Chronic Lymphocytic Leukaemia Clinical Trial
Official title:
A Single Arm Phase II Study to Investigate the Use of Lenalidomide in the Treatment of Patients With Early Stage CLL Associated With Poor Prognostic Factors
The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or Rai stage 0/I). Standard management of such patients is observation, and with median age at diagnosis of 72 and median time to progression of >5-10 years, many will never require treatment. In contrast, a proportion of patients have more aggressive disease, and over the last decade, a number of molecular factors have been identified that may be used to identify patients with poor prognosis disease . Each is associated with shortened time to treatment (typically less than 3 years in patients with 2 of more factors), reduced survival, with in the case of p53/ATM inactivation, resistance to treatment. Whether it is possible to improve the outcome of patients with CLL and adverse prognostic factors by early intervention with treatment is unknown. Several trials in the 1980's demonstrated that treatment of stage A CLL with conventional chemotherapy (chlorambucil) did not alter the natural history of the disease, although none of these studies stratified patients according to risk. The choice of alternative potential therapeutic agents is limited; they should be effective in patients with adverse prognostic factors, have acceptable toxicity, be able to overcome the drug resistance associated with p53/ATM inactivation and ideally be orally administered. Two recent phase II trials have demonstrated that Lenalidomide is effective in the treatment of relapsed/refractory disease. Importantly, both studies included a high proportion of patients with adverse prognostic factors including p53 inactivation. The principle objective of this study is to investigate the efficacy of Lenalidomide in achieving disease response (complete remission and clearance of minimal residual disease) in patients with poor risk early stage disease, together with assessment of safety and tolerability.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03582098 -
Clinical Outcomes and Routine Management of Adults With Chronic Lymphocytic Leukaemia Treated With Idelalisib and Rituximab in the United Kingdom (UK) and Ireland
|
||
| Recruiting |
NCT06357754 -
Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy
|
||
| Completed |
NCT02933320 -
BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT02267590 -
Tissue Collection for Biomarkers Determining Resistance to Ibrutinib
|
N/A | |
| Completed |
NCT01832597 -
Efficacy and Safety Study of Bendamustine With or Without Rituximab in Chronic Lymphoproliferative Disorders
|
N/A | |
| Recruiting |
NCT04763083 -
First in Human Study of NVG-111 in Relapsed/Refractory ROR1+ Malignancies
|
Phase 1 | |
| Completed |
NCT01597219 -
Trial of Haploidentical Stem Cell Transplantation for Haematological Cancers
|
Phase 2 | |
| Withdrawn |
NCT00504491 -
R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
| Terminated |
NCT01446900 -
R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma
|
Phase 2 | |
| Recruiting |
NCT01678430 -
A Trial Looking at Ofatumumab for People With Chronic Lymphocytic Leukaemia Who Cannot Have More Intensive Treatment
|
Phase 3 | |
| Terminated |
NCT00751296 -
Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL)
|
Phase 2 | |
| Completed |
NCT01659255 -
Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL
|
Phase 1 | |
| Recruiting |
NCT04728893 -
Efficacy and Safety of Nemtabrutinib (MK-1026) in Participants With Hematologic Malignancies (MK-1026-003)
|
Phase 2 | |
| Completed |
NCT01805375 -
A Phase I Trial of DI-B4 in Patients With Advanced CD19 Positive Indolent B-cell Malignancies
|
Phase 1 | |
| Completed |
NCT00457782 -
A Phase I Safety, PK and PD Study of KW-2478 in Patients With Multiple Myeloma, Chronic Lymphocytic Leukaemia or B-cell Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00292760 -
A Single-arm Phase II Study of Alemtuzumab in Combination With High-dose Methylprednisolone in CLL Patients With p53 Deletion
|
Phase 2 |