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B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt LymphomaPhase 1NCT01722305

Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma

A Phase 1 study testing Dexamethasone, Laboratory Biomarker Analysis and Pharmacological Study in people with B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma and Central Nervous System Lymphoma, run by Mayo Clinic at 7 sites 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

This phase I trial studies the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dexamethasone, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
7 sitesUnited States
Study dates
8 Apr 2013to 15 Jul 2019
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

  • Relapsed or refractory primary central nervous system (CNS) diffuse large B cell lymphoma (PCNSDLBCL) with a CNS lesion, with cerebrospinal fluid (CSF) relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy is not absolutely necessary for CNS tumor unless clinical and radiologic findings strongly suggest other etiologies as per treating physician; initial diagnosis must be made by tissue biopsy; NOTE: patients with B-cell lymphoma with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma are also eligible for the protocol as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible
  • Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a CNS lesion, with CSF relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy requirement of the CNS lesion is as outlined in bullet above
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, 2 or 3
  • Absolute neutrophil count (ANC) >= 1000/uL
  • Platelets (PLT) >= 100,000/uL
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) or if total bilirubin is > 1.5 x ULN the direct bilirubin must be =< 1.5 x ULN (=< 0.45 mg/dL)
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  • Aspartate aminotransferase (AST) =< 3 x ULN
  • Creatinine =< 2.5 x ULN
  • Females of reproductive potential must be willing to adhere to the scheduled pregnancy testing as required in the POMALYST REMS (TM) program
  • Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to acetylsalicylic acid [ASA] may use warfarin or heparin)
  • Provide informed written consent
  • Willing to return to participating medical institutions for follow-up
  • Willing to provide tissue samples for correlative research purposes
  • Willing to be registered into the mandatory POMALYST REMS (TM) program, and willing and able to comply with the requirements of the POMALYST REMS (TM) program

Who cannot join

  • Any of the following
  • Pregnant women
  • Nursing women
  • Men or women of childbearing potential who are unwilling to employ adequate contraception
  • The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
  • Uncontrolled infection
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  • Therapy with myelosuppressive chemotherapy or biologic therapy < 21 days prior to registration; NOTE: patients who have recovered from cytopenia related to previous treatment and meet criteria of this protocol will be eligible
  • Persistent toxicities >= grade 3 from prior chemotherapy or biological therapy regardless of interval since last treatment
  • History of thromboembolic episodes =< 3 months prior to registration
  • Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration [FDA]-approved indication and in the context of a research investigation)
  • Immunodeficiency states including human immunodeficiency virus (HIV) infection
  • Active hepatitis B or C with uncontrolled disease; NOTE: a detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B core immunoglobulin M antibody (HBcIgM Ab), hepatitis B surface antigen (HBsAg) and hepatitis C antibody screen (HCV Ab Scrn) w/reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B (HBV) infection
  • Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
  • Inability to swallow or impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) that would preclude use of oral medications
  • Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study
  • Major surgery =< 4 weeks prior to registration or have not recovered from side effects of such therapy
  • New York Heart Association classification III or IV

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Dana-Farber Harvard Cancer Center

    Boston, Massachusetts, 02115

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma

This phase I trial studies the side effects and best dose of pomalidomide when given together with dexamethasone in treating patients with primary central nervous system lymphoma that has come back (relapsed) or does not respond to treatment (refractory) or intraocular lymphoma that is newly diagnosed, relapsed or refractory. Pomalidomide may stimulate the immune system to kill cancer cells. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, stopping them from dividing, or by stopping them from spreading. Giving pomalidomide together with dexamethasone may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the maximum tolerated dose (MTD) of pomalidomide in combination with dexamethasone in patients with relapsed/refractory primary central nervous system lymphoma (PCNSL) or primary vitreoretinal lymphoma (PVRL).

SECONDARY OBJECTIVES:

  1. To evaluate the efficacy (overall response rate) and safety of pomalidomide in combination with dexamethasone in patients with PCNSL and PVRL lymphoma in an MTD expanded cohort.

II. To evaluate overall survival and progression free survival.

TERTIARY OBJECTIVES:

  1. To study the pharmacokinetics of pomalidomide in the central nervous system. II. To identify the predictive biomarkers for responsiveness to pomalidomide.

OUTLINE: This is a dose-escalation study of pomalidomide.

Patients receive pomalidomide orally (PO) on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years.

Being tested
Dexamethasone, Laboratory Biomarker Analysis, Pharmacological Study, Pomalidomide
Medical subject headings
Lymphoma, B-Cell, Burkitt Lymphoma, Intraocular Lymphoma, Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • DexamethasoneDrug

    Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex

    Given PO

  • Laboratory Biomarker AnalysisOther

    Optional correlative studies

  • Pharmacological StudyOther

    Optional correlative studies

  • PomalidomideDrug

    Also called 4-Aminothalidomide, Actimid, CC-4047, Imnovid

    Given PO

Study groups in NCT01722305
Study groupRoleWhat they receive
Treatment (pomalidomide, dexamethasone)ExperimentalPatients receive pomalidomide PO on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22 of courses 1 and 2. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Dexamethasone; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Drug: Pomalidomide

What is being measured

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

  1. MTD of pomalidomide when given in combination with dexamethasone determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0

    The number and severity of all adverse events will be tabulated and summarized in this patient population both overall and by dose level. The grade 3+ adverse events will also be described and summarized in a similar fashion. Overall toxicity incidence as well as toxicity profiles by dose level and patient will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses.

    Measured: 28 days

Secondary outcomes (4)

  1. Incidence of adverse events, graded according to CTCAE 4.0

    The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

    Measured: Up to 30 days post-treatment

  2. Overall response rate defined as number of patients with an objective status of complete response (CR), complete response/unconfirmed (Cru), or partial response (PR) divided by total number of evaluable patients

    Exact binomial 95% confidence intervals for the true overall response rate will be calculated.

    Measured: Up to 2 years

  3. Overall survival time

    The distribution of overall survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to death due to any cause, assessed up to 2 years

  4. Progression-free survival

    The distribution of progression-free survival will be estimated using the method of Kaplan-Meier.

    Measured: Time from registration to progression or death due to PCNSL or PVRL lymphoma, assessed up to 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 posted6 Nov 2012 (estimated)
  2. Study start8 Apr 2013
  3. Primary completion3 Jun 2016
  4. Study completion15 Jul 2019

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722305
Sponsor's protocol ID
MC1281
Other IDs
NCI-2012-01948, MC1281, P30CA015083
Status last verified
Jul 2019
First submitted
2 Nov 2012
Last updated
22 Jul 2019
Results posted
No
Data monitoring committee
No

Publications

  • Tun HW, Johnston PB, DeAngelis LM, Atherton PJ, Pederson LD, Koenig PA, Reeder CB, Omuro AMP, Schiff D, O'Neill B, Pulido J, Jaeckle KA, Grommes C, Witzig TE. Phase 1 study of pomalidomide and dexamethasone for relapsed/refractory primary CNS or vitreoretinal lymphoma. Blood. 2018 Nov 22;132(21):2240-2248. doi: 10.1182/blood-2018-02-835496. Epub 2018 Sep 27.

    PubMed 30262659

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dexamethasone, Laboratory Biomarker Analysis and Pharmacological Study in people with B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma and Central Nervous System Lymphoma, run by Mayo Clinic at 7 sites 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 14 inclusion and 17 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 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

MTD of pomalidomide when given in combination with dexamethasone determined by dose-limiting toxicities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 (time frame: 28 days). 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 NCT01722305, which also lists 1 linked publication.

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 22 Jul 2019.

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