Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

NCT00466895 | Completed Phase 1 DMC

• 2 other identifiers: OSU-06003NCI-2011-03218
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Chronic Lymphocytic Leukemia

Keywords

Leukemia; Lenalidomide

Outcome Measures

Primary Outcomes (2)

• Maximum tolerable dose

  Every 2 weeks during cycle 1; Monthly during subsequent cycles

• Toxicities of lenalidomide

  Every 2 weeks during cycle 1; Monthly for subsequent cycles

Secondary Outcomes (3)

• preliminary clinical activity

  Twice weekly during cycle 1; Weekly during cycles 2-6; Monthly thereafter

• plasma and cellular pharmacokinetics

  Days 1, 8, 15 and 21 of first cycle.

• pharmacodynamics

  Days 1, 8 and 26.

Study Arms (2)

Stratum 1 Acute Leukemias

EXPERIMENTAL

Patients must have a diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia(ALL)according to the WHO (World Health Organization) classification.

Drug: lenalidomide

Stratum 2 Chronic lymphocytic leukemia

EXPERIMENTAL

Patients must have diagnosis of B-Cell, Chronic Lymphocytic Leukemia(CLL) or Small Lymphocytic Leukemia (SLL) (including Waldenstrom's Macroglobulinemia) requiring therapy (see eligibility criteria for definition of this) and have previously received treatment with one or more prior chemotherapy regimens.

Drug: lenalidomide

Interventions

lenalidomide DRUG

Dose level -1: 2.5 mg daily for days 1-7, 2.5 mg daily for days 8-21. Dose level 1: 2.5 mg daily for days 1-7, 5 mg daily for days 8-21. Dose level 2: 2.5 mg daily for days 1-7, 7.5 mg daily for days 8-21. Dose level 3: 2.5 mg daily for days 1-7, 10 mg daily for days 8-21. Dose level 4: 2.5 mg daily for days 1-7, 15 mg daily for days 8-21

Also known as: Revlimid

Stratum 1 Acute Leukemias; Stratum 2 Chronic lymphocytic leukemia

Eligibility Criteria

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

You may qualify if:

• Blood blast count must be \< 40,000/uL prior to initiation of therapy. Hydroxyurea (up to 6g/day) may be administered prior to initiation of therapy and during the first week to maintain blood blast count \< 40,000/uL
• ECOG(Eastern Cooperative Oncology Group)performance status 0-2.
• Patients with CNS(central nervous system)involvement will be considered eligible for this study if no residual leukemic cells are detected in the CSF (cerebrospinal fluid)following intrathecal chemotherapy or radiation.

You may not qualify if:

• Patients with acute promyelocytic leukemia are excluded unless patient has failed salvage therapy with arsenic.
• Patients with HIV are excluded due to increased risk of infectious complications, marrow suppression, and potential interactions with antiviral therapy.
• CLL patients who have had chemotherapy (with the exception of hydroxyurea) or radiotherapy within 4 weeks prior to entering the study are excluded. CLL patients receiving corticosteroids (within 2 weeks) for treatment of disease (other than autoimmune manifestations of CLL) are not eligible.
• Patients who have received mitomycin C or nitrosourea require a six weeks recovery period before they can be enrolled on the current study.
• Patients with the following abnormal clinical values are excluded (unless abnormalities in these parameters are directly attributable to malignancy): Serum creatinine \>2.0 mg/dl Total bilirubin \> 2 x upper limit of normal (unless due to Gilbert's syndrome) ALT and AST \> 5 x upper limit of normal

Sponsors & Collaborators

• Leslie Andritsos: lead
• Celgene Corporation: collaborator

Study Sites (1)

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• Maddocks K, Ruppert AS, Browning R, Jones J, Flynn J, Kefauver C, Gao Y, Jiang Y, Rozewski DM, Poi M, Phelps MA, Harper E, Johnson AJ, Byrd JC, Andritsos LA. A dose escalation feasibility study of lenalidomide for treatment of symptomatic, relapsed chronic lymphocytic leukemia. Leuk Res. 2014 Sep;38(9):1025-9. doi: 10.1016/j.leukres.2014.05.011. Epub 2014 May 29.

  PMID: 25082342 RESULT

• Lapalombella R, Andritsos L, Liu Q, May SE, Browning R, Pham LV, Blum KA, Blum W, Ramanunni A, Raymond CA, Smith LL, Lehman A, Mo X, Jarjoura D, Chen CS, Ford R Jr, Rader C, Muthusamy N, Johnson AJ, Byrd JC. Lenalidomide treatment promotes CD154 expression on CLL cells and enhances production of antibodies by normal B cells through a PI3-kinase-dependent pathway. Blood. 2010 Apr 1;115(13):2619-29. doi: 10.1182/blood-2009-09-242438. Epub 2009 Nov 24.

  PMID: 19965642 DERIVED

• Fehniger TA, Byrd JC, Marcucci G, Abboud CN, Kefauver C, Payton JE, Vij R, Blum W. Single-agent lenalidomide induces complete remission of acute myeloid leukemia in patients with isolated trisomy 13. Blood. 2009 Jan 29;113(5):1002-5. doi: 10.1182/blood-2008-04-152678. Epub 2008 Sep 29.

  PMID: 18824593 DERIVED

Related Links

• Jamesline

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leslie Andritsos, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2007
• First Posted: April 27, 2007
• Study Start: April 1, 2007
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2016
• Last Updated: November 14, 2017

Record last verified: 2017-11

Locations

US (1)