Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Behaviors and Mental Disorders

Infections

Nervous System Diseases

Rare Diseases

Recurrence

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Mantle-Cell

Lymphoma, Follicular

Lymphoma, B-Cell, Marginal Zone

Lymphoma, B-Cell

Aggression

Burkitt Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Mantle Cell Lymphoma

Follicular Lymphoma

Marginal Zone Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Anti-Infective Agents

Antirheumatic Agents

Carboplatin

Dexamethasone

Cytarabine

Rituximab

Cisplatin

Immunomodulating Agents

Lenograstim

Lenalidomide

Dexamethasone acetate

Antineoplastic Agents, Immunological

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Angiogenesis Inhibitors

Growth Inhibitors

Combination treatment with immunochemotherapy (R-DHAP) and lenalidomide

Dosage:

Rituximab 375 mg/m² day 1, i.v. Cisplatin 100 mg/m² or Carboplatin AUC5 day 2, i.v. Cytarabine 2000 mg/m², administered twice, on day 3, i.v. Dexamethasone 40 mg, days 2-5, p.o. Lenalidomide 5-20 mg, day 1-7 / day-6-+7, p.o. PEG-Filgrastim 6 mg, day 6, s.c.

peripheral stem cell collection after cycle 1 or 2

Cytarabine 2000 mg/m², administered twice

5-20 mg administered either d1-d7, or d-6-d7

PegFilgrastim

collection of peripheral stem cells for autologous stem cell transplantation

peripheral stem cell collection

Bertram Glaß, MD

The goal of this study is to evaluate efficacy and safety of the combination of lenalidomide, an immunomodulatory drug (IMiD) with a standard immunochemotherapy treatment, called R-DHAP. R-DHAP consists of a monoclonal antibody called Rituximab and chemotherapy consisting of Dexamethasone, high dose Cytarabine, often called Ara-C, and platinum based chemotherapy, either cisplatinum, or, if treatment with cisplatinum is contraindicated, carboplatinum.

This is a phase 1/2 study to evaluate the efficacy and safety of lenalidomide added to a standard chemotherapy regime of R-DHAP (Rituximab, Dexamethasone, high-dose Cytarabine, Cis/Carboplatinum) in the treatment of relapsed or refractory high-grade B-cell non-hodgkin-lymphoma (NHL).

The study hypothesis is that the combination of lenalidomide with standard immunochemotherapy will lead to an overall response rate of at least 60%. In this study, 3 rounds of immunochemotherapy in combination with lenalidomide will be administered. After the first or second round of therapy, peripheral hematopoetic stem cells will be harvested. Consolidation treatment with autologous or allogenic peripheral blood stem cell transplantation is recommended in all patients suitable, but is not part of the study.

In phase 1, up to six cohorts of at least 6 patients each will be treated with the study therapy, with lenalidomide in increasing dosages, to determine the maximum tolerated dose (MTD).

In phase 2, 50 patients will be treated with the MTD. Efficacy and safety will be evaluated.

Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP

Open-label, Multicenter Phase I/II Study: Salvage Therapy of Progressive and Relapsed Aggressive Non-Hodgkin-Lymphoma by Combination of Lenalidomide (Revlimid®) With Rituximab, Dexamethason, High-dose ARA-C and Cisplatinum (R²-DHAP)

The percentage of patients which showed either a partial remission (PR), a complete remission with remaining uncertainty (CRu) or a complete remission (CR) after study treatment.

The maximum dose of lenalidomide tolerated with acceptable toxicity during phase 1 of this study. The MTD established in phase 1 of this study will be administered to 50 patients in phase 2 of this study.

The rate of patients which show progressive disease (PD) during or directly after study therapy

The collection of peripheral stem cells is needed to be able to offer the patient high dose chemotherapy followed by autologous stem cell transplantation after the study treatment has ended.

Stem cell collection of \<2.0 \*10e6 CD34+cells/kg will be considered insufficient.

laboratory WBC \< 1.0 /nl or Plt \< 25 /nl

Celgene

Amgen

Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH

Sarcoma, Kaposi

Castleman Disease

Lymphoma, Primary Effusion

Kaposi Sarcoma

Unicentric Castleman Disease

Multicentric Castleman Disease

Primary Effusion Lymphoma

Etoposide

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Vincristine

Pomalidomide

Etoposide phosphate

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

Treatment na(SqrRoot) ve large cell lymphoma arising in KSHV-MCD

Part A: 5 mg po daily for 21 days (full course) Part A: 5 mg po daily for 4 days (short course) Part B: 5 mg po daily for 5 days (Phase I/II dose) Part C: Phase I/II dose) po daily Day 1-21 of 28 day cycle for up to 12 cycles.

Part A: 375 mg/m2 day 22 (full course) Part A: 375 mg/m2 day 5 (short course) Part A: 375 mg/m2 day 1 (omit pomalidomode) Part B: 375 mg/m2 day 1

Part B: 60 mg/m2/day po x 5 days (day 1-5

Part B: 50 mg/m2/day CIVI over 24 hrs x 4 days

Part B: 10 mg/m2/day CIVI over 24 hrs x 4 days

Part B: 0.4 mg/m2/day CIVI over 24 hrs x 4 days

Thomas S Uldrick, M.D.

Background:

- The chemotherapy combination DA-EPOCH-RP includes the drugs etoposide (E), prednisone (P), vincristine (O), cyclophosphamide (C), doxorubicin (H), rituximab (R), and pomalidomide (P). Researchers want to see if including pomalidomide will help people with two rare lymphomas.

