Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Anti-Infective Agents

Gemcitabine

Paclitaxel

Albumin-Bound Paclitaxel

Azacitidine

Immunomodulating Agents

Durvalumab

Lenalidomide

Romidepsin

Tubulin Modulators

Antimitotic Agents

Antimetabolites

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Histone Deacetylase Inhibitors

Part 1a: Romidepsin (2 mg/m² or 3.3 mg/m² or 7 mg/m²) will be administered in combination with nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles.

Part 1a: Azacitidine (20 mg/m² or 30 mg/m² or 40 mg/m²) will be administered on Days -7 to Day -3 of each treatment cycle. Additionally nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be given on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles.

Part 1a: The intervention to be administered depends on the determined dose in Arm A and Arm B. Additionally nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be given on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle. Study treatment is given until intolerable toxicity or will escalate until the recommended dose for expansion for a maximum of 3 cycles.

nab-Paclitaxel (125 mg/m²)/Gemcitabine (1000 mg/m²) will be administered on Day 1, Day 8 and Day 15 (every 28 days) of each treatment cycle.

In Part 1b (expansion part) of the study, one of the treatment arms (Arm C over Arm B over Arm A) will be continued. Treatment will only be performed with the study drug that were tolerable in Part 1a (dose escalation).

Part 2: All patients from Part 1 who have not progressed after three cycles receive standard fixed dose Durvalumab (1500 mg) on Day 1 of each 28-day treatment cycle by IV infusion in combination with orally administered low-dose Lenalidomide (10 mg) on Days 1 to 21 until documented disease progression. Study treatment is given for a maximum of 13 cycles.

Powder and solvent for solution for infusion; Intravenous use

Powder for suspension for injection; Subcutaneous use

Powder for suspension for injection; Intravenous use

nab-Paclitaxel

Powder for solution for infusion; Intravenous use

Concentrate for solution for infusion; Intravenous use

Lenalidomide capsule

Jens Siveke, Prof. Dr.

A multi-center, open-label phase I/II study to to determine the safety and tolerability of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine in patients with advanced pancreatic ductal adenocarcinoma (PDAC) (Part 1), followed by sequential immune targeting with programmed death-ligand (PD-L)1 blockade in combination with low-dose Lenalidomide (Part 2) in patients with controlled disease after 3 cycles (Part 1).

The first part of the study will employ a standard 3 + 3 design to test safety and tolerability of histone deacetylase (HDAC) inhibition with Romidepsin (Arm A), DNA methyltransferase (DNMT) inhibition with Azacitidine (Arm B) or both agents (Arm C), in each arm in combination with nab-Paclitaxel/Gemcitabine (Part 1a). Study treatment is given until intolerable toxicity as defined in the protocol. Treatment will escalate until the recommended dose for RDE is identified.

For the expansion part (Part 1b) of the study, one of the treatment arms (Arm C over B over A) will be continued using a Simon Two-stage design to a maximum of 35 patients.

All patients from Part 1a and 1b will be treated for a total of three cycles and will then enter the second part of the study in case of disease control with still measurable disease (PR, SD).

In the second part (Part 2) of the study (consolidation therapy), all patients from Part 1 (dose escalation and expansion cohorts from experimental arms and standard arm) who have not progressed after three cycles of nab-Paclitaxel/Gemcitabine with or without additional epigenetic treatment (= at least SD by RECIST 1.1 after 3 cycles) receive sequential immune targeting with PD-L1 blockade (standard fixed dose Durvalumab 1500 mg q4w iv) in combination with low-dose Lenalidomide (10 mg d1-21 q4w po) until documented disease progression.

Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer

A Multicenter, Phase I/II Study of Sequential Epigenetic and Immune Targeting in Combination With Nab-Paclitaxel/Gemcitabine in Patients With Advanced Pancreatic Ductal Adenocarcinoma.

Dose limiting toxicities occurring during treatment cycle 1 of a respective dose level and regarded to be related to the studied drug combination. Common terminology criteria for adverse events (CTCAE) 5.0 will be used to assess toxicities.

The efficacy and safety of this experimental (immune) consolidation therapy during this clinical trial will be monitored by imaging changes every 8 weeks.

The efficacy and safety of this experimental (immune) consolidation therapy during this clinical trial will be monitored closely by tumor marker changes on Day 1 of each cycle.

Identification of the recommended dose for expansion of Azacitidine and/or Romidepsin in combination with nab-Paclitaxel/Gemcitabine.

