Clinical Trials of Interest

Last update: 01/27/2012

CLL/SLL | CNS Lymphoma | DLBCL | Follicular | Hodgkin | b-cell NHL Indolent b-cell NHL | Mantle Cell | T-cell Lymphomas See also Locate Trials by Type of Lymphoma & Treatment Status  or by Type of Agent Click here to send us your recommended trials, comments, or suggestions Audience and purpose: A tool for physicians, patients and caregivers.  An aid in the discussion of trials.
	Terms	Clinical rationale:  Why participation in the study could be reasonable as a treatment decision. You can follow the numbered link to 7 Reasons to Consider Trials based on clinical circumstances for details.
	and	Scientific rationale:  A composite score - our estimate of the potential of the study to change clinical practice or the clinical relevance of the study question - such as if it potentially addresses on unmet need.
	limitations	Need to Treat:  In general for indolent lymphoma when the Need to Treat is not specified in the eligibility criteria the results of the study may be less generalizable.
		Goal of therapy: an impression of the typical goal of therapy for the clinical indication, such as curative intent for aggressive lymphoma.  (A question mark (?) indicates that the potential to reach the goal is low or controversial.
Chronic Lymphocytic Leukemia  Small Lymphocytic Leukemia  (CLL/SLL)     (also indolent NHL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	CLL/SLL	PCI-32765 for Special Cases of CLL or SLL	Over 65 yrs with Need to Treat, OR any age with 17p or p53 risk factor	PCI-32765 a btk-inhibitor	Activity and safety of PCI-32765  an oral targeted drug for special cases of CLL/SLL	1, 4, 7	3	Management Reports
>	CLL/SLL	PCI-32765 With FCR or With BR in CLL or SLL	Need to Treat	btk-inhibitor with FCR or with BR	Safety of PCI-32765 an oral targeted drug when combined with competing standard chemos	1, 4, 7	3	Durable remission / cure? Reports
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Central Nervous System  Lymphoma (CNSL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	CNSL	Combination Chemo With or Without Autologous Stem Cell Transplant in Treating Patients With CNS B-Cell Lymphoma	Previously untreated; primary central nervous system (CNS) diffuse large B-cell lymphoma	Combination chemo with high-dose therapy and autologous SCT  vs. Combination chemo with consolidation chemo	"How well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma" - a high risk lymphoma	2, 7	4	Curative intent Reports
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Diffuse Large B-cell Lymphoma  (DLBCL) and PMBCL     (also B-cell NHL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	DLBCL	Rituxan and Combination Chemo Treating Patients with DLBCL	Previously Untreated	R-CHOP vs. R-EPOCH	Compare efficacy of Rituxan-based Chemos. Evaluate molecular predictors of outcome	2, 7	4, 7	Curative intent Reports
>	DLBCL	Navitoclax in Addition to B-R in Patients With Relapsed DLBCL	Relapsed; not eligible for high-dose chemo - with Stem Cell rescue	BCL-2 inhibitor with BR vs. BR	Compare Efficacy of Navitoclax with B-R chemo to B-R in patients ineligible for high dose therapy	4, 6	4	Curative intent
Follicular lymphoma (FL)     (also indolent NHL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	Follicular	Low-Dose MTX and Bexxar for Untreated, Advanced-Stage, Follicular	Untreated; Need to Treat not specified	Bexxar after low dose MTX chemo	Will using low-dose Methotrexate with Bexxar improve safety of Bexxar? Compare response rate to historical expectations	1	2	Durable remission  / cure? Reports
>	Follicular	Combination Veltuzumab and Fractionated 90Y- Epratuzumab Radioimmunotherapy in Follicular Lymphoma	Previously untreated with systemic therapy; measurable disease but not bulky  and not stage I/II.	CD20 antibody (Veltuzumab) followed by Fractionated cd22 (radio-labeled antibody - 90Y-Epratuzumab)	What is the efficacy and safety of novel (and non- competing) antibody-based therapy as first treatment	1, 4, 7	2	Durable remission / cure? Reports
>	Follicular	Rituximab and/or Lenalidomide in Treating Patients With Follicular Not Refractory to Rituximab	Relapsed; responsive to last Rituxan; Need to Treat not specified	Rituxan vs. Lenalidomide vs.  Lenalidomide + Rituxan	What is the efficacy (response rate and time to progression) and safety of Len-based treatment when added to or compared to Rituxan?	7	3	Management Reports
