Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Vitebsk Regional Clinical Cancer Centre · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
This is a Phase I/II interventional, open-label treatment study designed to evaluate the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
* Documented CD19+ CLL or SLL
* Patients must have failed at least 1 prior regimen
* Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:
* Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
* ECOG Perf…
Inclusion Criteria:
* Documented CD19+ CLL or SLL
* Patients must have failed at least 1 prior regimen
* Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and:
* Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
* ECOG Performance status 0 or 1
* 18 years of age and older
* Adequate organ system function including:
Creatinine \< 1.6 mg/dl ALT/AST \< 3x upper limit of normal Total Bilirubin \<2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
* Have no active GVHD and require no immunosuppression
* Are more than 6 months from transplant
* No contraindications for leukapheresis
* Left Ventricular Ejection fraction \>50%
* Gives informed consent
Exclusion Criteria:
* CLL patients with known or suspected transformed disease (i.e. Richter's transformation).
* Pregnant or lactating women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids or chronic use of immunosuppressant medications.
* Any uncontrolled active medical disorder
* HIV infection.
* Patients with active CNS involvement with malignancy.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* Subjects with clinically apparent arrhythmia or arrhythmias who are not stable
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.