CLINICAL TRIAL

Tenalisib for Lymphoma

Waitlist Available · 18+ · All Sexes · Houston, TX

Study to Evaluate the Efficacy and Safety of Tenalisib, Given With CHOP Therapy for Front Line Treatment in Patients With PTCL

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About the trial for Lymphoma

Eligible Conditions
Lymphoma · Peripheral T Cell Lymphoma (PTCL) · Lymphoma, T-Cell, Peripheral · Lymphoma, T-Cell

Treatment Groups

This trial involves 2 different treatments. Tenalisib 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 2 and have already been tested with other people.

Experimental Group 1
Tenalisib
DRUG
Experimental Group 2
Tenalisib
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tenalisib
2019
Completed Phase 2
~60

Side Effect Profile for Tenalisib

Tenalisib
Show all side effects
29%
Anemia
24%
Neutropenia
19%
Alanine aminotransferase increased
19%
Aspartate aminotransferase increased
10%
Diarrhea
10%
Thrombocytopenia
10%
Pneumonia
10%
Blood alkaline phosphatase increased
Anemia
29%
Neutropenia
24%
Alanine aminotransferase increased
19%
Aspartate aminotransferase increased
19%
Diarrhea
10%
Thrombocytopenia
10%
Pneumonia
10%
Blood alkaline phosphatase increased
10%
This histogram enumerates side effects from a completed 2020 Phase 2 trial (NCT04204057) in the Tenalisib ARM group. Side effects include: Anemia with 29%, Neutropenia with 24%, Alanine aminotransferase increased with 19%, Aspartate aminotransferase increased with 19%, Diarrhea with 10%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Provision of full informed consent prior to any study-specific procedures.
ALK-positive anaplastic T-cell lymphoma; CD30+ PTCL (who are eligible for BV and CHOP combination); extra-nodal NK/T-cell lymphoma, nasal type; HTLV1- associated lymphoma; primary cutaneous anaplastic T-cell lymphoma, T-cell lymphoma with only skin involvement
Must have ECOG performance status ≤ 2
You have measurable disease defined as at least one bi-dimensional measurable lesion assessed radiologically with a minimum measurement of > 1.5 cm in the longest diameter. show original
You are fit to receive full-dose CHOP Therapy. show original
Adequate bone marrow, liver and renal functions
You have PTCL and have not received prior systemic therapy for lymphoma. show original
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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: 3 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 3 years.
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 Tenalisib will improve 1 primary outcome and 4 secondary outcomes in patients with Lymphoma. Measurement will happen over the course of 9 months.

Overall Response Rate (ORR) at the end of T-CHOP treatment.
9 MONTHS
ORR is defined as sum of CR and PR rates, as assessed by the Investigator according to the Lugano Classification
9 MONTHS
Complete Response (CR) rate at the end of T-CHOP treatment.
9 MONTHS
CR rate is defined as the percentage of patients showing complete response as assessed by the Investigator according to the Lugano Classification.
9 MONTHS
Progression-Free Survival (PFS)
3 YEARS
PFS is defined as the duration of time from start of treatment to time of documentation of progression or death from any cause
3 YEARS
Duration of Response (DoR)
3 YEARS
The duration of response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
3 YEARS
Overall Survival (OS)
3 YEARS
OS is defined as the duration of time from start of treatment to death from any cause.
3 YEARS

Patient Q & A Section

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

How many people get lymphoma, t-cell a year in the United States?

About 0.4 million US Americans are diagnosed with lymphoma, 1.1 million with T-cell lymphoma, and 564,000 with non-Hodgkin lymphoma a year. This is a high rate of lymphoma in the United States and a major cause of cancer deaths. T-cell lymphoma causes about half of non-Hodgkin lymphoma and is the highest-grade form. The rate of non-Hodgkin lymphoma is rising and causes a 3-fold increase between 1972 and 1997. Findings from a recent study underscore the importance of early detection of lymphoma, particularly lymphoma of all types, which has been shown to have the best prognosis.

Anonymous Patient Answer

What are the signs of lymphoma, t-cell?

