Overview

Autologous ROR1R-CAR-T Cells for Chronic Lymphocytic Leukemia (CLL)

Status:
Withdrawn
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
Gene transfer is a process in which the DNA (genetic material) of certain cells is changed. In this study, gene transfer will be performed on a type of white blood cell (called T cells) to recognize leukemia cells in the same person the T cells were collected from. The goal of this clinical research study is to learn if it is safe to give these genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if these cells can help to attack CLL/SLL cells.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborator:
CLL Global Research Foundation Alliance
Treatments:
Bendamustine Hydrochloride
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Rituximab
Vidarabine
Criteria
Inclusion Criteria:

1. Patients with B cell CLL/SLL, age 2008 IWCLL/NCI-WG criteria to initiate treatment.

2. Patients who have failed at least one line of a standard treatment, including
bendamustine, fludarabine, ibrutinib, or alemtuzumab and require treatment within 2
years of completion of last treatment regimen or untreated patients with del17p by
FISH (high-risk) who do not have an allogeneic stem cell transplant option.

3. At least 21 days from last cytotoxic chemotherapy.

4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) <2.

5. Adequate hepatic function, defined as substance glutamate pyruvate transaminase (SGPT)
<3 x upper limit of normal (ULN); serum bilirubin and alkaline phosphatase <2 x ULN,
or considered not clinically significant by the study doctor or designee.

6. Adequate renal function, defined as serum creatinine <2 x ULN.

7. Able to provide written informed consent, and agree to practicing 2 forms of birth
control during the study.

8. Patients must have adequate cardiac function as indicated by New York Heart
Association (NYHA) classification I or II AND left ventricular ejection fraction of
>40% and adequate pulmonary function as indicated by room air oxygen saturation of
>94%.

Exclusion Criteria:

1. Surface ROR1 expression by <5% of CLL cells.

2. Positive beta-HCG in female of child-bearing potential defined as not post-menopausal
for 12 months or no previous surgical sterilization or lactating females.

3. Patients with known systemic allergy to bovine or murine products.

4. Known positive serology for human immunodeficiency virus (HIV) or human anti-mouse
antibody (HAMA).

5. Active, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic
thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy.

6. Presence of >/= Grade 3 non-hematologic toxicity common terminology criteria (CTC)
version 4 from the previous treatment.

7. Concurrent use of investigational therapeutic agent.

8. Prior allogeneic hematopoietic stem-cell transplantation if evidence of donor
chimerism persists. Patients with exclusively autologous hematopoiesis are eligible.

9. Refusal to participate in the long-term follow-up protocol (2006-0676).