CPO107 for Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University - Saul A Rosenberg Prof of Lymphoma Stanford Cancer Institute, Stanford, CA
Lymphoma+2 More
CPO107 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Dose Escalation and Expansion Study of CPO107 for Patients With Advanced CD20-positive Non-Hodgkins Lymphoma

See full description

Eligible Conditions

  • Lymphoma
  • CD20 Positive Non Hodgkin Lymphoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether CPO107 will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of through study completion, an average of 1 year.

Year 1
Efficacy assessment
Expression of anti-drug antibody (ADA)
Pharmacokinetic (PK)
Safety assessment-Incidence of treatment-emergent AEs (TEAEs)
To determine the recommended single-agent CPO107 RP2D

Trial Safety

Trial Design

3 Treatment Groups

Part B
1 of 3
PartA- Arm B
1 of 3
PartA- Arm A
1 of 3
Experimental Treatment

This trial requires 75 total participants across 3 different treatment groups

This trial involves 3 different treatments. CPO107 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.

Part B
Drug
Part B with either: second or greater relapse OR refractory patients, as defined by not achieving a CR after 2 cycles of a standard first line chemoimmunotherapy regimen or not achieving a CR following 1 cycle of a second line chemotherapy regimen.
PartA- Arm B
Drug
Arm B will explore a 3 weekly schedule in which a single dose is administered every 3 weeks (1 cycle=21 days=1 treatment). The starting dose for Arm B will be the dose level below the Arm A level that provides an equivalent dose over a 3-week period.
PartA- Arm A
Drug
Arm A 1-6 subjects will be enrolled at dose levels of CPO107 at (1, 3, 6, 12, 20 mg/kg). Each subject group will receive multiple cycles of a weekly dose of CPO-107 (1 cycle=21 days=3 treatments).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 1 year for reporting.

Closest Location

Stanford University - Saul A Rosenberg Prof of Lymphoma Stanford Cancer Institute - Stanford, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 2 prior treatments for Lymphoma or one of the other 2 conditions listed above. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of CD20 positive NHL. CD20 assay to have been performed within 6 months prior to protocol entry. Eligible NHL subtypes include Diffuse Large B-Cell Lymphoma (DLBCL, not otherwise specified, NOS), Follicular Lymphoma, Chronic lymphocytic leukemia/small lymphocytic lymphoma, B cell prolymphocytic leukemia and Mantle cell lymphoma.
You are eligible for this study. show original
You have two or more prior lines of conventional systemic therapy for advanced disease. show original
A clinical indication for treatment must be present for patients with Follicular Lymphoma and Chronic/Small/Prolymphocytic/Mantle B-cell non-Hodgkin lymphoma.
Having at least one measurable target lesion present and documented by RECIST 1.1.
You have adequate organ function. show original
Complete resolution of all prior toxicities from prior anticancer therapy, defined as having resolved to baseline or to common terminology criteria for adverse events (CTCAE) grade≤1, with the exception of alopecia, or to the levels dictated in the inclusion/

Patient Q&A Section

What causes lymphoma?

"Lymphoid Leukemia and Lymphoma may be caused by the same genetic mechanisms. This finding suggests a common cause for the development of all forms of lymphoma. These data suggest a possible contribution of some types of infectious agents (especially retroviral infections) to development of lymphoma." - Anonymous Online Contributor

Unverified Answer

Can lymphoma be cured?

"There are several factors that are significant in determining the prognosis of lymphoma patients. The most important factors are the type of cancer, staging of cancer, the staging of lymphoma, the level of performance status, gender, and age." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma?

"Most often, lymphomas are treated with chemotherapy with or without steroids and/or targeted agents. However, the course of some lymphomas may be self-limiting and there is little evidence to support the use of radiation or immunotherapy.\n" - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma?

"Those with signs of lymphoma tend to present with a single site of disease, are more likely to be male, and have disseminated disease at presentation. They are also more likely to have other medical diagnoses (other than lymphoma), and are less likely to receive appropriate therapy for lymphoma. As many as 80% of all newly diagnosed lymphomas involve the lungs (pleural) or the lymph nodes (mediastinal)." - Anonymous Online Contributor

Unverified Answer

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

"There are an average of 2.1 new cases of lymphoma for every 100,000 people per year. In 2009, around 26,800 people were diagnosed with lymphoma. Lymphoma is the most common cancer in men and women diagnosed in 2009. People of Caucasian ethnicity and older people were more likely to be diagnosed with lymphoma in 2008 than in 1998." - Anonymous Online Contributor

Unverified Answer

What is lymphoma?

"Lymphoma is a group of blood cancers that involve the white cells that are part of the immune system. It is diagnosed either by imaging tests or biopsy. Most cases are curable and can be treated, but a number of lymphomas are not. The most common types are non-Hodgkin's lymphoma, large non-Hodgkin's lymphoma, MALT lymphoma and follicular lymphoma." - Anonymous Online Contributor

Unverified Answer

What is the latest research for lymphoma?

"Although recent progress has been made in understanding lymphoma mechanisms, there is still a lack of knowledge about key cell pathways, and this knowledge is likely to be essential to developing the next generation of lymphoma treatments. The current treatment algorithms and chemotherapies used in lymphoma-related cases may have limitations and have adverse impacts on patients’ quality of life." - Anonymous Online Contributor

Unverified Answer

Is cpo107 safe for people?

"Cpo-107, a first-in-class small molecule inhibitor of the human Cpo-receptor, is safe and well tolerated in healthy volunteers and patients with relapsed follicular lymphoma with good antitumour activity." - Anonymous Online Contributor

Unverified Answer

Does cpo107 improve quality of life for those with lymphoma?

"CPO107 can improve QoL in patients with NHL. The use of CPO107 is safe, tolerable, and has potential clinical and cost savings, suggesting that more patients could be treated effectively." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for lymphoma?

"The risk of being undertreated by trial participation may outweigh any potential benefit. Patients with newly diagnosed lymphoma should be informed of the risks of being undertreated, as well as trial options, with the goal of shared decision-making, in order to optimise patient outcomes." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of cpo107?

"Symptoms of cpo107 can include constipation, nausea, anorexia, vomiting, diarrhea, headache, miosis. There is also a high risk that some of the patients who reported these side effects actually did not have this side effect. Therefore, some of the patients who complain about side effects may not actually have the side effect of cpo107 in question." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma?

"In recent years, the world is changing dramatically from a rural to an urbanized society. This trend is already present in Finland as the population moves closer to the city center. Over the last decade there has been rapid population growth, and in Finland, there is a corresponding rise in tuberculosis cases. This suggests a new factor as the most likely cause of lymphoma: TB. This is the first time a link has been established between tuberculosis and lymphoma, and it is certainly not a rare event. But there is no conclusive evidence supporting a relationship between lymphoma and tuberculosis." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Lymphoma by sharing your contact details with the study coordinator.