Table of ongoing and upcoming clinical trials
Table of ongoing and upcoming clinical trials
Table of ongoing and upcoming clinical trials
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Date Modified 23/Nov/12<br />
Type<br />
Setting/Conditi<br />
on<br />
Line Study title<br />
A multi-center, open-label, Phase IB <strong>of</strong><br />
escalating doses <strong>of</strong> RO5045337<br />
administered orally, with cytarabine<br />
administered A) subcutaneously, or B)<br />
intravenously, in patients with acute<br />
Sponsor Sponsor #<br />
AML<br />
myelogenous leukemia (AML) Roche NP28023 CR1203RE JGH<br />
AML M4 <strong>and</strong><br />
M5<br />
AML<br />
MDS<br />
ET <strong>and</strong> PV<br />
PV<br />
CLL newly<br />
diagnosed<br />
CLL<br />
DLBCL newly<br />
diagnosed<br />
DLBCL relapsed<br />
Lymphoma (FL,<br />
MZL, SLL)<br />
Mantle Cell<br />
Lymphoma<br />
A Phase I/II Study <strong>of</strong> Ribavirin <strong>and</strong> Lowdose<br />
Cytarabine Arabinoside (Ara-C) in<br />
Acute Myeloid Leukemia (AML) M4 <strong>and</strong><br />
M5 Subtypes, <strong>and</strong> AML With High eIF4E<br />
Expression<br />
A Three-part Study <strong>of</strong> Eltrombopag in<br />
Thrombocytopenic Subjects<br />
With Myelodysplastic Syndromes or<br />
Acute Myeloid Leukemia (Part 1: Openlabel,<br />
Part 2: R<strong>and</strong>omized, Double-blind,<br />
Part 3: Extension)<br />
Leukemia<br />
<strong>and</strong><br />
Lymphoma<br />
Society<br />
Mcgill or<br />
CRU # Hospital<br />
Ribavirin-<br />
002 CR0903KB JGH Dr. Assouline<br />
GlaxoSmithKl<br />
ine 114968 CR1110GSK JGH<br />
A R<strong>and</strong>omized Phase II, Open-Label Study<br />
<strong>of</strong> the Efficacy <strong>and</strong> Safety <strong>of</strong> Orally<br />
Administered SAR302503 in Patients With<br />
Polycythemia Vera (PV) or<br />
Essential Thrombocythemia (ET) Who Are San<strong>of</strong>i-<br />
Resistant or Intolerant to Hydroxyurea Aventis ARD12042 CR1117SS JGH<br />
R<strong>and</strong>omized, open label, multicenter<br />
phase III study <strong>of</strong> Efficacy <strong>and</strong> Safety in<br />
Polycythemia vera subjects who are<br />
resistant to or intolerant <strong>of</strong> hydroxyurea:<br />
JAK inhibitor INC424 tablets versus best<br />
available care (The RESPONSE Trial)<br />
An Adaptive, Comparative, R<strong>and</strong>omized,<br />
Parallel-group, Multi Center, Phase Ib<br />
Study <strong>of</strong> Subcutaneous (SC) Rituximab<br />
Versus Intravenous (IV) Rituximab Both in<br />
Combination With Chemotherapy<br />
(Fludarabine <strong>and</strong> Cyclophosphamide), in<br />
Patients With Previously Untreated CLL<br />
Incyte<br />
Corporation<br />
Novartis<br />
A Phase 2 Open-label Study <strong>of</strong> MEDI-551<br />
<strong>and</strong> Bendamustine vs Rituximab <strong>and</strong><br />
Bendamustine in Adults With Relapsed or MedImmune<br />
Refractory CLL<br />
LLC<br />
A Phase III, Multicenter, Open-Label,<br />
R<strong>and</strong>omized Trial Comparing The Efficacy<br />
Of Ga101 (Ro5072759) In Combination<br />
With Chop (G-Chop) Versus Rituximab<br />
And Chop (R-Chop) In Previously<br />
