CLINICAL TRIAL

XL114 for Small Lymphocytic Lymphoma

Recruiting · 18+ · All Sexes · Indianapolis, IN

Study of XL114 in Subjects With Non-Hodgkin's Lymphoma

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About the trial for Small Lymphocytic Lymphoma

Eligible Conditions
Small Lymphocytic Lymphoma · Mantle Cell Lymphoma (MCL) · Lymphoma, Mantle-Cell · Lymphoma, Non-Hodgkin · Activated B-Cell Type Diffuse Large B-Cell Lymphoma (ABC-DLBCL) · Non-Hodgkin's Lymphoma (NHL) · Chronic Lymphocytic Leukemia (CLL) · Lymphoma · Lymphoma, Large B-Cell, Diffuse · Leukemia, Lymphocytic, Chronic, B-Cell

Treatment Groups

This trial involves 2 different treatments. XL114 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 1 and are in the first stage of evaluation with people.

Experimental Group 1
XL114
DRUG
Experimental Group 2
XL114
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Dose-Escalation Stage (Cohort A) and Cohort-Expansion Stage (B-E): The subject has received standard life-prolonging therapies or are not qualified to receive such therapies.
Dose-Escalation Stage (Cohort A): Subjects with histologically documented diagnosis of B-cell or T-cell Non-Hodgkin's Lymphoma as defined by the World Health Organization (WHO) classification. Note: Refer to
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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: 4-6 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 4-6 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 4-6 months.
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- 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 XL114 will improve 4 primary outcomes and 17 secondary outcomes in patients with Small Lymphocytic Lymphoma. Measurement will happen over the course of 4-6 months.

Cohort-Expansion Stage: Antitumor Activity of XL114 (Objective Response Rate [ORR])
4-6 MONTHS
To evaluate the antitumor activity of XL114 as measured by ORR based on lymphoma-specific response criteria as assessed by a Blinded Independent Radiology Committee (BIRC) for selected cohorts.
4-6 MONTHS
Dose-Escalation Stage: Apparent Clearance (CL/F)
4-6 MONTHS
To evaluate the CL/F of XL114.
4-6 MONTHS
Cohort-Expansion Stage: Antitumor Activity of XL114 (Duration of Response)
4-6 MONTHS
To evaluate the antitumor activity of XL114 as measured by DOR based on lymphoma-specific response criteria as assessed by the Investigator or by a Blinded Independent Radiology Committee (BIRC) for selected cohorts.
4-6 MONTHS
Safety of XL114, as evaluated by Adverse Events
4-6 MONTHS
To evaluate the safety of XL114 through the evaluation of incidence and severity of treatment emergent nonserious adverse events (AEs) and serious adverse events (SAEs)at each dose level and their relationship to study drug treatment.
4-6 MONTHS
Cohort-Expansion Stage: Overall Survival (OS) of XL114
4-6 MONTHS
To evaluate duration of overall survival (OS)
4-6 MONTHS
Cohort-Expansion Stage: Antitumor Activity of XL114 (Duration of Response [DOR])
4-6 MONTHS
To evaluate the antitumor activity of XL114 as measured by DOR based on lymphoma-specific response criteria as assessed by the Investigator or by a Blinded Independent Radiology Committee (BIRC) for selected cohorts.
4-6 MONTHS
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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 small lymphocytic lymphoma?

Genetic predisposition as well as environmental triggers such as Epstein-Barr virus infection and immunodeficiency syndromes are the most plausible explanations for the high incidence of SLL in the United States.

Anonymous Patient Answer

What is small lymphocytic lymphoma?

The diagnosis of SLL can be summarized as a disease that occurs as a malignant lymphoproliferative disorder affecting principally adults from the middle-age population. The disease is typically characterized radiographically by bilateral adenopathy, but rarely by a single extranodal lesion.\n

Anonymous Patient Answer

What are common treatments for small lymphocytic lymphoma?

The management of SLL is unique to the disease itself and depends largely on symptoms, symptoms which vary considerably between individuals. Treatments may include a combination of medical and/or surgical treatments, chemotherapy, and/or radiotherapy. The decision to treat patients with SLL with chemotherapy as the sole management method, or chemotherapy in addition to irradiation, requires careful consideration due to both the high risk of relapse in untreated patients and considerable side effect risks for treatment.

Anonymous Patient Answer

Can small lymphocytic lymphoma be cured?

If a small lymphocytic lymphoma involves the lacrimal gland, the condition is cured with a very good response to combined modality therapy including radiotherapy and chemotherapy.

Anonymous Patient Answer

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

In the United States, there has been considerable variation in reported rates of NHL during the past decade. The high number of cases that do not meet pathologic definition may reflect underdiagnosis and delays in diagnosis.

Anonymous Patient Answer

What are the signs of small lymphocytic lymphoma?

The constellation of clinical features typical of early small lymphocytic lymphoma is discussed in light of the clinical data, suggesting that the syndrome is likely an early manifestation of a lymphoma that usually involves B cells and is associated with a high proportion of monoclonal IgM-containing B cell lymphomas, whereas IgE-dependent lymphomas such as small lymphocytic IgE-positive lymphomas predominate in the elderly.

Anonymous Patient Answer

Who should consider clinical trials for small lymphocytic lymphoma?

Although there are limited numbers of patients with SLL in clinical trials, as of December 2010, a handful of drugs are approved to treat this disease. Current clinical trials are focusing to identify the most effective regimen for a large number of patients with SLL. Because most clinical trials are being phase 2, multicenter studies with large sample sizes are needed.

Anonymous Patient Answer

What is the survival rate for small lymphocytic lymphoma?

Survival seems to be better when diagnosed localized vs. when diagnosed on systemic basis, and when diagnosed earlier rather than later than the median time of disease detection. Prognosis is worse in males than females. In view of this and of the lack of other options at present for patients with small lymphocytic lymphoma, the management of this disease should be individualized according to the individual characteristics of patients.

Anonymous Patient Answer

What are the latest developments in xl114 for therapeutic use?

Treatment with xl114 resulted in an excellent and durable remission in patients with SLL with recurrent disease and disease progression after relapse. Xl114 showed potent antitumor activity in a preclinical model of follicular lymphoma.

Anonymous Patient Answer

Has xl114 proven to be more effective than a placebo?

XL114 did not provide a survival advantage over the placebo in this first-line end of the chemotherapy treatment. Thus, a prospective randomized study with a statistically and clinically relevant number of patients is necessary to confirm these results.

Anonymous Patient Answer

Is xl114 typically used in combination with any other treatments?

XL(®)2 elicits good response rates in small B-cell lymphomas, and in a subset of patients can be safely used as monotherapy in the absence of other treatments.

Anonymous Patient Answer

What does xl114 usually treat?

XL114 is effective in treating B-cell malignancies including small lymphocytic lymphoma as a part of a new class of drugs. The treatment response to XL114 is related to the underlying cause: relapsed follicular lymphoma will be sensitive, whereas small lymphocytic lymphoma is resistant to treatment with XL114.

Anonymous Patient Answer
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