Measles Virus in Myeloma, SGN-CD33A in AML, and more

LEUKEMIA
David Steensma, MD
Dana-Farber Cancer Institute

A Safety Study of SGN-CD33A in Combination With Standard-of-care in Patients With AML (NCT02326584)

  • Study Design: Non-randomized, open-label, parallel-assignment safety/efficacy study
  • Study Start Date: December 2014
  • Estimated Study Completion Date: December 2017
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 90
  • Sponsor: Seattle Genetics

Gemtuzumab ozogamicin, an anti-CD33 antibody-drug conjugate that has activity in AML, received accelerated approval by the U.S. Food and Drug Administration in 2000, but it was withdrawn in June 2010 because of regulatory agency concern about increased mortality rate and toxicities including hepatic veno-occlusive disease with gemtuzumab in the SWOG S0106 trial. Subsequent studies, such as ALFA 0701, have shown improved survival combining gemtuzumab with chemotherapy. While the regulatory path forward for gemtuzumab is unclear, SGN-CD33A is an antibody-drug conjugate with a different toxin, pyrrolobenzodiazepine (PBD), with a distinct adverse event profile from the calicheamicin toxin to which gemtuzumab is conjugated. This novel agent is being used both alone and in combination with standard therapies including cytarabine and anthracyclines in patients with AML.


LYMPHOMA & MYELOMA
Keith Stewart, MBChB, MBA
Mayo Clinic, Arizona

Study Evaluating ABT-199 in Subjects With Relapsed or Refractory Multiple Myeloma (NCT01794520)

  • Study Design: Non-randomized, single-group assignment, open-label safety study
  • Study Start Date: October 2012
  • Estimated Study Completion Date: August 2017
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 64
  • Sponsor: AbbVie

ABT-199 (venetoclax) is a small molecule inhibitor of the anti-apoptotic protein bcl-2 commonly expressed in B-cell malignancies. Early indicators are that this drug is active in chronic lymphocytic leukemia (CLL) and in selected patients with myeloma. This trial will unravel the response rate and genetic subtypes of patients who respond.

A Phase II Trial of Oncolytic Virotherapy by Systemic Administration of Edmonston Strain of Measles Virus (NCT02192775)

  • Study Design: Open-label, single-group assignment safety/efficacy study
  • Study Start Date: March 2015
  • Estimated Study Completion Date: August 2016
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 16
  • Sponsor: University of Arkansas

The use of measles virus in myeloma received significant media attention last year when a patient with advanced myeloma entered a complete remission after treatment. Immunosuppressed patients are most likely to be responsive due to their lack of measles antibodies. Although this is an early and explorative therapy, this and other ongoing trials will further explore the utility of measles virus oncolytic therapy.

Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT02048813)

  • Study Design: Randomized, open-label, parallel-assignment efficacy study
  • Study Start Date: February 2014
  • Estimated Study Completion Date: April 2017
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 519
  • Sponsor: National Cancer Institute

The results from this randomized phase III trial may lead to a change in the standard of care of CLL if ibrutinib and rituximab can be shown to be superior and less toxic than fludarabine, cyclophosphamide, and rituximab.

Study of CC-122 to Evaluate the Safety, Tolerability, and Effectiveness for Patients With Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Multiple Myeloma (NCT01421524)

  • Study Design: Non-randomized, single-group assignment, open-label safety/efficacy study
  • Study Start Date: September 2011
  • Estimated Study Completion Date: October 2016
  • Study Status: Currently recruiting participants
  • Estimated Enrollment: 160
  • Sponsor: Celgene Corporation

The newest of the immunomodulatory drugs (IMiD) that targets the E3ligase Cereblon pathway CC-122 is reputedly more potent than existing FDA-approved IMiD molecules and may have signs of early activity in hematologic malignancies, a possibility being examined in this phase I trial.

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