Azacitidine + Lenalidomide Combo in the Elderly With Previously Treated AML & High-Risk MDS

NCT01442714 | Terminated Phase 2 Results DMC

• 4 other identifiers: IRB-21686SU-08122011-8268HEM0022VIREL2
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the trial is to study how the elderly patients who have previously undergone treatment for acute myeloid leukemia and high-rRisk myelodysplastic syndromes, respond to a combined treatment with azacitidine and lenalidomide.

Conditions

Leukemia; Acute Myeloid Leukemia (AML); Myelodysplastic Syndromes (MDS)

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Overall response rate was defined as the sum of Complete Response (CR) + CR with incomplete count recovery (CRi) + Partial Response (PR).

  203 days

Secondary Outcomes (2)

• Median Duration of Response

  203 days

• Overall Survival

  462 Days

Study Arms (1)

Azacitidine plus Lenalidomide

EXPERIMENTAL

Patients will receive a single dose of azacitidine 75 mg/m² SC or IV on days 1 to 7, followed by lenalidomide 50 mg PO daily on days 8 to 28 of a 42-day cycle.

Drug: Azacitidine; Drug: Lenalidomide

Interventions

Azacitidine DRUG

Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death

Also known as: 5-azacytidine, Vidaza

Azacitidine plus Lenalidomide

Lenalidomide DRUG

Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory activity.

Also known as: CC-5013, Celgene, Revlimid

Azacitidine plus Lenalidomide

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute myeloid leukemia (AML) (according to the WHO 2008 classification):
• De novo
• Secondary AML previously treated with demethylating agents for AML
• Secondary AML previously treated with demethylating agents for MDS
• Secondary AML previously treated with high dose lenalidomide for AML (≥ 25mg)
• High Risk MDS:
• Del (5q)
• Non-del (5q), previously-treated with lenalidomide.
• Novo or secondary HR-MDS previously treated with demethylating agents
• White blood cell (WBC) ≤ 10,000
• Age ≥ 60
• Not an immediate candidate for allogeneic stem cell transplantation
• Unwilling or unable to receive conventional chemotherapy
• Prior therapy:
• with single agent demethylator (5-Azacitidine or Decitabine)

You may not qualify if:

• Patients with LR-MDS progressing to HR-MDS after low dose lenalidomide or 5-day azacitidine will not be eligible.
• History of intolerance to thalidomide
• development of erythema nodosum while taking thalidomide or similar drugs
• Known or suspected hypersensitivity to azacitidine or mannitol
• Patients with advanced malignant hepatic tumors.
• Concomitant treatment with other anti-neoplastic agents, with the exception of hydroxyurea
• Previous participation on the VIREL study with the concomitant use of azacitidine plus lenalidomide.
• Anti-neoplastic treatment less than four weeks prior to enrollment, with the exception of hydroxyurea
• Use of any other experimental drug or therapy within 28 days of baseline
• Inability to swallow or absorb drug
• Active opportunistic infection or treatment for opportunistic infection within four weeks of first day of study drug dosing
• New York Heart Association Class III or IV heart failure
• Unstable angina pectoris
• Uncontrolled cardiac arrhythmia
• Uncontrolled psychiatric illness that would limit compliance with requirements

Sponsors & Collaborators

• Stanford University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Azacitidine; Lenalidomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Bruno Medeiros
• Organization: Stanford University

brunom@stanford.edu

650-723-5007

Study Officials

• Bruno Carneiro de Medeiros

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Medicine Hematology

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 28, 2011
• Study Start: August 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 3, 2018
• Results First Posted: January 3, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)