Clinical Trials

Last Updated: 4/4/2013

Leukemia Clinical Trials are Grouped by Disease Type:

• Phase I Agents
• Acute Lymphoblastic Leukemia 
• Acute Myelogenous Leukemia
• Myelodysplastic Syndromes 
• Chronic Lymphocytic Leukemia
• Chronic Myelogenous Leukemia
• Myeloproliferative Diseases

Phase I Agents

• L-Grb2 Antisense Oligonucleotide (ALL, AML, MDS, CML) (2003-0578)
• A-dmDT390-bisFv (UCHT1) Fusion Protein (ALL, CLL) (2008-0077)
• G-CSF & Plerixafor + Sorafenib (AML) (2008-0501)
• Hyper-CVAD + RAD001 (everolimus) (ALL) (2009-0100)
• Vidaza + Revlimid (AML, MDS) (2009-0467)
• Plerixafor + Clofarabine (AML) (2009-0536)
• Randomized Aza +/- LBH (AML, MDS) (2009-0619)
• Nelarabine (2009-0717)
• ABT-348 (AML, ALL, CLL, CML, MDS) (2009-0788)
• LY2784544 (MDP) (2010-0167)
• TH-302 (ALL, AML, MDS, CLL, CML, MPD) (2010-0268)
• PCK412 and AZA (AML, MDS) (2010-0374)
• KB004 (ALL, AML, MDS, CLL, CML, MPD) (2010-0509)
• Sorafenib + 5 Aza (AML, MDS) (2010-0511)
• SGI-110 (AML, MDS) (2010-0615)
• CIA vs FLAI (2010-0788)
• BKM120 (ALL, AML) (2010-0874)
• INC424 (MPD) (2010-0964)
• PM01183 (AML, ALL, MDS, CML) (2010-0965)
• Plerixafor + G-CSF (AML) (2011-0036)
• AC220 (ASP2689) (AML, CML) (2011-0041)
• Ara-C + Tosedostat (AML, MDS) (2011-0188)
• CWP232291 (AML) (2011-0253)
• Dasatinib + DAC (2011-0333)
• AMG 900 (AML, ALL, MDS, CML) (2011-0369)
• BMS-906024 -Notch inhibitor (ALL) (2011-0382)
• PRI-724 (AML, CML, MDS, MPD) (2011-0527)
• MK-8242 (AML) (2011-0547)
• AZD1208 (AML, MDS, MPN, CML) (2011-0816)
• ARRY-614 (MDS) (2011-0827)
• Rituximab (ALL) (2011-0844)
• DAC + Clofarabine + IDA + Ara-C (2012-1064)
• DFP-10917 (ALL, AML) (2012-0262)
• TRU-016 + Rituximab (2012-0626)
• IPI-145 (2012-1040)

Acute Lymphoblastic Leukemia (ALL)

Newly Diagnosed or Previously Treated 

• Augmented Berlin-Frankfurt-Munster (2006-0375)
• Hyper-CVAD + Ofatumumab (2010-0708)
• Marqibo (2011-1071)
• Hyper-CVAD + Inotuzumab Ozogamycin (CMC-544) (2010-0991)
• Hyper-CVAD + Nelarabine (2006-0328)
• Hyper-CVAD + Ponatinib +/- Rituximab (2011-0030)
• Hyper-CVAD + Dasatinib (SWOG0805)

Salvage Programs

• Inotuzumab Ozogamicin (2012-0151)
• Blinatumomab (BiTE) (2011-0784)
• SAR 3419 (2011-0287)
• BKM120 (2010-0874)
• Rituximab (ALL) (2011-0844)
• Hyper-CVAD + Dasatinib (2006-0478)
• BKM120 (2010-0874)
• Nelarabine (2009-0717)
• PF-03084014 (2010-0317)
• BMS-906024 - Notch inhibitor (2011-0382)
• A-dmDT390-bisFv (UCHT1) Fusion Protein (ALL, CLL) (2008-0077)
• BKM120 (2010-0874)
• Hyper-CVAD + RAD001 (everolimus) (2009-0100)
• MOAD (2008-0267)
• Hyper-CVAD + Inotuzumab Ozogamycin (CMC-544) (2010-0991)
• Rituximab (ALL) (2011-0844)

Acute Myelogenous Leukemia (AML)

Newly Diagnosed

• Fludarabine, Ara-C, G-CSF and Gemtuzumab Ozogamicin (2007-0147) 
• ATRA and arsenic +/- Gemtuzumab Ozogamicin (2010-0981)
• AC220 (ASP2689) (2011-0041)
• CIA vs FLAI (2010-0788)
• PF-04449913 (2012-0062)
• LD Ara-C + Lintuzumab-Ac225 (2012-0434)
• Omacetazine + LD Ara-C (2010-0736)
• DAC (2012-1017)
• Plerixafor + Clofarabine (2009-0536)
• Cladribine + LD Ara-C alternating DAC (2011-0987)
• Sorafenib + 5 Azacitidine (2010-0511)
• Vidaza + Revlimid  (2009-0467)
• PF-04449913 (2012-0062)
• SGI-110 (AML, MDS) (2010-0615)
• Sapacitabine alternating DAC (2010-0727)

    Newly Diagnosed FLT3 Mutated

• AC220 (ASP2689) (2011-0041
• G-CSF & Plerixafor + Sorafenib (2008-0501)