Untreated Patients With CD20-Positive<br />
Diffuse Large B-Cell Lymphoma (DLBCL)<br />
CINC424B2<br />
301 CR1101NS JGH<br />
H<strong>of</strong>fmann-La<br />
Roche BO25341 CR1014RE JGH<br />
H<strong>of</strong>fmann-La<br />
Roche<br />
Limited<br />
CD-ON-<br />
MEDI-551-<br />
1019 CR1119ME JGH<br />
BO21005<br />
(GOYA) McG 1113 JGH<br />
Main PI <strong>and</strong> PI<br />
at JGH CRA at JGH<br />
Contact<br />
Info 514-<br />
340-8222<br />
Dr. Sarit<br />
Assouline Sally Behjoudi ext. 2075<br />
Caroline<br />
Lambert ext. 4599<br />
Dr. Sarit<br />
Assouline Sally Behjoudi ext. 2075<br />
Dr. Shireen<br />
Sirhan Sally Behjoudi ext. 2075<br />
Dr. Jaroslav<br />
Prchal Sally Behjoudi ext. 2075<br />
Dr. Sarit<br />
Assouline<br />
A R<strong>and</strong>omized Phase II Study <strong>of</strong> Oral<br />
Panobinostat (LBH589) With or Without<br />
Rituximab to Treat Relapsed or Refractory<br />
CR1010-QC-<br />
B-cell Non-Hodgkin Lymphoma Q-CROC Q-CROC-02 02 JGH Dr. Assouline<br />
An Open-Label, Multicenter, R<strong>and</strong>omized,<br />
Phase III Study to Investigate the Efficacy<br />
<strong>and</strong> Safety <strong>of</strong> Bendamustine Compared<br />
With Bendamustine+RO5072759 (GA101)<br />
in Patients With Rituximab-Refractory,<br />
Indolent Non-Hodgkin's Lymphoma Genentech GAO4753g CR1001GH JGH Dr. Assouline<br />
A Phase II Study <strong>of</strong> AT7519M, a CDK<br />
Inhibitor, in Patients with Relapsed<br />
Mantle Cell Lymphoma<br />
ACTIVELY RECRUITING HEMATOLOGY TRIALS<br />
Caroline<br />
Lambert ext. 4599<br />
Dr. Sarit<br />
Assouline Sally Behjoudi ext. 2075<br />
Dr. Nathalie<br />
Johnson Matt Adamski ext. 3766<br />
Rosa<br />
Christodoulopo<br />
ulos ext. 6823<br />
Caroline<br />
Lambert ext. 4599<br />
NCIC Clinical<br />
Trials Group IND 194 JGH Dr. Assouline Matt Adamski ext. 3766<br />
Prepared by Tasnim Daginawala<br />
Study<br />
status Start date<br />
Recruite<br />
d to<br />
date<br />
Active<br />
Recruiting Jun-12 3<br />
Active<br />
HMR 7<br />
Recruiting Mar-10 JGH 16<br />
Active<br />
Recruiting<br />
STATS<br />
Rec.<br />
Target<br />
Dec2011<br />
Part 2 since<br />
Sep2012 1 2<br />
Active<br />
Recruiting Jan-12 1<br />
Active<br />
Recruiting Mar-11 1<br />
Active<br />
Recruiting Apr-11 4<br />
Active<br />
Recruiting 09-Nov-12 0<br />
Active<br />
Recruiting 27-Sep-11 2 10<br />
Active<br />
Recruiting Jan-11 7<br />
Active<br />
8<br />
1<br />
potenti<br />
Recruiting Jul-10 al pt 4<br />
Active<br />
Recruiting 21-Nov-12 0<br />
1 <strong>of</strong> 2
Type<br />
Setting/Conditi<br />
on<br />
Line Study title Sponsor Sponsor #<br />
PTCL relapsed<br />
AML<br />
CML<br />
CLL<br />
CLL<br />
CLL<br />
NHL<br />
DLBCL relapsed<br />
A Phase 3, R<strong>and</strong>omized, Two-Arm, Open-<br />
Label, Multicenter, International Trial <strong>of</strong><br />
Alisertib (MLN8237) or Investigator’s<br />
Choice (Selected Single Agent) in Patients<br />
with Relapsed or Refractory Peripheral T-<br />
Cell Lymphoma<br />
A Phase III R<strong>and</strong>omised, Double-Blind,<br />
Controlled, Parallel Group Study Of<br />