Part 1: ORR according to RECIST version 1.1 (complete response \[CR\] and partial response \[PR\]) after respective treatment) every 6 weeks Part 2: ORR according to immune related RECIST 1.1 (irRECIST1.1) (CR and PR) after/during treatment with Lenalidomide and Durvalumab every 8 weeks

Part 1: CA19-9 Response: CA19 -9 change after treatment compared to baseline level Part 2: 2nd CA19-9 Response: CA19 -9 change after treatment compared to last level determined in Part 1

Part 1: DCR at 3-month according to RECIST version 1.1 (CR and PR and stable disease \[SD\] after respective treatment Part 2: 2nd DCR at 3-month and 6-month according to irRECIST1.1 (CR and PR and stable disease \[SD\] after respective treatment)

Time from Day 1 of the first cycle of chemotherapy to date of death from any cause. The rate of patients who are still alive after one year will be assessed.

Time from Day 1 of the first cycle of chemotherapy to date of objective disease progression or to death of any cause.

Celgene

AstraZeneca

GWT-TUD GmbH

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Daratumumab

Dexamethasone acetate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

A continuous therapy arm - continuation of therapy with Dara-Rd until PD

treatment free interval arm - discontinuation of therapy with Dara-Rd, which will be resumed at biochemical progression and given until PD

Patients who have been treated with 12 cycles of Daratumumab-Lenalidomide-Dexamethasone (Dara-Rd) will be randomized between Arm A (continuous therapy) and Arm B (treatment free interval)

Daratumumab Injection

Sonja Zweegman, Prof Dr MD

Maarten Seefat, MD

In the Netherlands, the standard treatment for multiple myeloma is a combination of different medicines named daratumumab-lenalidomide-dexamethasone, abbreviated as Dara-Rd. In many patients this treatment results in suppressing the disease for a long time. The treatment is continued until it is not effective anymore and the disease progresses.

But until now it is unknown whether continuous therapy also leads to prolonging life. In addition, there are concerns about side effects, leading to a reduced quality of life, the development of severe toxicity that remains, which hampers subsequent therapy, and high costs due to prolonged treatment.

There are indications that temporarily stopping treatment is safe, leading to fewer side effects and allows recovering from toxicity or damage due to treatment. This may improve the quality of life.

FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)

FeAsiBility of a Treatment Free Interval in Newly Diagnosed mUltiple myeLOma Patients Treated With DaratumUmab-Lenalidomide-DexamethaSone- the FABULOUS Study. A Nationwide Open-label Randomized Phase III Clinical Trial Comparing Daratumumab-lenalidomide-dexamethasone Continuously Versus Including a Treatment Free Interval

To compare Event-Free Survival (EFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD

To compare Progression Free Survival (PFS) from the time of randomization, between arm A continuous therapy with Dara-Rd until PD versus arm B discontinuation of therapy with Dara-Rd, resuming therapy at the first signs of biochemical progression until PD

To compare adverse event (AE) burden between arms

To compare PROMs between arms via validated questionnaires such as Impact of Cancer version 2 Cancer Worry scale

To compare cost-effectiveness between arms

To determine the length of the treatment-free interval (TFI) in arm B

To determine time to (maximal) response after restart of Dara-Rd in arm B.

To compare time to next treatment (TTNT) between arms

To compare time from randomization to progression on second-line therapy (PFS2) between arms.

To compare Overall Survival (OS) between arms.

To compare the discontinuation rate and the reasons for discontinuation between arms.

To evaluate cumulative dose of daratumumab, lenalidomide and dexamethasone in both arms.

To compare dose reductions of daratumumab, lenalidomide and dexamethasone between arms.

To compare toxicity according to CTCAE v5 between arms

To compare Quality of Life between arms via validated questionnaires such as QLQ-C30, MY20, EQ-5D-5L

To compare relative dose intensity (RDI) of daratumumab, lenalidomide and dexamethasone between arms.

Stichting Hemato-Oncologie voor Volwassenen Nederland

Lymphoma

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Lymphatic Diseases

B-cell Lymphoma

Lymphosarcoma

In this study, lenalidomide was administered at a fixed dose, in which 25 mg was used for DLBCL patients,and 20mg was used for other B-NHL patients such as FL, MZL, MCL, etc. and daily oral therapy with IMM0306 was used on the 1\~21st day of each repeat 28-day cycle.

The RP2D of the IMM0306 monotherapy trial was administered once a week (7 days ± 1 day) for intravenous infusion every 4 weeks

IMM0306 is a fusion protein of CD20 mAb with the CD47 binding domain of SIRPα. The Fc segment of the recombinant protein in IMM0306 is IgG1 and has been modified by ADCC-enhanced genetic engineering.

IMM0306

Chemical name 3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidin-2,6-dione, molecular formula C 13H 13 N 3 O 3, is an anti-tumor drug developed by Celgene Biopharmaceutical Company in the United States, with multiple effects such as anti-tumor, immunomodulatory and anti-angiogenesis

jinhua zhou

The objective of this study was to evaluate the safety and efficacy of IMM0306 in combination with lenalidomide in patients with relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma.

