Copiktra

Chronic Lymphocytic Leukemia, Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell + 1 more

Treatment

2 Active Studies for Copiktra

What is Copiktra

Duvelisib

The Generic name of this drug

Treatment Summary

Duvelisib, also known as IPI-145 and INK-1197, is a medication designed to reduce the activity of two forms of an enzyme called phosphoinositide-3 kinases. This drug was developed by Verastem, Inc and was approved by the FDA in 2018. It is commonly used to inhibit the activity of both adaptive and innate immune cells.

Copiktra

is the brand name

image of different drug pills on a surface

Copiktra Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Copiktra

Duvelisib

2018

6

Effectiveness

How Copiktra Affects Patients

Duvelisib is a medication used to treat certain types of leukemia and lymphoma. In laboratory studies, it was found to be effective at reducing the growth of cancer cells even when other treatments had failed. In clinical trials, it was found to be twice as effective as the drug ofatumumab in treating chronic lymphocytic leukemia or small lymphocytic leukemia, with a median progression-free survival of 16.4 months and an overall response rate of 78%. For patients with follicular lymphoma, the overall response rate was 42%, with 43% of them maintaining the response for at least 6 months and 17% for at

How Copiktra works in the body

Duvelisib works by blocking the activity of two forms of the protein phosphoinositide3-kinase (PI3K). PI3K plays an important role in the body's immune system and blocking it suppresses the immune response. Duvelisib also blocks the signaling from BCR (B cell receptor), which is critical for the growth and survival of lymphoma cells. It also blocks paracrine and autocrine pro-survival signals, like adhesion molecules, chemokines and soluble factors. By blocking these proteins, duvelisib encourages the recognition and elimination of tumor cells.

When to interrupt dosage

The proposed measure of Copiktra is contingent upon the recognized condition, including Lymphoma, Follicular, Refractory anemias and refractory, relapsed small lymphocytic lymphoma. The amount of dosage is subject to the technique of delivery (e.g. Capsule - Oral or Capsule) specified in the following table.

Condition

Dosage

Administration

Leukemia, Lymphocytic, Chronic, B-Cell

15.0 mg, 25.0 mg,

, Capsule, Oral, Capsule - Oral

Chronic Lymphocytic Leukemia

15.0 mg, 25.0 mg,

, Capsule, Oral, Capsule - Oral

Lymphoma

15.0 mg, 25.0 mg,

, Capsule, Oral, Capsule - Oral

Therapeutic procedure

15.0 mg, 25.0 mg,

, Capsule, Oral, Capsule - Oral

Warnings

There are 20 known major drug interactions with Copiktra.

Common Copiktra Drug Interactions

Drug Name

Risk Level

Description

9-aminocamptothecin

Moderate

The metabolism of 9-aminocamptothecin can be decreased when combined with Duvelisib.

Abemaciclib

Moderate

The metabolism of Abemaciclib can be decreased when combined with Duvelisib.

Acalabrutinib

Moderate

The metabolism of Acalabrutinib can be decreased when combined with Duvelisib.

Acenocoumarol

Moderate

The metabolism of Acenocoumarol can be decreased when combined with Duvelisib.

Alectinib

Moderate

The metabolism of Alectinib can be decreased when combined with Duvelisib.

Copiktra Toxicity & Overdose Risk

There is no evidence to suggest that duvelisib is carcinogenic. In fertility studies, some histological abnormalities were observed in rats, including thinning of the seminiferous epithelium in the testes, decreased testes weight, soft testes, small epididymis, low sperm count/absence of sperm, reduced ovary weight, and thinning of the uterus.

Copiktra Novel Uses: Which Conditions Have a Clinical Trial Featuring Copiktra?

167 active trials are in progress to investigate the potential of Copiktra for Therapeutic Procedures, prior therapies, as well as for the treatment of Follicular Lymphoma.

Condition

Clinical Trials

Trial Phases

Therapeutic procedure

0 Actively Recruiting

Lymphoma

0 Actively Recruiting

Leukemia, Lymphocytic, Chronic, B-Cell

2 Actively Recruiting

Phase 1

Chronic Lymphocytic Leukemia

0 Actively Recruiting

Copiktra Reviews: What are patients saying about Copiktra?

1

Patient Review

9/13/2019

Copiktra for Chronic Lymphocytic Leukemia

My husband died after just two weeks of taking this medication. He and I were the only ones who saw the immediate adverse effects; our children didn't even notice anything until it was too late.

1

Patient Review

6/9/2019

Copiktra for Chronic Lymphocytic Leukemia

My husband passed away after using this drug for two weeks.

Patient Q&A Section about copiktra

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

How is Duvelisib administered?

"The recommended dose of duvelisib is 25 mg taken orally twice daily in 28-day treatment cycles."

Answered by AI

Who manufactures Copiktra?

"We are going to evaluate the long-term safety of Copiktra by requiring the drug manufacturer, Secura Bio, to submit the final 5-year survival results from the clinical trial called DUO trial. This trial is a phase 3, randomized, open-label trial."

Answered by AI

What is Copiktra used for?

"This medication is used to treat certain types of cancer, such as chronic lymphocytic leukemia and small lymphocytic lymphoma. Duvelisib belongs to a class of drugs known as kinase inhibitors, which work by slowing or stopping the growth of cancer cells."

Answered by AI

Clinical Trials for Copiktra

Image of Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute in Cleveland, United States.

BAFF CAR-T Cells for Chronic Lymphocytic Leukemia

18+
All Sexes
Cleveland, OH

CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function. BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.

Phase 1
Recruiting

Case Comprehensive Cancer Center, Cleveland Clinic Foundation Taussig Cancer Institute

Paolo Caimi, MD

Image of Houston Methodist Hospital in Houston, United States.

CD19.CAR-aNKT Cells for Lymphoma and Leukemia

3 - 75
All Sexes
Houston, TX

This study is for patients who have lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to volunteer for a gene transfer research study using special immune cells. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting disease, antibodies and immune cells. Antibodies are types of proteins that protect the body from bacteria and other diseases. Immune cells, also called lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and lymphocytes have been used to treat patients with cancer. They have shown promise, but have not been strong enough to cure most patients. The antibody used in this study is called anti-CD19. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD19. CD19 antibodies have been used to treat people with lymphoma and leukemia. For this study, the anti-CD19 antibody has been changed so that instead of floating free in the blood it is now joined to the NKT cells, a special type of lymphocytes that can kill tumor cells but not very effectively on their own. When an antibody is joined to a T cell in this way it is called a chimeric receptor. Investigators have also found that NKT cells work better if proteins are added that stimulate lymphocytes, such as one called CD28. Adding the CD28 makes the cells last for a longer time in the body but maybe not long enough for them to be able to kill the lymphoma cells. It is believed that by adding an extra stimulating protein, called IL-15, the cells will have an even better chance of killing the lymphoma cells. In this study the investigators are going to see if this is true by putting the anti-CD19 chimeric receptor with CD28 and the IL-15 into NKT cells grown from a healthy individual. These cells are called ANCHOR cells. These cells will be infused into patients that have lymphomas or leukemias that have CD19 on their surface. The ANCHOR cells are investigational products not approved by the Food and Drug Administration. The purpose of this study is to find the biggest dose of ANCHOR cells that is safe, to see how long the ANCHOR cells last, to learn what their side effects are and to see whether this therapy might help people with lymphoma or leukemia.

Phase 1
Waitlist Available

Houston Methodist Hospital (+1 Sites)

Carlos Ramos, MD