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LymphomaPhase 1/2NCT01180569

Lenalidomide Therapy In Previously Untreated, Advanced Stage Follicular Lymphoma

A Phase 1/2 study testing lenalidomide in people with Lymphoma and Follicular Lymphoma, run by Memorial Sloan Kettering Cancer Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration (FDA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular Lymphoma
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
0 participants
Where
No sites listed yet
Study dates
Aug 2010to May 2011
Phase
Phase 1/2
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

  • Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, (as defined in the WHO classification3) as reviewed by a hematopathologist at Memorial Hospital
  • No prior treatment for lymphoma permitted.
  • Measurable or evaluable disease is permitted; at least one peripheral site amenable to FNAs
  • Laboratory test results within these ranges
  • Absolute neutrophil count ≥ 2000
  • Platelet count ≥ 150,000
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  • Creatinine clearance of ≥ 60 mL/min (may be actual or calculated by Cockroft-Gault formula
  • Total bilirubin 1.5 x ULN
  • AST (SGOT) and ALT (SGPT) ≤ 3 x ULN. Karnofsky performance status > 70%
  • The patient may not have a previous history of radiation therapy.
  • Patient or guardian must be able to sign voluntary written consent.
  • Male or female patients 18 years of age or greater.
  • Females of childbearing potential (FCBP)† must have a negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods (Appendix B), and also Appendix C: Education and Counseling Guidance Document.
  • Able to take aspirin (81 mg, if not already on aspirin) daily as prophylactic anticoagulation (Patients intolerant to ASA may use low molecular weight heparin). Although not recommended as prophylactic anti-coagulation, warfin may be used with clode monitoring of INR.

Who cannot join

  • Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.
  • Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.
  • PET uptake in any of the involved sites greater than 12 (suggesting histologic transformation).
  • Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.Staging fulfills criteria for no initial treatment according to GELF criteria2 for advanced stage disease (not peripheral stage I and II amenable to involved field irradiation) . None of the following should be present:
  • A nodal or extranodal mass with a diameter of >7 cm,
  • Involvement of at least three nodal sites [each with a diameter of >3 cm],
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  • Systemic symptoms,
  • Symptomatic splenomegaly, or
  • Ureteral compression.
  • Patients with a known history of HIV, Hepatitis B or C seropositivity.
  • Patients with stool positive for H. Pylori (these patients are eligible for protocol 07-038).
  • Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see Appendix E). Subjects may be enrolled upon correction of electrolyte abnormalities.
  • Patients who require therapy with systemic corticosteroids.
  • Prior history of malignancy within the past five years or a concurrent malignancy, with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix.
  • Pregnant or lactating women.

About this study

The purpose of this study is to see if a treatment with Lenalidomide, which is a pill given by mouth for 7.5 months (30 weeks total), can delay the growth of lymphoma or shrink the lymphoma. Lenalidomide is a pill that has been approved by the Food and Drug Administration (FDA). It is used to treat some forms of cancer-like illnesses (myelodysplastic syndrome (MDS)and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood). This drug works by stimulating the body's immune system and by reducing the blood supply to cancer cells. Cancer cells need blood to live and grow. In this study, the drug is considered a new or experimental drug because we are learning how it works against your form of lymphoma.

Being tested
lenalidomide
Keywords
Lenalidomide, 10-022
Medical subject headings
Lymphoma, Lymphoma, Follicular

What participants receive

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

  • lenalidomideDrug

    Patient enrollment FNA of palpable lymph node prior to escalation phase

    Escalation phase of Lenalidomide:

    Lenalidomide 5 mg daily PO x 14 days Lenalidomide 10 mg daily PO x 14 days Lenalidomide 15 mg daily PO x 14 days Week of rest FNA of palpable lymph node prior to treatment phase

    Treatment phase of Lenalidomide:

    15 mg daily PO days 1-21 out of a 28 day cycle Repeat x 6 cycles

Study groups in NCT01180569
Study groupRoleWhat they receive
lenalidomideExperimentalEligible patients for this clinical trial will be treated for 6 cycles with lenalidomide at 15 mg daily by mouth on Days1-21 of 28 day cycle, preceded by an escalating schema for safety (5mg daily for 2 weeks; 10 mg daily for 2 weeks; and 15 mg daily for 2 weeks) and then a one week rest).
Receives: Drug: lenalidomide

What is being measured

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

  1. Response rate (CR + PR).

    The primary objective of this study is to evaluate lenalidomide in previously untreated patients with advanced stage follicular lymphoma who do not require active lymphoma therapy.

    Measured: 2 years

Secondary outcomes (3)

  1. Response rate (CR + PR) and time to disease progression

    according to FLIPI score. The Follicular Lymphoma International Prognostic Index (FLIPI)

    Measured: 2 years

  2. Immune monitoring and analysis of signal transduction in the lymph node.

    Measured: 2 years

  3. Immune monitoring and analysis of signal transduction in the blood.

    Measured: 2 years

Timeline

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

  1. First posted12 Aug 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionMay 2011
  4. Study completionMay 2011

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01180569
Sponsor's protocol ID
10-022
Status last verified
Sep 2015
First submitted
10 Aug 2010
Last updated
25 Sep 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing lenalidomide in people with Lymphoma and Follicular Lymphoma, run by Memorial Sloan Kettering Cancer Center.

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 14 inclusion and 15 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: withdrawn, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was withdrawn before enrolling participants, so there are no results.

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?

Response rate (CR + PR). (time frame: 2 years). 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 NCT01180569.

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 25 Sep 2015.

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