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Acute Myeloid LeukemiaPhase 1NCT00466895

Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia.

A Phase 1 study testing lenalidomide in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Leslie Andritsos at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase I Study of Lenalidomide in Acute Leukemias and Chronic Lymphocytic Leukemia. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Apr 2007to Jul 2016
Phase
Phase 1
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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

Read the detailed description

Rationale:

Lenalidomide has properties of thalidomide and appears to have some activity against cancer in laboratory tests. Researchers are still learning how lenalidomide works against cancer in patients. Some ways that this drug seems to produce anti-cancer effects include through stimulating the immune system and blocking blood vessels contributing to cancer growth. The current study will explore different dose levels in patients to gather more information about lenalidomide.

Purpose:

This study will assess the maximum tolerated dose of lenalidomide in patients with relapsed or refractory acute leukemias and chronic lymphocytic leukemias. Toxicity or side effects within patients will also be evaluated. Other purposes of this study include analyzing preliminary clinical activity, pharmacokinetics, and pharmacodynamics. Pharmacokinetics refers to the activity of drugs in the body over a period of time, including how drugs are absorbed, distributed, localized in tissues, and excreted. Pharmacodynamics refers to the bodily processes that lead the drug to effect cancer and other cellular components in the body.

Treatment:

Study participants will be given lenalidomide through intravenous infusions once every 28 days. A 28-day period constitutes a cycle. Since this study will assess the maximum tolerated dose of lenalidomide, some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study. Each group of 3 to 6 study participants will receive a higher dose of lenalidomide until the maximum tolerated dose is established. Several tests will be performed throughout the study, including bone marrow biopsies. Imaging exams will be conducted as well. Treatments will be discontinued due to disease growth or intolerable adverse effects. Lenalidomide administration will be repeated for 12 or more cycles in patients that experience clinical benefit.

Being tested
lenalidomide
Keywords
Leukemia, Lenalidomide
Medical subject headings
Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenalidomideDrug

    Also called Revlimid

    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

Study groups in NCT00466895
Study groupRoleWhat they receive
Stratum 1 Acute LeukemiasExperimentalPatients must have a diagnosis of Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia(ALL)according to the WHO (World Health Organization) classification.
Receives: Drug: lenalidomide
Stratum 2 Chronic lymphocytic leukemiaExperimentalPatients 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.
Receives: Drug: lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerable dose

    Measured: Every 2 weeks during cycle 1; Monthly during subsequent cycles

  2. Toxicities of lenalidomide

    Measured: Every 2 weeks during cycle 1; Monthly for subsequent cycles

Secondary outcomes (3)

  1. preliminary clinical activity

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

  2. plasma and cellular pharmacokinetics

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

  3. pharmacodynamics

    Measured: Days 1, 8 and 26.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Apr 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionDec 2014
  4. Study completionJul 2016

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00466895
Sponsor's protocol ID
OSU-06003
Other IDs
NCI-2011-03218
Status last verified
Nov 2017
First submitted
26 Apr 2007
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25082342

  • 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.

    PubMed 19965642

  • 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.

    PubMed 18824593

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lenalidomide in people with Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Leslie Andritsos 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2017. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 tolerable dose (time frame: Every 2 weeks during cycle 1; Monthly during subsequent cycles). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00466895, which also lists 3 linked publications.

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 14 Nov 2017.

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