Status:
WITHDRAWN
Autologous ROR1R-CAR-T Cells for Chronic Lymphocytic Leukemia (CLL)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
CLL Global Research Foundation Alliance
Conditions:
Leukemia
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
Brief 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 l...
Detailed Description
Standard Blood Draw or Leukapheresis (to collect T cells): If you are found to be eligible to take part in this study, you will have T cells collected from your blood. This will be done by a standard...
Eligibility Criteria
Inclusion
- Patients with B cell CLL/SLL, age \</= 85 years old, who have active disease that meets 2008 IWCLL/NCI-WG criteria to initiate treatment.
- 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.
- At least 21 days from last cytotoxic chemotherapy.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) \<2.
- 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.
- Adequate renal function, defined as serum creatinine \<2 x ULN.
- Able to provide written informed consent, and agree to practicing 2 forms of birth control during the study.
- 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
- Surface ROR1 expression by \<5% of CLL cells.
- 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.
- Patients with known systemic allergy to bovine or murine products.
- Known positive serology for human immunodeficiency virus (HIV) or human anti-mouse antibody (HAMA).
- Active, uncontrolled autoimmune phenomenon autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura (AIHA, ITP) requiring steroid therapy.
- Presence of \>/= Grade 3 non-hematologic toxicity common terminology criteria (CTC) version 4 from the previous treatment.
- Concurrent use of investigational therapeutic agent.
- Prior allogeneic hematopoietic stem-cell transplantation if evidence of donor chimerism persists. Patients with exclusively autologous hematopoiesis are eligible.
- Refusal to participate in the long-term follow-up protocol (2006-0676).
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02194374
Start Date
January 1 2015
End Date
June 1 2017
Last Update
June 12 2017
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