Leukemia, MyeloidPhase 1UF-BMT-MRD-101NCT02370888
Lenalidomide After Allo-Hematopoietic Cell Transplant (HCT) in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndromes (MDS) Subjects With Minimal Residual Disease
A Phase 1 study testing Lenalidomide in people with Leukemia, Myeloid and Myelodysplastic Syndromes, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leukemia, Myeloid, Myelodysplastic Syndromes
- What is being tested?
- Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2016to 31 May 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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:
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program; and
- Written, voluntary informed consent, willingness, and ability to comply with all study procedures.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Shands Cancer Center
Gainesville, Florida, 32608
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Leukemia, Myeloid, Myelodysplastic Syndromes
- Being tested
- Lenalidomide
- Keywords
- Lenalidomide, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation
- Medical subject headings
- Leukemia, Myeloid, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenalidomideDrug
Also called Revlimid
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 days
Secondary outcomes (1)
CD34+ Mixed Chimerism
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.
Measured: Up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start16 May 2016
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Leukemia, MyeloidStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Maxim N. Norkin, M.D., Ph.D, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02370888
- Sponsor's protocol ID
- WIRB20151509
- Other IDs
- RV-CL-AML-PI-002987
- Acronym
- UF-BMT-MRD-101
- Status last verified
- Jan 2020
- First submitted
- 10 Feb 2015
- Last updated
- 27 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02370888
- Acronym / sponsor ID
- UF-BMT-MRD-101 / WIRB20151509
- Conditions
- Leukemia, Myeloid, Myelodysplastic Syndromes
- Keywords
- Lenalidomide, Hematopoietic Stem Cell Transplantation, Peripheral Blood Stem Cell Transplantation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- 16 May 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lenalidomide | Experimental | Drug: LenalidomideLenalidomide 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Subjects must be at least 18 years of age;
- Subjects must be post-allogeneic transplant from any donor source;
- Subjects must have either:
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LenalidomideAlso: RevlimidSubjects 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. | Drug | Lenalidomide |
Primary outcome
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.
1 secondary outcome
CD34+ Mixed Chimerism
Time frame: Up to 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxim N. Norkin, M.D., Ph.D principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenalidomide in people with Leukemia, Myeloid and Myelodysplastic Syndromes, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) of Lenalidomide (time frame: Up to 72 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.