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Hodgkin Lymphoma (HL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	Hodgkin	Brentuximab Vedotin Before Autologous Stem Cell Transplant in Treating Patients With Hodgkin	Relapsed or refractory  to primary therapy;  cd30 expressed on tumor cells	brentuximab vedotin (BV)  an antibody-drug conjugate	Activity of BV  prior to autologous stem cell rescue	4, 6	4	Curative intent with less toxicity Reports
>	Hodgkin	Chemo Based on PET Scan in Treating Patients With Stage I or Stage II Hodgkin	Previously Untreated; non-bulky stage I/II	ABVD x2 then based on PET: ABVD x2 OR  BEACOPP x2 then IFRT (radiotherapy)	Can PET imaging predict who needs more aggressive BEACOPP chemo and IFRT therapy, and who can benefit from additional but less toxic ABVD?  (Response-adapted decision making)	3, 7	4	Curative intent with less toxicity Reports
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Mantle Cell Lymphoma (MCL)     (also indolent NHL | B-cell NHL)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	MCL	Safety and Efficacy of PCI-32765 in Relapsed / Refractory Mantle Cell Lymphoma	Previously Untreated; Did not achieve PR or had progression after most recent treatment	PC1-32765 - a oral agent that targets btk	How well can an oral targeted drug manage relapsed and refractory indolent lymphoma and for how long?	4, 6, 7	4, 7	Curative intent Reports
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B-cell NHL mixed types  (aggressive or indolent)				< Key Eligibility v Protocol / Agent	Study Questions of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	b-cell NHL, high-risk, many types	Genetically Engineered Lymphocyte Therapy in B-Cell NHL/CLL Refractory to Chemo	Relapsed from at least 2 prior treatments - the last less than 1 year; cd19 expressed on tumor	Engineered t-cells targeting cd19 (CAR19)	Can placing a gene into white blood cells may make the body build an immune response to kill cancer cells?	1, 6	4	Durable remission / cure? Reports
>	Hodgkin	Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma	relapsed DLBCL, MCL, or indolent NHL	Rituxan, Bendamustine, and btk inhibitor (PCI-32765)	What is the maximum tolerated dose of PCI-32765; what is the overall response rate?	6, 7	3	Curative intent or durable complete response? Reports
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Indolent (low grade) B-cell NHL  - mixed types				< Key Eligibility v Protocol / Agent	Study Question of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	indolent b-cell (FL, MZL, SLL)	TLR8 Agonist VTX-2337 in Combo With Local Radiation in Low-Grade B-cell Lymphomas	Relapsed from prior therapy; one site of disease  accessible for intratumoral injection	TLR8 Agonist (VTX-2337)	To determine the local and systemic anti-tumor effects of intratumoral injection of  TLR8 agonist, in combination with low-dose local radiation at a single tumor site	4, 5, 7	2	Management in refractory setting Reports
>	indolent b-cell NHL (FL, SLL, LPL, MZL)	Efficacy and Safety of CAL-101 in Patients With Indolent B-Cell NHL (DELTA)	Relapsed from at least 2 prior chemo- or immunotherapy-based regimens - refractory to Rituxan AND to alkylating agent (not transformed)	CAL101 - a oral agent that targets PI3k delta kinase	Activity and safety of study drug in relapsed and refractory indolent lymphoma; how long the oral study drug can be given to manage the condition?	7	3	Management in refractory setting Reports
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T-cell NHL  - mixed types				< Key Eligibility v Protocol / Agent	Study Question of Interest	Clinical Rationale?	Scientific Rationale 4 = highest	Goal of Therapy for Indication
>	cutaneous T-cell lymphoma (CTCL)	O6-Benzylguanine and Topical Carmustine in Early-Stage(IA-IIA) Cutaneous T-Cell Lymphoma	early stage ; failed at least one conventional treatment	O6-Benzylguanine and Topical Carmustine	To measure response rate and response time.	1, 6	4	Management in refractory setting Reports
>	t-cell NHL (PTCL, and other aggressive types)	SAHA + CHOP in Untreated T-cell Non-Hodgkin's Lymphoma	Newly diagnosed T-cell lymphoma (mixed type), systemic (not localized)	SAHA (Vorinostat) and CHOP	Activity and safety of study protocol in untreated t-cell lymphoma, which has a high relapse rate when treated with standard CHOP	6	2	Curative intent Reports
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					SEE ALSO Locate Trials by Type of Lymphoma & Treatment Status or by Type of Agent

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