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Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease (UF-BMT-MRD-101)

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ClinicalTrials.gov Identifier: NCT02370888
Recruitment Status : Terminated (Slow accrual)
First Posted : February 25, 2015
Last Update Posted : August 26, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE February 10, 2015
First Posted Date  ICMJE February 25, 2015
Last Update Posted Date August 26, 2019
Actual Study Start Date  ICMJE May 16, 2016
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
Maximum tolerated dose (MTD) of lenalidomide [ Time Frame: Up to 72 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
Maximum tolerated dose (MTD) of lenalidomide [ Time Frame: Up to 72 days ]
To determine the safety, tolerability and maximum dose of lenalidomide in AML and MDS patients after allo-HCT who have minimum residual disease (MRD).
Change History Complete list of historical versions of study NCT02370888 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2017)
CD34+ mixed chimerism [ Time Frame: Up to 120 days ]
To monitor changes in the CD34+ mixed chimerism after allo-HCT in AML and MDS subjects with detectable MRD in response to escalating doses of lenalidomide.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
CD34+ mixed chimerism [ Time Frame: Up to 120 days ]
To determine the effect of lenalidomide in escalating doses on the CD34+ mixed chimerism in AML and MDS patients after allo-HCT allo-HCT who have minimum residual disease (MRD).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease
Official Title  ICMJE A Phase I Clinical Trial to Evaluate the Maximally Tolerated Dose (MTD), Dose Limiting Toxicities (DLTs) and Safety Profiles of Increasing Doses of Lenalidomide After Allo-HCT in AML and MDS Subjects With Minimal Residual Disease (MRD) Detected by the CD34+ Mixed Chimerism Analysis (UF-BMT-MRD-101)
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.
Detailed Description

All subjects entering the screening phase will receive a unique subject number. This number will be used to identify the subject throughout the study. Additional test to include: physical examinations, blood tests, and if applicable pregnancy test will be performed as part of participation in this research study.

Lenalidomide will be administered for a total of 42 days. The starting dose will be 2.5 mg given orally every other day on days 1-21 of a 28-day cycle for 2 cycles. Dose escalations and de-escalations will be made until the maximum tolerated dose is reached.

The dose levels of lenalidomide will be as follows:

Dose Level 1: 2.5 mg

Dose Level 2: 2.5 mg

Dose Level 3: 5 mg

Dose Level 4: 7.5 mg

Doses should be taken at approximately the same time each day.

Subjects must be instructed to swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules.

Each subject will keep an accurate record of lenalidomide dosing on the Subject Dosing Diary. This diary will be kept in the research record as source documentation of lenalidomide dosing. Study personnel will review the dosing instructions with each subject at each study visit. Subjects will be asked to bring any unused drug and empty drug containers to the study site at the next visit for reconciliation with the Subject Dosing Diary.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
Intervention  ICMJE Drug: Lenalidomide
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.
Other Name: Revlimid
Study Arms  ICMJE Experimental: Lenalidomide

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
Intervention: Drug: Lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2019)
11
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
24
Actual Study Completion Date  ICMJE May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must be at least 18 years of age;
  2. Subjects must be post-allogeneic transplant from any donor source;
  3. Subjects must have either:

    1. 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
    2. 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;
  4. For AML subjects, they must have a documented CR within 45 days prior to allo-HCT;
  5. For MDS subjects, they must have < 20% myeloblasts in the bone marrow within 45 days prior to allo-HCT;
  6. Subject Karnofsky performance status must be ≥ 70;
  7. Subjects must be platelet transfusion independent (Platelet transfusion independence is defined as 7 days or greater without a platelet transfusion);
  8. Neutrophil count ≥ 1.0 thou/mm3 and platelet count ≥ 30 thou/mm3;
  9. Subjects must have total bilirubin ≤ 2 mg/dL;
  10. Subjects must have serum AST and ALT levels ≤ 2.5 times upper limit of normal;
  11. 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);
  12. 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;
  13. Females of child-bearing potential (i.e., women who are premenopausal or not surgically sterile) may participate, provided they meet the following conditions:

    a) Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; and

  14. Written, voluntary informed consent, willingness, and ability to comply with all study procedures.

Exclusion Criteria:

  1. CD34- AML or MDS;
  2. Inability to give informed consent;
  3. Uncontrolled active infection(s) requiring intravenous antibiotics;
  4. Known or suspected hypersensitivity to lenalidomide;
  5. Grade II-IV acute GVHD or extensive GVHD;
  6. Not able to swallow the lenalidomide capsule as a whole;
  7. Female subjects who are pregnant or nursing.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02370888
Other Study ID Numbers  ICMJE WIRB20151509
RV-CL-AML-PI-002987 ( Other Grant/Funding Number: Celgene Corporation )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Maxim N. Norkin, M.D., Ph.D University of Florida
PRS Account University of Florida
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP