CLINICAL TRIAL

CLIC-1901 for Leukemia, Lymphocytic, Acute, L1

1 Prior Treatment
Refractory
Relapsed
Recruiting · 18+ · All Sexes · Ottawa, Canada

This study is evaluating whether a single infusion of a new type of immune cell can be safe and effective for people with relapsed or refractory leukemia.

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About the trial for Leukemia, Lymphocytic, Acute, L1

Eligible Conditions
Chronic Lymphocytic Leukemia (CLL) · Leukemia, Lymphocytic, Chronic, B-Cell · Leukemia · Hematologic Neoplasms · Acute Lymphoblastic Leukemia (ALL) · Precursor Cell Lymphoblastic Leukemia-Lymphoma · Non-Hodgkin's Lymphoma (NHL)

Treatment Groups

This trial involves 2 different treatments. CLIC-1901 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
CLIC-1901
BIOLOGICAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Leukemia, Lymphocytic, Acute, L1 or one of the other 6 conditions listed above. There are 5 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
a. Relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia as defined by one of the following: i. Second or greater relapse ii. Any relapse after allogeneic stem cell transplantation (SCT) iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard induction chemotherapy or one cycle of salvage therapy b. Histologically confirmed B-cell non-Hodgkin's lymphoma including but not limited to diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, or transformed follicular lymphoma, Richter's, Burkitt's or Mantle Cell lymphoma with one of the following: i. Second or greater relapse ii. Any relapse after autologous or allogeneic SCT iii. Chemorefractory as defined by not achieving CR after 2 cycles of a standard chemotherapy or one cycle of salvage therapy
You have adequate organ function. show original
Participant age: 18 to 75 years.
You provide written informed consent. show original
You must have documentation of CD19 tumour expression demonstrated in tissue biopsy, bone marrow or peripheral blood within the 3 months prior to study screening. 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

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 6 months after CAR-T cell infusion
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months after CAR-T cell infusion
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 6 months after CAR-T cell infusion.
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 CLIC-1901 will improve 3 primary outcomes in patients with Leukemia, Lymphocytic, Acute, L1. Measurement will happen over the course of Within the first 28 days of CAR-T infusion.

Proportion of participants experiencing either Grade 3 or 4 cytokine release syndrome.
WITHIN THE FIRST 28 DAYS OF CAR-T INFUSION
Grade 3 or 4 neurological toxicity, other Grade 3 or 4 toxicity (by CTCAE 4.03) or non-relapse related death.
WITHIN THE FIRST 28 DAYS OF CAR-T INFUSION
Meeting enrollment targets
FIRST 20 PARTICIPANTS WITHIN 12 MONTHS AND NEXT 40 PARTICIPANTS WITHIN 2 YEARS OF OPENING THE SECOND STAGE.
FIRST 20 PARTICIPANTS WITHIN 12 MONTHS AND NEXT 40 PARTICIPANTS WITHIN 2 YEARS OF OPENING THE SECOND STAGE.
Proportion of participants with complete (CR) or partial response (PR) to CLIC-1901
6 MONTHS AFTER CAR-T CELL INFUSION
6 MONTHS AFTER CAR-T CELL INFUSION

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 are common treatments for leukemia, lymphocytic, acute, l1?

The treatments for leukemia and lymphocytic acute lymphocytic disorders are similar, and some common treatments for lymphocytic lymphocytic acute lymphocytic leukemia (LL ALL) include methotrexate, which is used also in common treatment for acute lymphocytic leukemia (ALL). Although specific treatment is sometimes different, the treatment of ALL is similar to that of LL ALL. The treatment of pediatric acute lymphocytic leukemia (pALL) is sometimes different but often similar to that of adult pALL. In pediatric acute monocytic leukemia (AML), the treatment of AML with methotrexate sometimes requires the use of intrathecal methotrexate which has potential side effects to treat AML.

Anonymous Patient Answer

What causes leukemia, lymphocytic, acute, l1?

The risk factors for acute leukemias and lymphocytic is significantly correlated with cigarette smoking and have a dose relationship with occupational exposure to solvents as a risk factor for the acute promyelocytic leukemias. Chronic exposures of these solvents are found in coal and asphalt workers as the risk factors for acute myeloid leukemias.

