Pomalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma or Newly Diagnosed or Relapsed or Refractory Intraocular Lymphoma
Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma
3 other identifiers
interventional
29
1 country
7
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2013
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2012
CompletedFirst Posted
Study publicly available on registry
November 6, 2012
CompletedStudy Start
First participant enrolled
April 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2019
CompletedJuly 22, 2019
July 1, 2019
3.2 years
November 2, 2012
July 18, 2019
Conditions
Outcome Measures
Primary Outcomes (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.
28 days
Secondary Outcomes (4)
Incidence of adverse events, graded according to CTCAE 4.0
Up to 30 days post-treatment
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
Up to 2 years
Overall survival time
Time from registration to death due to any cause, assessed up to 2 years
Progression-free survival
Time from registration to progression or death due to PCNSL or PVRL lymphoma, assessed up to 2 years
Other Outcomes (2)
Pharmacokinetics of pomalidomide in the CNS
Up to day 22 of course 1
Predictive biomarkers for response to pomalidomide
Up to day 21 of course 1
Study Arms (1)
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.
Interventions
Given PO
Optional correlative studies
Given PO
Eligibility Criteria
You may qualify if:
- 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)
- 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
You may not qualify if:
- 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
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (7)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Dana-Farber Harvard Cancer Center
Boston, Massachusetts, 02115, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
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.
PMID: 30262659DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Han Tun
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2012
First Posted
November 6, 2012
Study Start
April 8, 2013
Primary Completion
June 3, 2016
Study Completion
July 15, 2019
Last Updated
July 22, 2019
Record last verified: 2019-07