CLINICAL TRIAL

Lorlatinib for Lymphoma

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Boston, MA

Lorlatinib Combinations in Lung Cancer

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About the trial for Lymphoma

Eligible Conditions
Relapsed Cancer · Lung Cancers · Lung Neoplasms · Lymphoma · ROS1 Rearrangement · Anaplastic Lymphoma Kinase Gene Translocation · MET Amplification · Resistant Cancer · Non-Small Cell Lung Carcinoma (NSCLC)

Treatment Groups

This trial involves 3 different treatments. Lorlatinib is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Lorlatinib
DRUG
+
Crizotinib
DRUG
Experimental Group 2
Lorlatinib
DRUG
+
Binimetinib
DRUG
Experimental Group 3
Lorlatinib
DRUG
+
TNO155
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lorlatinib
FDA approved
Binimetinib
FDA approved
Crizotinib
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must have recovered from treatment toxicities to ≤ Grade 1 or to their pretreatment levels except for adverse events that in the investigator's judgment do not constitute a safety risk for the patient.
Ability to understand and the willingness to sign a written informed consent document.
Age ≥ 18 years.
Histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (Stage IV, AJCC v7.0) that carries an ALK or ROS1 rearrangement (ROS1-positive patients will only be allowed in dose escalation) as determined using a local diagnostic test or a commercial test or by the Food and Drug Administration (FDA)-approved FISH test, using Vysis® ALK Break apart FISH Probe, or the Ventana® immunohistochemistry (IHC) test.
Disease progression or intolerance to at least one tyrosine kinase inhibitor At least one measurable lesion as defined by RECIST version 1.1. Previously irradiated lesions are not measurable unless the lesion has demonstrated clear progression after radiation.
ECOG performance status ≤ 2
Life expectancy of greater than 12 weeks
Patients must be willing to undergo serial biopsies and have disease accessible to pretreatment biopsy. A cell block from a pleural effusion or ascites may be substituted for a core biopsy. In select cases, patients may be allowed to enroll without a pre-treatment biopsy and/or continue treatment without an on-treatment biopsy after speaking with the Overall Principal Investigator if performing the biopsy is technically challenging, poses significant risk to the patient, or may result in significant discomfort. If a pre-treatment biopsy is not performed, archival tissue will be used for correlative studies, specifically plasma-tissue comparisons.
Able to swallow and retain orally administered medication. Does not have any clinically significant gastrointestinal abnormalities, such as malabsorption syndrome or major resection of the stomach or small bowel that may alter absorption of the medication.
A minimum washout period of 5 days or 5 half-lives between the last dose of tyrosine kinase inhibitor therapy and the first dose of study treatment is required (whichever is shorter). A shorter washout period may be considered in the event of disease flare, after discussion with the Overall Principal Investigator. No washout is required if the most recent anti-neoplastic therapy is lorlatinib.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 24 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 24 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Lorlatinib will improve 2 primary outcomes and 3 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 28 days (binimetinib and crizotinib arm), 21 days (TNO155 arm).

Maximum tolerated dose as assessed by CTCAE v5.0. Phase I.
28 DAYS (BINIMETINIB AND CRIZOTINIB ARM), 21 DAYS (TNO155 ARM)
The highest dose of the combinations that does not cause unacceptable side effects. The maximum tolerated dose is determined in clinical trials by testing increasing doses in different groups of patients until the highest dose with acceptable side effects is found.
28 DAYS (BINIMETINIB AND CRIZOTINIB ARM), 21 DAYS (TNO155 ARM)
Duration of Response to Treatment as Assessed by RECIST v1.1
MEASURED FROM THE TIME MEASUREMENT CRITERIA ARE MET FOR COMPLETE OR PARTIAL RESPONSE UNTIL THE FIRST DATE THAT RECURRENT OR PROGRESSIVE DISEASE IS OBJECTIVELY DOCUMENTED OR THE DATE OF DEATH DUE TO ANY CAUSE, LIKELY AVERAGE OF 12 MONTHS
Duration of response to treatment is measured from the time that measurement criteria (RECIST v1.1) are met for complete response or partial response (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), or death due to any cause.
MEASURED FROM THE TIME MEASUREMENT CRITERIA ARE MET FOR COMPLETE OR PARTIAL RESPONSE UNTIL THE FIRST DATE THAT RECURRENT OR PROGRESSIVE DISEASE IS OBJECTIVELY DOCUMENTED OR THE DATE OF DEATH DUE TO ANY CAUSE, LIKELY AVERAGE OF 12 MONTHS
Progression-Free Survival as assessed by RECIST v1.1 and the Kaplan-Meier Method
TIME FROM THE START OF STUDY DRUG TREATMENT TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION OR DEATH DUE TO DISEASE, LIKELY AVERAGE OF 12 MONTHS
PFS will defined as the time from the start of treatment to the date of the first documented progression or death due to disease. The distribution of PFS will be estimated using the Kaplan-Meier method.
TIME FROM THE START OF STUDY DRUG TREATMENT TO THE DATE OF THE FIRST DOCUMENTED PROGRESSION OR DEATH DUE TO DISEASE, LIKELY AVERAGE OF 12 MONTHS
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE V5.0
FROM FIRST DOSE TO END OF STUDY. TIME FRAME IS ANTICIPATED TO BE 24 MONTHS.
Number of patients with treatment-related side effects, according to CTCAE v5.0
FROM FIRST DOSE TO END OF STUDY. TIME FRAME IS ANTICIPATED TO BE 24 MONTHS.
The objective response rate, including partial and complete responses, as evaluated by RECIST v1.1. Phase II
24 MONTHS
Objective response rate (partial and complete responses) will be evaluated according to RECIST v1.1 criteria.
24 MONTHS

Who is running the study

Principal Investigator
I. D. M.
Ibiayi Dagogo-Jack M.D., Principal Investigator
Massachusetts General Hospital

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lymphoma?

