Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesPhase 2NCT01083706

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

A Phase 2 study testing azacitidine and laboratory biomarker analysis in people with Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), run by Fred Hutchinson 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

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Trial summary

Who is it for?: Any age
Conditions the study is for: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
What is being tested?: azacitidine and laboratory biomarker analysis
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: Apr 2010to Dec 2013
Phase: Phase 2

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

MDS, CMML or AML patients (as diagnosed by World Health Organization [WHO] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
Recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (FISH) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
Morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
Flow Cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
Extramedullary relapse (local radiotherapy will be allowed)
MDS, CMML, or AML patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study

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Persistence of cytogenetic abnormalities by standard karyotype or FISH
Persistent morphologic evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
Persistent flow cytometric evidence of abnormal myeloblasts (in patients with CMML the monoblastoid population is included) in peripheral blood or marrow
Extramedullary persistence or regression

Who cannot join

Refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by International Working Group (IWG) criteria
>= 10% bone marrow myeloblasts as measured by morphology
Evidence of central nervous system (CNS) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [LP] is not required at time of relapse)
Serum creatinine > 2 x ULN (upper limit of normal)
Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2x ULN
Performance status > 2 (Eastern Cooperative Oncology Group [ECOG] Scale)
Patients with severe disease other than MDS, CMML or AML which would be expected to prevent compliance with treatment
Patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Treatment of Post-Transplant Relapse and Persistent Disease in Patients With MDS, CMML and AML With Azacitidine

This phase II trial studies how well azacitidine works in treating patients with relapsed myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Read the detailed description

PRIMARY OBJECTIVES:

To improve overall survival in patients with post-transplant relapse of myeloid malignancies.

OUTLINE:

Patients receive azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), 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)
Being tested: azacitidine, laboratory biomarker analysis
Medical subject headings: Congenital Abnormalities, Leukemia, Myelomonocytic, Chronic, Leukemia, Myeloid, Acute

What participants receive

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

azacitidineDrug
Also called 5-AC, 5-azacytidine, azacytidine, Vidaza
Given SC or IV
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01083706
Study group	Role	What they receive
Treatment (chemotherapy)	Experimental	Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: azacitidine; Other: laboratory biomarker analysis

What is being measured

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

Overall Survival
Count of surviving participants at 6 months.
Measured: 6 months

Secondary outcomes (2)

Rate of Response by IWG Criteria
Count of participants achieving a complete or partial remission at 6 months.
Measured: 6 months
Incidence of Grades II-IV Graft-versus-host Disease (GVHD)
Measured: 6 months

Timeline

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

Apr 2010Dec 2013

First posted10 Mar 2010 (estimated)
Study startApr 2010
Primary completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01083706
Sponsor's protocol ID: 2240.00
Other IDs: NCI-2010-00281, 2240.00, P30CA015704, P01CA078902
Status last verified: Apr 2017
First submitted: 8 Mar 2010
Last updated: 24 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)

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