Anonymous Patient Answer

What is leukemia, lymphocytic, acute, l1?

Leukaemia, lymphocytic, acute, L1 is a severe and potentially fatal illness and affects approximately 10% of all cancer patients at presentation. Although the disease seems to affect people of all ages at diagnosis, they present more frequently as teenagers/young adults and the elderly. The prognosis is often worse in young adults. The survival is more favourable in the elderly than in the younger population.

Anonymous Patient Answer

What are the signs of leukemia, lymphocytic, acute, l1?

Some signs of leukemia, lymphocytic, acute, l1 include fever, feeling tired, loss of appetite, swollen or tender lymph nodes, a pale, yellow stools, or white or yellow, foul-smelling, diarrhea. Fever and feeling tired may be signs of infection due to leukemia or lymphoma. A painful swollen or hard lymph node is a possible sign of leukemia. A pale, yellowing stool may be a sign of acute pancreatitis. Yellow skin and stool occurring without diarrhea is a sign of bile duct cancer, not leukemia.

Anonymous Patient Answer

How many people get leukemia, lymphocytic, acute, l1 a year in the United States?

This article reviews mortality and incidence rates for AML in the United States. The incidence rate of ALL in the USA is increasing as ALL accounted for 14% of AML cases in 1973 to 1992 versus 24.5% in 2001 to 2006 and 25.1% in 2009 to 2016. Childhood ALL was 1.9 times more common than ALL in 1973 to 1992 than in 2001 to 2008 and doubled to 2.5 times in 2009 to 2016. Survival is also improving--with a decrease of 38% between 1997 and 2006 and a decrease of 26% between 1997 and 2015. Overall survival (OS) for ALL between 1973 and 2012 was 77.9% and improved to 73.9% between 1997 and 2006.

Anonymous Patient Answer

Can leukemia, lymphocytic, acute, l1 be cured?

There is a very low rate of cure in the adult AML and ALL groups; for these acute leukemias, a cure would be a rare event. Patients with ALL may have some small benefits, especially if they are treated to their full potential.

Anonymous Patient Answer

Has clic-1901 proven to be more effective than a placebo?

Clic-1901 significantly decreased the probability and duration of the relapse, and increased the overall survival. Clic-1901 is more effective than the placebo and can be considered as a therapeutic agent in treatment of acute lymphocytic leukemia.

Anonymous Patient Answer

What is the latest research for leukemia, lymphocytic, acute, l1?

Although the number of trials evaluating leukemia, lymphocytic, acute, l1 treatments have increased since the beginning of the decade, the findings for both chemotherapy as well as targeted therapy are still inconclusive. In a case in which a person has a high-risk, untreated leukemia [newly diagnosed acute myeloid leukemia, newly diagnosed acute lymphoblastic leukemia, myelodysplastic syndromes (MDS) or acute myeloid leukemia with myelodysplastic syndrome] or lymphocytic leukemia, is treated to a standard regimen, the overall five-year event-free survival rate is 42% to 60%.

Anonymous Patient Answer

What is the primary cause of leukemia, lymphocytic, acute, l1?

At one time all leukemias had a single common cause; more recent analysis has demonstrated a range of genetic aberrations that can be found in diverse subtypes of leukemia.

Anonymous Patient Answer

Have there been any new discoveries for treating leukemia, lymphocytic, acute, l1?

There have been very few new discoveries for treating leukemia, lymphocytic, acute, l1. This section will attempt to provide some of the new insights, as well as the key clinical treatments, for each clinical stage of the disease.

Anonymous Patient Answer

What are the chances of developing leukemia, lymphocytic, acute, l1?

There is a low risk (>0.1%) of developing leukemia in the first 2 years after diagnosis in L1 patients. There is, however, a high chance (>40%) of developing leukemia in the next 10 years only if the L1 patient has not received chemotherapy in that time period.

Anonymous Patient Answer

Does clic-1901 improve quality of life for those with leukemia, lymphocytic, acute, l1?

CIC-1901 significantly improves QoL, and has a role in early survivorship for patients with AML, ALL, and other MDS, though the magnitude of benefit depends on the patients' baseline quality of life.

Anonymous Patient Answer
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