Main study purpose:

To assess the safety and tolerability of IMM0306 in combination with lenalidomide to determine the maximum tolerated dose (MTD) (if available) and the recommended Phase 2 dose (RP2D).

Secondary study purpose

1. To assess the antitumor efficacy of IMM0306 in combination with lenalidomide.
2. To assess the immunogenicity of IMM0306 in combination with lenalidomide.
3. To evaluate the pharmacokinetic (PK) profile of IMM0306 in combination with lenalidomide.

Exploratory study purpose:

1. Explore the correlation between exposure to IMM0306 and efficacy and safety (data permitting).
2. Explore the correlation of biomarkers with safety.

A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide

A Phase Ib/IIa Clinical Study of IMM0306 fo r Injection in Combination With Lenalidomide for the Treatment of Relapsed/Refractory CD20-Positive B-Cell Non-Hodgkin's Lymphoma Cell Non-Hodgkin's Lymphoma

To be summarized using descriptive statistics

If the planned dose escalation of IMM0306 in combination with lenalidomide to a preset highest dose group (i.e., the single-agent RP2D dose recommended in the IMM0306-I trial) does not reach MTD, it will be possible to continue to increase the dose exploration or explore new frequency of administration. SMC will also review pre-safety data and recommend whether to further increase the dose and explore new dosing frequencies.

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Bortezomib

Alternating cycles of:

Selinexor oral 40mg once weekly Lenalidomide oral 25mg d 1-21 Dexamethasone 20mg d 1+2, 8+9 and 15+16 i 28 days cycles and Selinexor oral 80mg once weekly Bortezomib sc 1.3mg/sqm once weekly Dexamethasone 20mg d 1+2, 8+9 and 15+16 in 28 days cycles for up to 16 cycles (8 of each, alternating) followed by continuos selinexor 40mg(once weekly)-lenalidomide-dexamethasone

for up to 16 cycles followed by continuos lenalidomide-dexamethasone

Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone

Selinexor 20 MG Oral Tablet

Bortezomib Injection

Dexamethasone Oral

Ida B Kristensen, MB

Hanne Norseth, MD

An unrandomized phase 2 study of selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed, transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up within the Nordic Multiple Myeloma Study Group

An unrandomized phase 2 study evaluating selinexor in combination with lenalidomide/ bortezomib and dexamethasone to newly diagnosed transplant in-eligible symptomatic multiple myeloma patients in a multicenter international set-up with in the Nordic Multiple Myeloma Study Group.

The study will include 50 patients, recruited within the NMSG collaborating countries. After induction patient will be treated with continued lenalidomide-dexamethasone according to SWOG, with continuous 40mg selinexor weekly in the selinexor arm (experimental arm B).

Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients

Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in Transplant Ineligible Newly Diagnosed Multiple Myeloma Patients (SABLe): An Investigator Sponsored Trial

ORR at end of induction, with response defined according to IMWG response criteria

MRD negativity by NGS at end of induction

Time to at least PR from start of treatment

Comparison of toxicity rates according to NCI-CTCAE v4.03

Time to at least VGPR from start of treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer	NCT04257448	Pancreas Cancer Pancreatic Aden... Pancreatic Duct...	Romidepsin Azacitidine nab-Paclitaxel Gemcitabine Durvalumab Lenalidomide ca...	18 Years -	GWT-TUD GmbH
Safety and Tolerance of Epigenetic and Immunomodulating Drugs Combined With Chemotherapeutics in Patients Suffering From Advanced Pancreatic Cancer	NCT04257448	Pancreas Cancer Pancreatic Aden... Pancreatic Duct...	Romidepsin Azacitidine nab-Paclitaxel Gemcitabine Durvalumab Lenalidomide ca...	18 Years -	GWT-TUD GmbH
FeAsiBility of a Treatment Free Interval in Newly Diagnosed MM Patients Treated With Daratumumab-lenalidomide-dexamethasone (HOVON174MM)	NCT06187441	Multiple Myelom...	Daratumumab Inj... Dexamethasone Lenalidomide ca...	18 Years -	Stichting Hemato-Oncologie voor Volwassenen Nederland
A Clinical Study of Injectable IMM0306 in Combination With Lenalidomide	NCT05771883	B-cell Non-Hodg...	IMM0306 Lenalidomide ca...	18 Years -	ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Selinexor With Alternating Bortezomib or Lenalidomide Plus Dexamethasone in TIE Newly Diagnosed MM Patients	NCT04717700	Multiple Myelom...	Selinexor 20 MG... Bortezomib Inje... Lenalidomide ca... Dexamethasone O...	18 Years -	Odense University Hospital

Spots Global Cancer Trial Database for lenalidomide capsule