Trial Roundup
ASH Clinical News’ Associate Editors select
clinical trials to keep an eye on.
LEUKEMIA
LYMPHOMA & MYELOMA
David Steensma, MD
Dana-Farber Cancer Institute
Keith Stewart, MBChB, MBA
Mayo Clinic, Arizona
A Safety Study of SGN-CD33A in
Combination With Standard-of-care in
Patients With AML (NCT02326584)
Study Evaluating ABT-199 in Subjects With
Relapsed or Refractory Multiple Myeloma
study design: Non-randomized, open-label, parallelassignment 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
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
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in 2000, but it was withdrawn in June 2010 because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 inc luding 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 antibodydrug 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.
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.
(NCT01794520)
A Phase II Trial of Oncolytic Virotherapy
by Systemic Administration of Edmonston
Strain of Measles Virus (NCT02192775)
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, NonHodgkin Lymphoma, or Multiple Myeloma
(NCT01421524)
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.
New and
Improved!
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: 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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ASH Clinical News
October 2015