    Unfit for induction chemotherapy

• Vorinostat + Aza (2007-0685)

    Frontline AML Post-Hypomethylating Therapy for MDS

• PF-04449913 (2012-0062)
• LD Ara-C + Lintuzumab-Ac225 (2012-0434)
• Ara-C + Tosedostat (AML, MDS) (2011-0188)

Salvage

• Oral Tamibarotene (APL) (2007-0512)
• G-CSF & Plerixafor + Sorafenib (2008-0501)
• Crenolanib (2012-0569)
• PCK412 and AZA (2010-0374)
• Vosaroxin + Ara-C vs Placebo + Ara-C (2010-0692)
• Plerixafor + G-CSF (AML) (2011-0036)
• DAC + Clofarabine + IDA + Ara-C (2012-1064)
• CIA vs FLAI (2010-0788)
• Ondansetron vs Ondansetron + aprepitant (2008-0615)

Secondary Leukemia

• CPX-351 vs Ara-C + Daunorubicin (2012-0980)

Maintenance (Patients in CR)

• Oral AZA + BSC vs BSC as maintenance in AML in CR (2012-0866)

Myelodysplastic Syndrome (MDS) (Includes CMML)

• Oral AZA + BSC vs Placebo + BSC (2012-0733)
• DAC VS AZA (2012-0507)
• ARRY-614 (MDS) (2011-0827)
• Lenalidomide VS Placebo (2009-0737)
• PCK412 and AZA (2010-0374)
• Deferasirox (2010-0041)
• SGI-110 (AML, MDS) (2010-0615)

IPSS int-2 or high

• Vidaza + Revlimid (2009-0467)
• Randomized Azam +/- LBH (2009-0619)
• Randomized DAC alternating Clo vs DAC (2008-0092)
• SGI-110 (AML, MDS) (2010-0615)
• Sapacitabine alternating DAC (2010-0727)
• Cladaribine + LD Ara-C alt. DAC (2011-0987)
• Omacetazine + LD Ara-C (2010-0736)
• PF-04449913 (2012-0062)
• Plerixafor + Clofarabine (2009-0536)
• CIA vs FLAI (2010-0788)
• E7070 + Ida + Ara-C (2009-0570)
• CPX-351 vs Ara-C + Daunorubicin (2012-0980)

Chronic Lymphocytic Leukemia (CLL)

CLL Immunotherapy

Untreated - early stage

• Ofatumumab (2010-0241)

Untreated - all stages 

• FCR (2008-0431)
• TRU-016 + Rituximab (2012-0626)
• PCI-32765 + Heavy Water (2012-0086)
• Lenalidomide + Rituximab (2011-0509)
• Ofatumumab (2011-0520)

Mimimal Residual Disease

• Revlimid (2007-0213)

Prior Therapy

• 8-Chloro-Adenosine (2004-0144)
• Ibrutinib vs Ofatumumab (2012-0707)
• Lenalidomide + Rituximab (2011-0509)
• ABT-199 (2011-0164)
• Fludarabine + bendamustine + rituximab (2009-0546)
• Sapacitabine + Cyclophosphamide + Rituximab (2010-0516)
• AVL-292 (2011-0513)
• GS-1101 (CAL-101) (2012-0411)
• PCI - 32765 (Extension Study) (2011-0142LEUKEMIA)
• GS-1101 (CAL-101) (2012-0171)

Previously Treated with 17p Deletion

• PCI-32765 (Ibrutinib) (2012-1125)

Supportive Care

• Eltrombopag (2010-0123)

Other Studies

•  2CDA + Rituximab (2004-0223)

Chronic Myelogenous Leukemia (CML)

Chronic phase

• Ponatinib (2012-0074)
• BMS-354825 (2005-0422)
• Dasatinib (2005-0422)
• Oral AMN107 (2005-0048)
• Ponatinib (2012-0669)

Accelerated Phase

• Dasatinib + DAC (2011-0333)

Blastic Phase

• Dasatinib + DAC (2011-0333)
• MOAD (2008-0267)

Minimal Residual Disease

• PEG-IFNa-2a (2011-0184)
• Azacitidine (2011-0254)

Supportive Care

• Eltrombopag (2011-0319)

Other Studies

• Tryptophan Metabolism/Chronic Fatigue (2011-0559)

Myeloproliferative Diseases

• Ruxolitinib + AZA (2012-0737)
• Sotatercept (ACE-011) (2012-0534)
• Ruxolitinib + Revlimid (2011-0269)
• INCB039110 (2012-0035)
• SAR302503 (CMIF) (2011-0857)
• AB0024 (CIMF) (2011-0016)
• ruxolitinib (CIMF) (2011-0359)
• INC424 (CIMF) (2010-0964)
• IPI-145 (2012-1040)
• NS-018 (CIMF) (2011-0090)
• TH-302 (ALL, AML, MDS, CLL, CML, MPD) (2010-0268)
• BMS-911543 (CIMF) (2010-0782)
• PRI-724 (CIMF) (2011-0527)
• Ruxolitinib vs hydroxyurea (2012-0492)
• Masitinib vs Placebo (SM) (2008-0275)

MDS/MPD

• KB004 (2010-0509)

Previously Exposed to Ruxolitinib

• SAR302503 (2012-0065)

Supportive Care

• Ondansetron vs Ondansetron + aprepitant (2008-0615)
• Deferasirox (2010-0041)
• Eltrombopag (2011-0319)