Overview
CLLR3: Bendamustine + GA101 (BG) in Relapsed or Refractory CLL Followed by GA101 Maintenance for Responding Patients
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2022-09-01
2022-09-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
A Prospective, Multicenter, Randomized Phase-Ii Trial Comparing Efficacy And Safety Of Fludarabine + Cyclophosphamide + Ga101 (Fcg) And Bendamustine + Ga101 (Bg) In Patients With Relapsed Or Refractory Cll Followed By Maintenance Therapy With Ga101 For Responding PatientsPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Munich Municipal HospitalCollaborator:
German CLL Study GroupTreatments:
Bendamustine Hydrochloride
Obinutuzumab
Criteria
Inclusion Criteria:1. Diagnosis of CLL in need of treatment according to the iwCLL guidelines
2. Relapsed or refractory disease after at least one, but no more than 3 prior regimens
for CLL
3. Medically fit patients without relevant comorbidity, defined as total CIRS score ≤6
(single score < 4 for one organ category)
4. ECOG performance status of 0 - 2
5. Hematology values within the following limits unless cytopenia is caused by the
underlying disease, i.e. no evidence of additional bone marrow dysfunction (e.g.
myelodysplastic syndrome (MDS), hypoplastic bone marrow due to toxicity of prior
therapy):
1. Absolute neutrophil count ≥1.5 x 109/L
2. Platelets ≥50 x 109/L and more than 7 days since last transfusion
6. Creatinine clearance >60 ml/min calculated according to the modified formula of
Cockcroft and Gault or directly measured after 24 h urine collection
7. Adequate liver function as indicated by a total bilirubin, AST, and ALT ≤2 the
institutional ULN value, unless directly attributable to the patient's CLL
8. Negative serological Hepatitis B test (i.e. HBsAg negative and anti-HBc negative,
patients positive for anti-HBc may be included if PCR for HBV DNA is negative);
negative testing of Hepatitis C RNA; negative HIV test within 6 weeks prior to
registration
9. 18 years of age or older
10. Life expectancy >6 months
11. Able and willing to provide written informed consent and to comply with the study
protocol procedures
Exclusion Criteria:
1. Detected del(17p) or TP53 mutation
2. Refractoriness to FCR / BR
3. Transformation of CLL to aggressive NHL (Richter's transformation)
4. Known central nervous system (CNS) involvement
5. Evidence of significant uncontrolled concomitant disease
6. Major surgery < 30 days before screening
7. Decompensated hemolytic anemia 28 days before screening
8. Hemolytic cystitis 28 days before screening
9. Patients with a history of confirmed PML
10. Prior treatment with GA101
11. History of prior malignancy, except for conditions as listed below (a-d) and if
patients have recovered from the acute side effects incurred as a result of previous
therapy:
1. Malignancies treated with curative intent and with no known active disease
present for ≥ 2 years before registration
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease at screening
3. Adequately treated cervical carcinoma in situ without evidence of disease at
screening
4. Surgically adequately treated low grade, early stage localized prostate cancer
without evidence of disease at screening
12. Use of investigational agents or concurrent anticancer treatment within the last 4
weeks before registration
13. Patients with active infection requiring systemic treatment
14. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies and/ or known hypersensitivity to any constituent of the product
15. Hypersensitivity to fludarabine, cyclophosphamide, bendamustine, GA101 and/ or to any
of the excipients for example mannitol
16. An individual organ/ system impairment score of 4 as assessed by the CIRS definition
limiting the ability to receive an intensive therapy for CLL
17. Legal incapacity
18. Women who are pregnant or lactating
19. Fertile men or women of childbearing potential unless:
1. surgically sterile or ≥2 years after the onset of menopause
2. willing to use a highly effective contraceptive method (Pearl Index <1) such as
those listed at section 4.2.2 Exclusion criteria during study treatment and for
12 months after end of study treatment
20. Vaccination with a live vaccine within a minimum of 28 days before screening
21. Participation in any other clinical trial which would interfere with the study drug
22. Prisoners or subjects who are institutionalized by regulatory or court order
23. Persons who are in dependence to the sponsor or an investigator