Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromePhase 1/2NCT02038153

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant

A Phase 1/2 study testing Laboratory Biomarker Analysis and Lenalidomide in people with Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome and Adult Acute Myeloid Leukemia in Remission, run by Albert Einstein College of Medicine at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 60 to 80 years
Conditions the study is for: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission
What is being tested?: Laboratory Biomarker Analysis and Lenalidomide
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 3 participants
Where: 3 sitesUnited States
Study dates: Dec 2013to Jan 2016
Phase: Phase 1/2
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 60 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable
Post autologous stem cell transplant bone marrow biopsy core that is consistent with morphologic remission
Must have received induction and consolidation chemotherapy, and autologous stem cell transplant for AML
Life expectancy of greater than 12 months
Karnofsky performance status 70 or greater
Leukocytes >= 2,000/mcL

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Absolute neutrophil count >= 1,000/mcL
Platelets >= 75,000/mcL
Total bilirubin =< 4 X institutional upper limit of normal unless 2nd to Gilbert's disease
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 4 X institutional upper limit of normal
Creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance >= 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
Able to take aspirin, or warfarin, or low molecular weight heparin as prophylactic anticoagulation
Ability to understand and the willingness to sign a written informed consent document
Must be registered into the mandatory RevAssist® program and be willing and able to comply with the requirement of RevAssist®

Who cannot join

Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient received another investigational agent after post autologous stem cell transplant
Patient who will be receiving another investigational product during the study
Patient who is growth factor or transfusion dependent
Patient has central nervous system leukemia
History of allergic reactions attributed to thalidomide or lenalidomide

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History of erythema nodosum, characterized by a desquamating rash while taking thalidomide or similar drugs
Prior history of metastatic malignancy
Uncontrolled illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements; patients must not have suffered recent (< 6 months) myocardial infarction, unstable angina, uncontrolled hypertension, or difficult to control cardiac arrhythmias
Evidence of uncontrolled congestive heart failure
Active hepatitis B as defined by hepatitis B surface antigen positivity, unless able to start dual anti-hepatitis B (HepB) therapy, or already on dual anti-HepB therapy
Patients who are positive for hepatitis B core antibody, but negative for the hepatitis B surface antigen, should be on lamivudine 100 mg daily until at least 3 months post-transplant
Patient is positive for human immunodeficiency virus (HIV) or human T-cell lymphotropic virus-1 (HTLV-1)
Women of childbearing potential (defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months)
Men who did not agree not to father a child and who refused to use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Albert Einstein College of Medicine
The Bronx, New York, 10461
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)

This phase I/II trial studies the side effects and best dose of lenalidomide and how well it works in treating older patients with acute myeloid leukemia (AML) who have undergone stem cell transplant. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the safety and efficacy of maintenance lenalidomide post autologous peripheral blood stem cell transplantation (PBSCT) for elderly patients with AML (AML).

SECONDARY OBJECTIVES:

To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of lenalidomide given post autologous transplant for AML.

II. To determine the progression free survival for patients treated with this approach.

III. To determine the overall survival for patients treated with this approach. IV. To determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after autologous PBSCT.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission
Being tested: Laboratory Biomarker Analysis, Lenalidomide

What participants receive

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

Laboratory Biomarker AnalysisOther
Correlative studies
LenalidomideDrug
Also called CC-5013, CC5013, CDC 501, Revlimid
Given PO

Study groups in NCT02038153
Study group	Role	What they receive
Treatment (lenalidomide)	Experimental	Patients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Lenalidomide

What is being measured

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

Relapse Free Survival Rate
The Relapse free survival rate is defined as the Leukemia free survival rate during the first two years after and during the initiation of treatment . The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be > 95%).
Measured: initial 2 years after treatment begins

Secondary outcomes (1)

Overall Survival
Kaplan-Meier analysis will be conducted.
Measured: From transplant until death of any cause, assessed up to 5 years

Timeline

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

Dec 2013Jan 2016

First posted16 Jan 2014 (estimated)
Study startDec 2013
Primary completionJan 2015
Study completionJan 2016

Why it stopped: Low accrual

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 Acute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 3 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02038153
Sponsor's protocol ID: 13-08-148
Other IDs: NCI-2013-02493, 13-08-148, P30CA013330
Status last verified: May 2020
First submitted: 15 Jan 2014
Last updated: 14 May 2020
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

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Not yet recruitingPhase 2
Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia

All Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II Study of Lenalidomide Maintenance After Autologous Stem Cell Transplant for Elderly Patients With Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT02038153
Acronym / sponsor ID: 13-08-148
Conditions: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Adult Acute Myeloid Leukemia in Remission
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low accrual
Enrolment: 3 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Dec 2013
Primary completion: Jan 2015 (actual)
Study completion: Jan 2016 (actual)
First posted: 16 Jan 2014 (estimated)
Results: Posted 14 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To determine the safety and efficacy of maintenance lenalidomide post autologous peripheral blood stem cell transplantation (PBSCT) for elderly patients with AML (AML).

SECONDARY OBJECTIVES:

To define maximum tolerated dose (MTD) and establish therapeutic dose level (TDL) of lenalidomide given post autologous transplant for AML.

II. To determine the progression free survival for patients treated with this approach.

III. To determine the overall survival for patients treated with this approach. IV. To determine the role of residual AML stem cells on efficacy of lenalidomide maintenance after autologous PBSCT.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6 months thereafter.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (lenalidomide)	Experimental	Other: Laboratory Biomarker Analysis, Drug: LenalidomidePatients receive lenalidomide PO QD on days 1-21. Courses repeat 4 weeks in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Patients must have a confirmed diagnosis of non-M3 AML; antecedent myelodysplastic syndrome (MDS) is acceptable
Post autologous stem cell transplant bone marrow biopsy core that is consistent with morphologic remission
Must have received induction and consolidation chemotherapy, and autologous stem cell transplant for AML
Life expectancy of greater than 12 months
Karnofsky performance status 70 or greater

Key exclusion criteria (15 listed)

Patient received chemotherapy or radiotherapy within 2 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier
Patient received another investigational agent after post autologous stem cell transplant
Patient who will be receiving another investigational product during the study
Patient who is growth factor or transfusion dependent
Patient has central nervous system leukemia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (lenalidomide)
LenalidomideAlso: CC-5013, CC5013, CDC 501, RevlimidGiven PO	Drug	Treatment (lenalidomide)

Primary outcome

Relapse Free Survival Rate
Time frame: initial 2 years after treatment begins
The Relapse free survival rate is defined as the Leukemia free survival rate during the first two years after and during the initiation of treatment . The observed relapse free survival rate will be calculated along with its 95% confidence interval. A one sample test on proportion will be used to detect if the relapse free survival rate with lenalidomide is significantly higher than that without the treatment (relapse rate is expected to be > 95%).

1 secondary outcome

Overall Survival
Time frame: From transplant until death of any cause, assessed up to 5 years

Results and safety

Results posted to the registry on 14 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Lenalidomide)	3	2

Primary outcome: Relapse Free Survival Rate

Time frame: initial 2 years after treatment begins

Population analysed: Study terminated because of low accrual. No analysis done

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Lenalidomide)	0 of 3 (0%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome

RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 2
MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Not yet recruitingPhase 2
Testing the Use of Combination Therapy in Patients With Persistent Low Level Acute Myeloid Leukemia Following Initial Treatment, The ERASE Study (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ira Braunschweig principal investigator

Albert Einstein College of Medicine

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 14 May 2020). 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?

Relapse Free Survival Rate (time frame: initial 2 years after treatment begins). 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 NCT02038153.

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 14 May 2020.