NCT01556477

Brief Summary

The proposed phase II trial is a multicenter, randomized, open-label study that will evaluate the efficacy and safety of azacitidine alone or in combination with lenalidomide in high-risk Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) with a karyotype including del(5q). The primary objective will be to evaluate the efficacy in terms of response according to International Working Group (IWG) criteria for MDS and AML after 6 cycles of azacitidine or azacitidine + lenalidomide treatment, or at end of study if this occurs at an earlier time point.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

2.3 years

First QC Date

March 12, 2012

Last Update Submit

March 14, 2012

Conditions

Myelodysplastic SyndromeAcute Myelogenous Leukemia

Keywords

MDSAMLAzacitidineLenalidomidedel5q

Outcome Measures

Primary Outcomes (1)

  • Response according to IWG criteria for MDS and AML

    Response according to IWG criteria include hematologic response (including transfusion independence), bone marrow response (blast count) and cytogenetic response (karyotype) after 6 cycles of azacytidine or azacytidine+lenalidomide. For patients who can keep the 4 week interval the Time Frame will be 25 weeks. The cycle interval can be extended up to 8 weeks which makes 44 weeks the maximum Time Frame.

    25-44 weeks (after 6 cycles of azacitidine or azacitidine+lenalidomide)

Secondary Outcomes (6)

  • Cytogenetic response after 3 cycles using Fluorescence In Situ Hybridization(FISH)

    25-44 weeks

  • Safety (number and types of adverse advents) in azacitidine vs azacitidine + lenalidomide groups

    25-44 weeks

  • Azacitidine cycle interval between groups

    25-44 weeks

  • Survival in azacitidine vs azacitidine + lenalidomide groups

    Up to week 156

  • Relapse in azacitidine vs azacitidine + lenalidomide groups

    Up to week 156

  • +1 more secondary outcomes

Study Arms (2)

azacitidine

ACTIVE COMPARATOR
Drug: Azacitidine

azacitidine + lenalidomide

EXPERIMENTAL
Drug: azacitidine + lenalidomide

Interventions

AzacitidineDRUG

Azacitidine 5-2-2 (75 mg/m2/day subcutaneously for 5 days, followed by a 2-day weekend break, followed by azacitidine 75 mg/m2/ day for 2 days every 28 days, no individual dose exceeding 200 mg) for 6 cycles.

Also known as: Vidaza
azacitidine
azacitidine + lenalidomideDRUG

Azacitidine 5-2-2 (75 mg/m2/day subcutaneously for 5 days, followed by a 2-day weekend break, followed by azacitidine 75 mg/m2/ day for 2 days every 28 days, no individual dose exceeding 200 mg) for 6 cycles. Initial dose of lenalidomide is 10 mg 21/28 days, starting day 1 in each azacitidine cycle and leaving the last week before start of next azacitidine cycle free. The dose should increased to 25 mg day 1 in cycle 4 if no toxicity according to predefined criteria occurs. Total treatment period is 24 weeks.

Also known as: Vidaza and Revlimid
azacitidine + lenalidomide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age at the time of signing the informed consent form.
  • MDS with IPSS Int-2 or High with a karyotype including del(5q).
  • Acute myeloid leukaemia (AML) with multilineage dysplasia and 20-30 % blasts (former RAEB-t) with a karyotype including del(5q).
  • Subject has signed the informed consent form.
  • Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting lenalidomide. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive methods; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on lenalidomide. WCBP must agree to have pregnancy tests every 4 weeks while on lenalidomide.
  • Males (including those who have had a vasectomy) must use barrier contraception (latex condoms) when engaging in reproductive sexual activity with WCBP while on lenalidomide, when temporarily stopping lenalidomide and 28 days after the last dose of lenalidomide.

You may not qualify if:

  • Eligible for upfront allogeneic SCT without prior induction chemotherapy or azacitidine
  • Pregnant or lactating females.
  • Prior therapy with azacitidine
  • Prior therapy with lenalidomide
  • Expected survival less than two months.
  • Acute promyelocytic leukemia (APL)
  • Central nervous system leukemia
  • Serum biochemical values as follows
  • Serum creatinine \>2.0 mg/dL (177 mmol/L)
  • Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transferase (ALT)/serum glutamate pyruvate transaminase (SGPT) \>3.0 x upper limit of normal (ULN)
  • Serum total bilirubin \>1.5 mg/dL
  • Prior allergic reaction to thalidomide
  • Uncontrolled systemic infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lars Möllgård

Stockholm, 141 86, Sweden

RECRUITING

Related Publications (1)

  • Rasmussen B, Nilsson L, Tobiasson M, Jadersten M, Garelius H, Dybedal I, Gronbaek K, Ejerblad E, Lorenz F, Flogegard M, Marcher CW, Cavalier L, Ebeling F, Olsnes AM, Norgaard JM, Saft L, Mollgard L, Hellstrom-Lindberg E, Schlegelberger B, Gohring G. Influence of Cytogenetics on the Outcome of Patients With High-Risk Myelodysplastic Syndrome Including Deletion 5q Treated With Azacitidine With or Without Lenalidomide. Genes Chromosomes Cancer. 2025 Feb;64(2):e70029. doi: 10.1002/gcc.70029.

    PMID: 39921387DERIVED

Related Links

MeSH Terms

Conditions

Myelodysplastic SyndromesLeukemia, Myeloid, Acute

Interventions

AzacitidineLenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsPiperidonesPiperidinesIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Lars Möllgård, MD, PhD

    Nordic MDS Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lars Möllgård, MD, PhD

CONTACT

+46 8 5858 0000lars.mollgard@karolinska.se

Bengt Rasmussen, MD

CONTACT

+46 19 6021111bengt.rasmussen@orebroll.se

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 16, 2012

Study Start

March 1, 2012

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

SE(1)