Crizotinib for Lymphoma

Phase-Based Estimates
2
Effectiveness
3
Safety
Queen Mary Hospital; Dept. of Clinical Oncology, Hong Kong, Hong Kong
Lymphoma+1 More
Crizotinib - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
Lymphoma

Study Summary

This study is evaluating whether a drug called alectinib can be used to treat people with lung cancer that has a gene mutation.

See full description

Eligible Conditions

  • Lymphoma
  • Cancer
  • Neoplasms

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether Crizotinib will improve 2 primary outcomes and 1 secondary outcome in patients with Lymphoma. Measurement will happen over the course of From first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment).

Week 4
Number and Causes of Death Occurring on Study
Number of Patients With Clinically Significant Laboratory Values as per Protocol for Selected Safety Laboratory Parameters
Number of Patients with Serious Adverse Events (SAEs), Non-serious Adverse Events (non-SAEs) and Adverse Events of Special Interest

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

No Control Group
Alectinib

This trial requires 200 total participants across 2 different treatment groups

This trial involves 2 different treatments. Crizotinib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 3 and have had some early promising results.

Alectinib
Drug
Participants will receive alectinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Crizotinib
Drug
Participants will receive crizotinib at the same dose and schedule and according to the same administration guidelines as they received at the time of discontinuation from the parent trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alectinib
FDA approved
Crizotinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from first dose of study treatment and until the safety follow-up visit (4 weeks after the last dose of study treatment) for reporting.

Closest Location

Massachusetts General Hospital Cancer Center - Boston, MA

Eligibility Criteria

This trial is for patients born any sex of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Participants enrolled in a Roche-sponsored alectinib trial who are experiencing a clinical benefit from alectinib or crizotinib treatment at the time of discontinuation from the parent trial and for whom a switch to commercial supply is not feasible
Collected study termination data, including efficacy and safety data, as required by the parent study on the electronic Case Report Form (eCRF)
For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug
For men: agreement to remain abstinent or use a contraceptive method that results in a failure rate of < 1% per year during the treatment period and for at least 3 months after the last dose of study drug.

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 causes lymphoma?

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Most lymphomas are now classified into the same subgroups, as recognized by their chromosomal translocations and associated proteins. Most frequently, the lymphocyte lineage is involved. This article provides a practical overview of the lymphoma subgroups, with more detailed articles on the specific lymphoma types.

Unverified Answer

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

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The lymphoma data for the most recent year available from the SEER database (2001 to 2003) show 3,100 new lymphoma diagnoses in the United States. This includes 1,600 new reports of non-B cell lymphoma, while an additional 990 reports are diagnosed with B cell lymphoma. The most common age-groups for lymphoma (defined by number of reported cases per 100,000 population) are children aged 0-14 years (7,400), older individuals (over 70,800), and adults (6,450).

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What are the signs of lymphoma?

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This article contains images of lymphomas. The images are all included with permission of the owners. The authors declare they have no interests in commercialising the material.

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What is lymphoma?

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Lymphoma and lymphocytopenia are both diseases of the lymphatic system in which the immune system is compromised. Lymphoma is a cancer that forms lymphoid tissue of bone marrow or lymph nodes, including lymph glands, and lymph nodes. Symptoms of lymphoma can include unexplained fever, rapid and painful swelling of the lymph glands and lymph nodes, and/or unexplained weight loss. Diagnosis and treatment of lymphoma depends on the subtype of lymphoma, how it spreads in the body, and whether it is curable with chemotherapy, radiation, or surgery (lymphoma is often curable when it can be pinpointed to its site of origin).

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What are common treatments for lymphoma?

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Although the initial management of the first-line lymphomas is often radical, and, where feasible, chemotherapy. The treatment regimens are highly dependent on the stage of disease; however, some of the more common treatment regimens used in lymphoma include platinum, cyclophosphamide, and various forms of radiotherapy. The overall five-year survival rates for lymphoma patients are high. Because most patients who are treated for lymphoma survive for at least five years, long-term survival is often a realistic goal.\n

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Can lymphoma be cured?

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Lymphoma is a potentially curable cancer but has yet to be fully curable. There are numerous parameters that affect the outcome of treatment. These include age, stage, location, aggressiveness of disease and response to previous chemotherapy, and of course the type and grade of cancer. In addition, the patient's immune capability is an important factor. All patients should be informed of the long-term consequences of treatment even if they are in remission. There's no point in feeling as though there's something out there that can pull us back to the mortal coil. While we can't cure, we can make it tolerable and even desirable.

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What is the average age someone gets lymphoma?

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The average age a person develops lymphoma is 49 years (95% confidence interval, 45-55 years). Most patients develop the disease because the cells do not live longer, but due to chemotherapy or radiation. If there are family members who also have lymphoma, their average age is 45 years (95% confidence interval, 42-48 years). Gender does not impact what happens to lymphoma patients.

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How serious can lymphoma be?

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Overall, a canine lymphoma that was found to have reached stage V by complete laboratory examination was treated with an appropriate chemotherapy regimen in 8 days time and there were no signs of relapse. In this sense, the overall prognosis for that particular dog appears pretty good. Canine lymphoma remains a challenging disease to treat, since it evolves so quickly. When diagnosed early enough in the disease spectrum, it can still be treated successfully and with a very good prognosis, provided that the disease can be diagnosed and treated in time and that proper care is performed by a veterinarian.

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What are the chances of developing lymphoma?

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The chances of developing lymphoma depend on the type of cancer you have, the length of time it has existed, and when your blood tests were taken for the first time. The average probability of getting lymphoma has increased steadily over the past 50 years. This is a cause for concern as the trend in statistics suggests that lymphoma incidence may also be increasing. This means that it is better to be cautious about the risks of contracting lymphoma; even though lymphoma itself has not changed in incidence. However a complete blood count should still be taken every three months without delay. In addition a routine scan of the liver to check for liver disease should be undertaken every two years and there is no doubt that regular screening may help early detection.

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What is the primary cause of lymphoma?

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Lymphoma is a complex disease. Symptoms can be non-specific and it requires advanced radiological work-up to make a differential diagnosis. If the treatment is to be appropriate, information on prognosis should be discussed on which tumours can be expected to remit and persist. When deciding, it is important to consider the course of events and the likelihood of being cured of your cancer before and after chemotherapy, especially in those in whom initial remission is poor.

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Have there been any new discoveries for treating lymphoma?

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Recently there have been no new breakthroughs in treating lymphoma. Findings from a recent study obtained in combination chemotherapy for diffuse large B-cell lymphoma are still not promising. However, new results in other categories of lymphoma are not very impressive and will likely remain disappointing until the development of new concepts, target-based therapy and/or novel drugs. It is also necessary to develop more accurate and sensitive markers to monitor treatment response. The first and only indication for new therapeutic approaches seems to be a more complete understanding of the biology of lymphomas, and the development of approaches that can interfere more specifically with the proliferation and survival of lymphoma cells.

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Who should consider clinical trials for lymphoma?

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Clinical trials were considered too frequently from various perspectives, especially those of the patients. Therefore, patients should not refuse consent before considering clinical trial participation.

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