Lymphoma is a cancer of lymph nodes. Most cases of lymphoma are Non-Hodgkin's B-cell lymphomas, and non-Hodgkin's lymphoma is the most common cause of death from malignant disease in males aged 15 to 20 years.

Anonymous Patient Answer

What are the signs of lymphoma?

  • Lymphoma of the head and neck should be considered in patients with unexplained swelling, especially painless of the neck.\n- Involvement of more than one lymph node area, and/or a large lymph node on CT or ultrasound scan are indicative of larger pathology and the need for excisional biopsy.\n- Elevated LDH should prompt further investigation for a lymphoma, particularly nodular lymphoma.\n- Liver abnormalities indicate an involvement that requires biopsy.
Anonymous Patient Answer

What causes lymphoma?

Chronic immune system activation may have a role in some lymphomas, particularly in mantle cell lymphoma. Chronic immune activation may lead to higher levels of inflammation, which may be accompanied by increased proliferation of malignant cells, leading to lymphoma. Immune system activation as a driver of lymphomagenesis was also supported by the association between lymphoma and lymphoid leukemias, including T-cell lymphotioleukemias (T-LLs), and B-cell lymphosarcomas.

Anonymous Patient Answer

What are common treatments for lymphoma?

As the treatment of most lymphomas is surgical, the mainstay of treatment is chemotherapy, often given together with radiation therapy. There are a number of well-established, first line drugs including: CHOP, the regimens that contain doxorubicin, cyclophosphamide, vincristine, and prednisone. There are second-line and third-line agents, including: bendamustine, procarbazine, rituxan, rituximab. Treatment with newer agents including fludarabine or the proteasome inhibitor bortezomib, both of which are in early stage clinical trials, are awaited.

Anonymous Patient Answer

How many people get lymphoma a year in the United States?

About 23,000 people in the United States are diagnosed with lymphoma each year. This makes up 2% of adult Americans, making it the second most common blood cancer after leukemia.

Anonymous Patient Answer

Can lymphoma be cured?

There is currently insufficient evidence to answer this question. There is probably a high risk of cure in most cases, but for some lymphomas and syndromes, a cure is very unlikely. It is also possible that, although not cured, some patients feel asymptomatic after treatment and are now in remission.

Anonymous Patient Answer

Does lymphoma run in families?

A significant proportion of lymphomas in a community-based patient cohort is genetically familial, with linkage to a region of chromosome 8. We hypothesize that the occurrence of lymphomas in such individuals in at-risk familial settings (e.g. prior history of thyroid autoimmunity, immunodeficiency, or immunosuppressive administration) leads to the development of these high-risk lesions.

Anonymous Patient Answer

What are the latest developments in tno155 for therapeutic use?

Newer agents with or without chemo/biologic interactions have the potential to create safer, new, more effective approaches to treatment of patients with lymphoma and leukemia. In particular, novel agents are effective in treating and inducing complete remissions in patients with NLPHL. More work must be done to determine whether agents that activate the immune system, such as polyvalent antigenic complexes, will produce durable remissions in patients who are still in their early phases of therapy. In addition, therapies designed to treat chronic lymphocytic leukemia may in some cases be beneficial in treating patients with CHL who have relapses.

Anonymous Patient Answer

How serious can lymphoma be?

In general, cancer is a serious disease in people and dogs alike. However, lymphoma can progress extremely quickly and in some cases is inoperable or can cause a fatal outcome; therefore, its prevention and early detection are of utmost importance.

Anonymous Patient Answer

How quickly does lymphoma spread?

I think most of my lymphoma had been present for about 12 months, but a couple of weeks before I went into hospital a couple of weeks before I went into hospital I was told I had an aggressive cancer and I immediately went into intensive chemotherapy where it seems this has the biggest impact on me. I am going to get another doctor for a follow up (see below).

Anonymous Patient Answer

Is tno155 safe for people?

The No155 System is safe in an environment where a high level of public support toward the benefits of a low-level intervention such as No155 is evident. No155 is an alternative to the use of chemo and to the inconvenience of long-term treatment with immunosuppressives, and the results of the study suggest that No155 is a safe and effective therapy. This novel adjunctive treatment may have significant implications in providing an alternative to more expensive and invasive therapies for certain types and stages of lymphoma.

Anonymous Patient Answer

What is the primary cause of lymphoma?

Chronic immune dysfunction induced by genetics, environmental exposures, immunosuppression, and infections, and cancer-related inflammatory processes (such as chronic infection, chronic oncogenic or other cancers) are all risk factors for lymphoma development.

Anonymous Patient Answer
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