan 2006 (estimated)
  2. Study startMar 2005
  3. Primary completionJun 2008
  4. Study completionJun 2008

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274846
Sponsor's protocol ID
CDR0000450852
Other IDs
UMN-2004LS073, UMN-MT2004-25
Status last verified
Dec 2017
First submitted
10 Jan 2006
Last updated
28 Dec 2017
Data monitoring committee
Yes

Publications

  • Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9.

    PubMed 24719405

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing aldesleukin, therapeutic allogeneic lymphocytes and cyclophosphamide in people with 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 13 inclusion and 7 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 28 Dec 2017. 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?

Yes. Results are posted in the registry (first posted 7 Sep 2009). 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?

Number of Patients With Natural Killer (NK) Cell Expansion (time frame: Study Day 14). 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 NCT00274846, which also lists 1 linked publication.

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 28 Dec 2017.

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