Phase 2
Completed N=34
Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Source: ClinicalTrials.gov NCT00974233 ↗Enrolled (actual)
34
Serious AEs
41.5%
Results posted
Jul 2017
Primary outcomePrimary: Progression Free Survival — 18.3 months
Summary
The purpose of this research is to evaluate a new combination of chemotherapy drugs for CLL/SLL using the drugs bendamustine (an intravenous chemotherapy drug), rituximab (an intravenous medication called a monoclonal antibody), and lenalidomide (an anti-cancer pill).
The purpose of this study is to see if giving the chemotherapy pill lenalidomide after treatment with bendamustine and rituximab is able to prolong the period of time before the cancer starts growing again and causing symptoms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
18.3 | — |
| PRIMARY Progression-free Survival |
0.62; 0.35; 0.23 | — |
| SECONDARY Objective Response Rate (Complete + Partial Responses) |
7; 12; 9; 19 | — |
| SECONDARY Toxicities Observed With Induction Chemotherapy and Maintenance Therapy |
5; 6; 5; 1; 6; 7 | — |
| SECONDARY Overall Survival |
42.8 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed, CLL/SLL, documented relapsed or refractory disease after at least one prior chemotherapy regimen.
- In cases of SLL, patients must have at least one bidimensionally measurable lesion at least ≥1.5 cm measured in one dimension.
- ECOG performance status of 0-2 at study entry
- Laboratory test results within these ranges: ANC 60 mL/min as determined by the Cockcroft-Gault calculation.
- Total bilirubin 5 lines of prior therapy for their disease. Re-treatment with an identical regimen does not count as a new regimen.
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or comply with the protocol treatment.
- Pregnant or breast feeding females. Lactating females must agree not to breast feed while taking lenalidomide.
- Prior history or current evidence of central nervous system or leptomeningeal involvement.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Known hypersensitivity to thalidomide.
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known to be positive for HIV or infectious hepatitis, type B or C.
Data sourced from ClinicalTrials.gov (NCT00974233). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.