Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease

NCT02370888 | Terminated Phase 1 Results DMC FDA Drug

• 2 other identifiers: WIRB20151509RV-CL-AML-PI-002987
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the maximum tolerated dose, dose limiting side effects, and the safety of increasing doses of lenalidomide in patients with AML and MDS who have a small amount of detectable disease after allogeneic stem cell transplant.

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes

Keywords

Lenalidomide; Hematopoietic Stem Cell Transplantation; Peripheral Blood Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of Lenalidomide

  To determine safety and the maximum tolerated dose of lenalidomide after allo-HCT in AML and MDS subjects with MRD detected by the CD34+ mixed chimerism analysis.

  Up to 72 days

Secondary Outcomes (1)

• CD34+ Mixed Chimerism

  Up to 120 days

Study Arms (1)

Lenalidomide

EXPERIMENTAL

Lenalidomide will be administered for a total of 42 days. The dose levels of lenalidomide will be as follows: * Dose Level 1: 2.5 mg PO QOD Day 1-21 for 28-day cycle X 2 cycles * Dose Level 2: 2.5 mg PO QD Day 1-21 for 28-day cycle X 2 cycles * Dose Level 3: 5 mg PO QD Day 1-21 for 28-day cycle X 2 cycles * Dose Level 4: 7.5 mg PO QD Day 1-21 for 28-day cycle X 2 cycles

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles. The starting dose will be 2.5 mg given orally every other day for 21 days.

Also known as: Revlimid

Lenalidomide

Eligibility Criteria

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

You may qualify if:

• Subjects must be at least 18 years of age;
• Subjects must be post-allogeneic transplant from any donor source;
• Subjects must have either:
• High risk CD34+ AML (de novo or secondary, and any WHO 2008 classification excluding acute promyelocytic leukemia). High risk AML is defined as (a) disease status beyond complete remission (CR) #1 at transplant or (b) treatment related AML or (c) presence of adverse cytogenetics including inv(3); t(3;3); t(6;9); t(v;11); -5 or del(5q); -7; abnl(17p) or complex karyotype; or
• High risk CD34+ MDS (WHO 2008 classification). High risk is defined as (a) blast count ≥5% at the time of transplant or (b) treatment related MD or (c) presence of adverse cytogenetics including -7/del7q or complex karyotype;
• For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;
• For MDS subjects, they must have \< 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT;
• Subject Karnofsky performance status must be ≥ 70;
• Subjects must be platelet transfusion independent (Platelet transfusion independence is defined as 7 days or greater without a platelet transfusion);
• Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3;
• Subjects must have total bilirubin ≤ 2 mg/dL;
• Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal;
• Subjects must have serum creatinine \< 2.5 times upper limit of normal and a calculated creatinine clearance \> 30 ml/min by Cockcroft-Gault formula (see Appendix I: Cockcroft-Gault Creatinine Clearance Calculation);
• All study participants who will receive lenalidomide based on the CD34+ chimerism testing must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program;
• Females of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) may participate, provided they meet the following conditions:

You may not qualify if:

• CD34- AML or MDS;
• Inability to give informed consent;
• Uncontrolled active infection(s) requiring intravenous antibiotics;
• Known or suspected hypersensitivity to lenalidomide;
• Grade II-IV acute GVHD or extensive GVHD;
• Not able to swallow the lenalidomide capsule as a whole;
• Female subjects who are pregnant or nursing.

Sponsors & Collaborators

• University of Florida: lead
• Celgene Corporation: collaborator

Study Sites (1)

University of Florida Shands Cancer Center

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid; Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

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

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

Results Point of Contact

• Title: Archana Narasanna, Project Manager
• Organization: Univeristy of Florida Health Cancer Center

PMO@cancer.ufl.edu

(352) 273-6772

Study Officials

• Maxim N. Norkin, M.D., Ph.D

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 25, 2015
• Study Start: May 16, 2016
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: January 27, 2020
• Results First Posted: January 13, 2020

Record last verified: 2020-01

Locations

US (1)