NCT01254578

Brief Summary

This phase I clinical trial is studying the side effects and the best dose of lenalidomide after donor bone marrow transplant in treating patients with high-risk hematologic cancer. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2010

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

November 24, 2010

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 3, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2012

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

December 3, 2010

Last Update Submit

September 22, 2017

Conditions

Adult Acute Myeloid Leukemia in RemissionAdult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2AAdult Acute Promyelocytic Leukemia With PML-RARAAdult Grade III Lymphomatoid GranulomatosisAdult Nasal Type Extranodal NK/T-Cell LymphomaAlkylating Agent-Related Acute Myeloid LeukemiaAnaplastic Large Cell LymphomaAngioimmunoblastic T-Cell LymphomaExtranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid TissueHepatosplenic T-Cell LymphomaIntraocular LymphomaLymphomatous Involvement of Non-Cutaneous Extranodal SiteMature T-Cell and NK-Cell Non-Hodgkin LymphomaNodal Marginal Zone LymphomaPost-Transplant Lymphoproliferative DisorderPrimary Cutaneous B-Cell Non-Hodgkin LymphomaProlymphocytic LeukemiaRecurrent Adult Burkitt LymphomaRecurrent Adult Grade III Lymphomatoid GranulomatosisRecurrent Adult Immunoblastic LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-Cell Leukemia/LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Marginal Zone LymphomaRecurrent Mycosis Fungoides and Sezary SyndromeRecurrent Non-Hodgkin LymphomaRecurrent Primary Cutaneous T-Cell Non-Hodgkin LymphomaRecurrent Small Lymphocytic LymphomaRefractory Chronic Lymphocytic LeukemiaRefractory Hairy Cell LeukemiaRichter SyndromeSmall Intestinal LymphomaSplenic Marginal Zone LymphomaT-Cell Large Granular Lymphocyte LeukemiaTesticular LymphomaWaldenstrom Macroglobulinemia

Outcome Measures

Primary Outcomes (1)

  • MTD of lenalidomide after allogeneic hematopoietic stem cell transplantation graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0

    Up to day 28

Secondary Outcomes (1)

  • Overall response in patients treated with lenalidomide according to the International Working Group (IWG) criteria

    Up to day 365

Study Arms (1)

Treatment (lenalidomide)

EXPERIMENTAL

Patients receive oral lenalidomide once daily on days 1-28. Courses repeat every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity. Patients undergo blood and bone marrow biopsies and aspirate collection at baseline and periodically during study for pharmacokinetic and pharmacodynamic studies. Buccal swab samples are also collected at baseline and analyzed for genetic polymorphisms.

Other: Laboratory Biomarker AnalysisDrug: LenalidomideOther: Pharmacological Study

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Treatment (lenalidomide)
LenalidomideDRUG

Given orally

Also known as: CC-5013, CC5013, CDC 501, Revlimid
Treatment (lenalidomide)
Pharmacological StudyOTHER

Correlative studies

Treatment (lenalidomide)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed hematologic malignancy meeting 1 of the following criteria:
  • High-risk acute myeloid leukemia meeting 1 the following criteria:
  • First complete response (CR) and ≥ 60 years of age OR \< 60 years of age with high-risk cytogenetics as defined by CALGB OR high-molecular risk and not eligible or willing to undergo myeloablative conditioning
  • Second or later complete remission
  • Not in remission but with \< 5% blasts within 3 weeks of start of conditioning chemotherapy for allogeneic transplantation
  • Patients with a history of CNS involvement allowed provided disease is in remission at the time of transplantation
  • Patients with non-Hodgkin lymphoma who are candidates for allogeneic stem cell transplantation will be eligible; patients who have relapsed status post autologous transplantation are eligible as long as they demonstrate chemotherapy sensitive disease; patients with a history of CNS involvement are eligible if this aspect of the disease is in remission at the time of transplantation
  • High-risk chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or primary and secondary B-prolymphocytic leukemia (PLL) meeting 1 of the following criteria:
  • del(17p13.1) disease that has been treated (may have been given as consolidation therapy)
  • Less than PR to chemoimmunotherapy or relapsed within 2 years of treatment
  • Nucleoside analog refractory disease or disease that relapsed after two prior regimens
  • Patients with Richter (large cell) transformation allowed provided the large cell component of the disease is in remission (\< 10% large cells in the bone marrow allowed)
  • Patient has undergone an allogeneic stem cell transplantation using a reduced-intensity or non-myeloablative conditioning regimen within the past 60 days
  • At least 40% T-cell donor chimerism at day 30
  • ECOG performance status 0-2 (Karnofsky 60-100%)
  • +24 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Leukemia, Myelomonocytic, AcuteLeukemia, Promyelocytic, AcuteLymphoma, Extranodal NK-T-CellLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyLymphoma, B-Cell, Marginal ZoneIntraocular LymphomaLymphoma, T-CellLeukemia, ProlymphocyticBurkitt LymphomaLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellMycosis FungoidesSezary SyndromeLymphoma, Non-HodgkinLymphoma, T-Cell, CutaneousLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Hairy CellLeukemia, Large Granular LymphocyticWaldenstrom Macroglobulinemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid, AcuteLymphomaLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathyLymphoma, B-CellEye NeoplasmsNeoplasms by SiteLeukemia, LymphoidEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, T-CellNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Leslie Andritsos

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2010

First Posted

December 6, 2010

Study Start

November 24, 2010

Primary Completion

November 9, 2012

Study Completion

November 9, 2012

Last Updated

September 25, 2017

Record last verified: 2017-09

Locations

US(1)