Tag: CLL

FDA Grants Breakthrough Therapy Designation to Venetoclax for Patients with Relapsed/Refractory CLL with 17p Deletion

Earlier today the FDA granted the Breakthrough Therapy Designation to venetoclax (ABT-199). Venetoclax was awarded this designation for the treatment of relapsed or refractory CLL in previously treated patients with 17p deletion. Venetoclax is an inhibitor of the B-cell lymphoma-2 (BCL-2) protein.

The Breakthrough Therapy Designation is intended to expedite the development and review of drugs for life-threatening conditions, based on preliminary clinical evidence. A full list of targeted treatments that have received FDA approval for the treatment of lymphoma can be found here.

Currently the Lymphoma Program has several phase 2 trials open to accrual for ABT-199 as a treatment for CLL patients. Dr. Richard Furman is the principal investigator for both trials:

Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Subjects with Relapse or Refractory to B-cell Receptor Signaling Pathway Inhibitor Therapy

Phase 2 Open-Label Study of the Efficacy of ABT-199 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion

A full listing of available CLL trials can be found here. Look to this space for more information regarding developments for the treatment of CLL.

New Clinical Trial: Phase 2 Open-Label Study of the Efficacy & Safety of ABT-199 in CLL Subjects with Relapsed or Refractory to B-cell Receptor Signaling Pathway Inhibitor Therapy

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with Chronic Lymphocytic Leukemia (CLL). The study sponsor is AbbVie, and the principal investigator at Weill Cornell is Richard Furman, M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 and older.
  • Diagnosis of CLL that is relapsed/refractory with an indication for treatment.
  • Disease is refractory or relapsed after therapy with ibrutinib or idelalisib.
  • Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with CLL that is relapsed/refractory to B-cell receptor (BCR) signaling pathway inhibitor therapy, specifically idelalisib or ibrutinib.

In recent years, clinical trials with idelalisib and ibrutinib have shown very encouraging results and each have gained FDA approval in specific patient populations, however, some subjects develop progressive disease or resistance after a period of time on these treatments. The study drug ABT-199 is a Bcl-2 family protein inhibitor that has shown a favorable benefit to risk ratio and strong activity in subjects with refractory CLL in clinical data to date, and has a mechanism of action that is independent of the BCR pathway. This study will provide more information about whether ABT-199 can benefit patients with CLL that is relapsed/refractory to idelalisib or ibrutinib.

Subjects will receive ABT-199 orally once daily, continuously throughout the study (up to 2 years following the date of the last subject enrolled) as long as they are responding to therapy and not experiencing unacceptable side effects. After discontinuing treatment, follow-up information will be collected every 3 months at clinic visits or through telephone calls for up to 3 years.

Subject will be eligible for reimbursement for travel expenses, and for lodging expenses incurred by the spouse/caregiver who provides transportation and/or assistance during study required hospital stays.

Ibrutinib Demonstrates Continued Efficacy for CLL Patients at 3 Year Follow-up

Previous studies have demonstrated the efficacy ibrutinib (Imbruvica), an oral inhibitor of Bruton’s tyrosine kinase, has as treatment for patients with CLL. This has led to its approval by the FDA for previously treated patients with CLL and patients with CLL who have deletion 17p regardless of prior therapy. In a paper published online in Blood, a group of investigators, including Richard R. Furman, published long term follow up results from the original phase II studies of ibrutinib in patients with CLL. The paper presents results from a median three-year follow-up of 132 treatment-naive and relapsed/refractory symptomatic patients with CLL or SLL, receiving single agent ibrutinib. Longer treatment with ibrutinib was associated with improvement in response quality, durable remissions, and with diminishing toxicity and adverse side effects. For the treatment naïve group of patients, the 30 month progression free survival was 96%. For the relapsed refractory patients, the 30 month PFS was 69%, with disease progression being seen primarily in the patients with relapsed del(17)(p13.1) and/or del(11)(q22.3) disease. Findings from this study provide further evidence that ibrutinib is an effective and well tolerated long-term treatment for patients with CLL.

A full listing of available CLL trials at WCMC can be found here. Please look to this space for further developments about ibrutinib and CLL trials.