Intravenous Volasertib In Combination<br />
With Subcutaneous Low-Dose<br />
Cytarabine Vs. Placebo + Low-Dose<br />
Cytarabine In Patients ≥ 65 Years With<br />
Previously Untreated Acute Myeloid<br />
Leukaemia, Who Are Ineligible For<br />
Intensive Remission Induction Therapy<br />
A Phase 3 R<strong>and</strong>omized, Open-Label Study<br />
Of Ponatinib Versus Imatinib In Adult<br />
Patients With Newly Diagnosed Chronic<br />
Myeloid Leukemia In Chronic Phase<br />
R<strong>and</strong>omized, Double-blind, Placebocontrolled<br />
Phase 3 Study <strong>of</strong> Ibrutinib, a<br />
Bruton's Tyrosine Kinase (BTK) Inhibitor,<br />
in Combination with Bendamustine <strong>and</strong><br />
Rituximab (BR) in Subjects With Relapsed<br />
or Refractory Chronic Lymphocytic<br />
Leukemia / Small Lymphocytic<br />
Lymphoma.<br />
Millennium<br />
Pharmaceuti<br />
cals C14012 McG 1218<br />
Mcgill or<br />
CRU # Hospital<br />
RVH<br />
JGH<br />
Boehringer<br />
Ingelheim 1230.14 McG 1222 JGH<br />
ARIAD<br />
Pharmaceuti<br />
cals<br />
Janssen<br />
Research &<br />
Development<br />
LLC<br />
A Study To Evaluate The Efficacy And<br />
Safety Of Dinaciclib Or Ofatumumab In<br />
Subjects With Refractory Chronic<br />
Lymphocytic Leukemia (CLL) Merck<br />
An Open-Label, Multicenter, Phase I Trial<br />
<strong>of</strong> the Safety <strong>and</strong> Pharmacokinetics <strong>of</strong><br />
Escalating Doses <strong>of</strong> DCDS4501A in<br />
Patients With Relapsed or Refractory B-<br />
Cell Non Hodgkin's Lymphoma <strong>and</strong><br />
Chronic Lymphocytic Leukemia<br />
Genentech/R<br />
oche<br />
AP24534-<br />
12-301 McG 1221 JGH<br />
PCI-32765-<br />
CLL3001 (“<br />
HELIOS”<br />
trial) McG 1230 JGH<br />
MK-7965-<br />
012-02 McG 1232 JGH<br />
DCS4968g<br />
GO01294 CR1104GN JGH<br />
A R<strong>and</strong>omized, Open Label, Multicenter,<br />
Phase II Trial Evaluating the Safety <strong>and</strong><br />
Activity <strong>of</strong> DCDT2980S in Combination<br />
with Rituximab or DCDS4501A in<br />
combination with Rituximab in patients<br />
with Relapsed or Refractory B-Cell Non-<br />
Hodgkins Lymphoma Genentech GO27834 CR1206 JGH<br />
Main PI <strong>and</strong> PI<br />
at JGH CRA at JGH<br />
Contact<br />
Info 514-<br />
340-8222<br />
Dr. Sarit<br />
Assouline Matt Adamski ext. 3766<br />
UPCOMING HEMATOLOGY TRIALS<br />
Dr. John<br />
Storring Matt Adamski ext. 3766<br />
Study<br />
status Start date<br />
Recruite<br />
d to<br />
date<br />
Rec.<br />
Target<br />
Active<br />
Recruiting 15-Oct-12 2 in scr 10<br />
Pending IRB<br />
approval<br />
Dr. Sarit<br />
Assouline Matt Adamski ext. 3766 Pending SIV<br />
Dr. Sarit<br />
Assouline Matt Adamski ext. 3766<br />
Dr. John<br />
Storring Matt Adamski ext. 3766<br />
Dr. Sarit<br />
Assouline Dennis Baltzis ext. 3628<br />
Pending IRB<br />
approval<br />
Pending IRB<br />
approval<br />
On hold<br />
(CLL on<br />
hold, other<br />
cohorts<br />
closed) Jun-11 10<br />
Dr. Sarit<br />
Assouline Dennis Baltzis ext. 3628 Pending SIV 23-Nov-12<br />
Prepared by Tasnim Daginawala 2 <strong>of</strong> 2
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