There are many signs and symptoms of lymphoma/t-cell. Symptoms are common and may include feeling unwell, weight loss, loss of appetite and night sweats. In more severe cases, symptoms may include a fast heart rate, low blood pressure, and chest pain. Severe lymphoma/t-cell may cause a swollen neck, facial rash, or other symptoms. The main symptom is the one that gives the most clues to a diagnosis of lymphoma/t-cell. There is no easy way of telling which symptom points to lymphoma/t-cell which is more likely to be the cause.

Anonymous Patient Answer

What causes lymphoma, t-cell?

The risk of developing lymphoma is higher for a family member who has died from lymphoma, which suggests that genetic factors are an important risk factor for developing lymphoma and may help to identify people at risk. There is some evidence that exposure to certain drugs, particularly those of the arylcyclohexene group, increases the risk of developing lymphoma. While this group of drugs is not used much in Western countries, they are still used in many Asian countries; consequently this reinforces the hypothesis that lymphoma is partly heritable. The role of the environment in lymphoma development needs to be further investigated.

Anonymous Patient Answer

What is lymphoma, t-cell?

Lymphoma, t-cell, is a cancer of the immune system in which white blood cells grow into cancer cells. These cancer cells may be present in the circulation. This form of cancer is a group of cancers involving a clone of T-cells. These specific T-cells are activated and grow unchecked resulting in the characteristic features of lymphoma, t-cell. Cancer, lymphoma, t-cell.

Anonymous Patient Answer

What are common treatments for lymphoma, t-cell?

Treatments include chemotherapy, radiotherapy, and/or steroids. Chemotherapy, such as etoposide and taxol, is often used alone or in combination with steroids or radiotherapy. For t-cell lymphoma, chemotherapy may also be the preferred first-line treatment.

Anonymous Patient Answer

Can lymphoma, t-cell be cured?

Lymphoma and mycosis are difficult cancers to cure. These cancers are unlikely to result in cure if aggressive therapy is not combined with chemosensitisation or other agents.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphoma, t-cell?

The finding of a novel RARalpha-mediated BCL-2-dependent anti-apoptotic mechanism of action raises the potential application of RARalpha to the development of selective targeted therapies and chemoprevention of B cell lymphoma.

Anonymous Patient Answer

Does lymphoma, t-cell run in families?

Since the T2 family is predominantly found in patients with T-cell lymphoma (T-cell leukemia/lymphoma) and a history of T-cell lymphoma in family members, it is recommended that lymphoma patients on a high-risk chemoimmunotherapy regimen be offered testing of the B and T loci as well as the high-risk T-cell receptor gene complement.

Anonymous Patient Answer

What is the latest research for lymphoma, t-cell?

The latest research for t-cell includes: 1) Immunotherapy: As the cure for lymphoma seems [slow to happen] and the number of treatments a patient needs for their lymphoma is usually increasing (two or three more treatments than a few years ago), research is aiming at developing therapies that would allow a patient to spend less time in the clinic, less time in the hospital. 2) Genetic therapy: There is more attention to t-cells’ needs for a long time. It is really necessary for patients with T-cell non-Hodgkin’s lymphoma to be treated by a multidisciplinary team to get the optimal use of the best treatment,”said Jonathan T.

Anonymous Patient Answer

Have there been other clinical trials involving tenalisib?

Tenalisib, which has shown promising results in the treatment of cutaneous B-cell lymphoma, was explored as a treatment option for patients with DLBCL and was well tolerated. Recent findings will guide the decision of the patient and will help to define the precise role of this drug for this disease if further experimentation and prospective testing is carried out.

Anonymous Patient Answer

Does tenalisib improve quality of life for those with lymphoma, t-cell?

Tenalisib significantly improved physical QOL versus placebo, as assessed at the end of the treatment period in patients with relapsed or refractory CLL and PLL.

Anonymous Patient Answer

Is tenalisib typically used in combination with any other treatments?

Patients treated with tenalisib had a high disease-free survival rate, regardless of the presence of visceral pain or nausea. The majority of patients experienced grade ≥ 2 sensory neuronopathy. Tenalisib appears to be generally well tolerated in combination with other treatments.

Anonymous Patient Answer
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