Tag: cancer clinical trials

Palbociclib and One Researcher’s Resolve

Palbociclib is a selective CDK4/6 inhibitor approved by the FDA for the treatment of patients with breast cancer. Currently it’s being tested in phase I trials for the treatment of patients with mantle cell lymphoma. The use of palbociclib as a cancer treatment was championed by Selina Chen-Kiang, PhD., professor of Pathology & Laboratory Medicine and Microbiology & Immunology, and a key collaborator with the Lymphoma Program. Palbociclib is currently considered one of the next big things in cancer treatment. But:

“..it’s old news for Selina Chen-Kiang, Ph.D…who has been a cheerleader for palbociclib for the past decade. In fact, her relentless effort helped resurrect the drug after it was shelved by an uninterested pharmaceutical company, and her initial findings inspired the clinical trials that paved the path for its accelerated approval.”    

“Chen-Kiang is renowned for her research in immunology and hematological malignancies. A molecular biologist by training, she first got swept into myeloma and lymphoma research while studying how antibody-secreting plasma cells were generated from B cells. Unlike solid tissue, normal immune cells can be isolated at different stages from mice and humans, making them the perfect model to study her primary passion: cell cycle control of immunity.”

Today Dr. Chen-Kiang’s dogged inquiry into the potential of palbociclib has the potential to help cancer patients. Her resolve exemplifies the bench portion of our bench to bedside approach at the Meyer Cancer Center. Palbociclib is currently undergoing phase I investigator-initiated trials, sponsored by the Cancer Therapy Evaluation Program at the National Cancer Institute at Weill Cornell Medical College. The principle investigator is Dr. Peter Martin. You can listen to him explain explain the benefits of this recently initiated trial:

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.

New Clinical Trial: Phase 3 Study of Ibrutinib in Combination with Either Bendamustine and Rituximab or R-CHOP in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with follicular and marginal zone lymphoma. The study sponsor is Janssen Research & Development LLC., and the principal investigator at Weill Cornell is Peter Martin, 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

  • Open to men and women age 18 and older.
  • Follicular or Marginal Zone, non-Hodgkin lymphoma.
  • Relapsed or Refractory after receiving at least one prior chemotherapy regimen.
  • At least one site of measurable disease.
  • Detailed eligibility reviewed when you contact the study team.

Study Details 

This clinical trial is for men and women with follicular or marginal zone lymphoma who have been previously treated.

The purpose of this study is to compare whether adding ibrutinib to the standard chemotherapy options for this population bendamustine/rituximab (BR) or R-CHOP result in a longer progression-free survival than BR or R-CHOP alone.

The type of chemotherapy received will be dependent on refractory versus relapsed disease, type of indolent non-Hodgkin lymphoma, and number of prior lines of therapy.

All participants will be randomized in a one to one ratio to receive the study drug, ibrutinib, or placebo.

Randomization arms: This study is comparing BR or R-CHOP in combination with ibrutinib or placebo. This is a double blind study so neither the patient or the physician will know if you’re receiving the study medication, ibrutinib or placebo. Placebo is a blank pill that will look similar to ibrutinib but contains no medicine. The physicians will decide whether patients will receive BR or R-CHOP chemotherapy depending on prior treatments.

Patients will receive the standard 6 cycles of BR or R-CHOP and will continue taking ibrutinib or placebo as long as they are responding to therapy and not experiencing unacceptable side effects.