Objectives:

- To study the safety and efficacy of the chemotherapy drugs DA-EPOCH-RP.

Eligibility:

- Adults at least 18 years old. They must have primary effusion lymphoma or large cell lymphoma arising from Kaposi sarcoma Herpesvirus-associated multicentric Castleman disease.

Design:

* Participants will be with screened with blood tests, scans, spinal tap, and bone marrow sample. They may have skin or lymph node samples taken and fluid removed from around some organs.
* Participants will have breathing and eye tests. A camera may take pictures inside their body.
* Participants will take pomalidomide alone by mouth for up to 21 days. Then they will get rituximab by intravenous (IV) catheter, which is a small tube that goes into a vein..
* Participants will have an IV inserted in an arm or chest vein to get the IV chemotherapy drugs, at the same time the will take pomalidomide by mouth for 5 days.
* They will get DA-EPOCH-RP in 21-day cycles. Most people will have 6 cycles.
* They will get 4 study drugs by IV for 5 days and 2 others by mouth for 5 days.
* They will get daily filgrastim injections in the skin until white blood counts are acceptable
* For 2 days of some cycles, methotrexate will be injected into the spinal fluid.
* After completing EPOCH-RP, some participants who have Kaposi sarcoma will be prescribed pomalidomide for 3-weeks, followed by a one week break, for up to 12 months.
* Participants will repeat the blood tests often. They will also have repeated medical history, physical exam, urine and stool tests, and pictures of any rashes associated with these lymphomas.
* Participants will have several follow-up visits over 4 years.

Background:

* Kaposi sarcoma herpesvirus (KSHV)-associated primary effusion lymphoma (PEL) and large cell lymphoma arising from KSHV-MCD are aggressive B cell neoplasms with clinicopathologic and molecular profiles distinct from other AIDS-related lymphomas.
* There are no prospective studies on these rare lymphomas. Clinical experience is limited; however, reported prognosis is poor, with median survival estimated at less than 6 months using conventional CHOP-like chemotherapy.
* Novel treatment is urgently needed for KSHV-associated lymphomas, and the therapeutic approach must take into account concurrent KSHV-associated malignancies which are commonly seen in this patient population
* Pomalidomide, an immune-modulatory derivative (IMiD) of thalidomide has in vitro

direct antitumor effect in KSHV-lymphomas as well as immune modulatory and antiangiogenic effects that may be beneficial in treating both KSHV-NHL and in many patients, concurrent KS.

* Rituximab, an anti-CD20 monoclonal antibody, has recently been shown to be an active agent in the management of KSHV-MCD. Although PEL is a CD20-negative tumor, advances in the understanding the biology of KSHV-infection of B-cells, the pathobiology of IL-6 syndromes in KSHV-MCD and KSHV-NHL, and clinical experience using rituximab in the treatment of KSHV-MCD support use of rituximab in the treatment of KSHV-NHL, especially in patients with concurrent KSHV-MCD.
* Modified dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA)-EPOCH is an anthracycline-based regimen that allows for personalization of dose-intensity showing that inclusion of etoposide and infusional administration decreases tumor cell resistance.
* The use of DA-EPOCH in combination with rituximab for the treatment of HIVassociated diffuse large B-cell lymphoma or Burkitt lymphoma has been shown to be safe and effective.
* Given the central role of controlling HIV viremia with combination antiretroviral therapy (cART) in the management of KSHV-associated malignancies, as well as the likely contribution of uncontrolled HIV viremia to PEL pathogenesis, cART will be employed as an important part of the treatment regimen.

Objectives:

Phase I:

-Determine the maximum tolerated dose and/or recommended phase II dose of pomalidomide in combination with DA-EPOCH-R.

Phase II

-Evaluate overall survival in treatment-naive patients with primary effusion lymphoma treated with pomalidomide in combination with, DA-EPOCH and rituximab (DAEPOCH- RP).

Eligibility:

-Adult patients greater than or equal to 18 years with pathology confirmed primary effusion lymphoma,

including extracavitary variant OR large cell lymphoma arising in the setting of KSHVassociated MCD.

* Lymphoma that is measurable or assessable
* Previously treated patients will be allowed if they have not been treated with modified DA-EPOCH or pomalidomide for KSHV-associated lymphoma
* Any HIV status
* Hematologic and biochemical parameters within pre-specified limits at baseline
* Willing to use effective birth control, as defined in the full protocol
* Neither pregnant nor breast feeding
* Excluded if other serious co-morbid condition that would prohibit administration of planned chemotherapeutic intervention is present

Design:

* This is a phase I/ II study of pomalidomide in combination with modified DA-EPOCH-R in patients with PEL and diffuse large cell lymphoma arising in the setting of KSHVMCD.
* Phase I of the study will evaluate escalating doses of pomalidomide (3 mg, 4 mg, and 5 mg) in combination with modified DA-EPOCH-R to determine safe and tolerable phase II pomalidomide dose for combination.
* Treatment in both Phase I and Phase II will have three parts. Patients will receive up to 21 days of pomalidomide monotherapy (part A), followed by 6 cycles of pomalidomide in combination with modified DA-EPOCH-R (part B), and then an optional up to 12 months of pomalidomide (part C) for patients with concurrent KS, symptomatic KSHVMCD, or KSHV inflammatory cytokine syndrome (KICS).
* Patients with HIV will generally be prescribed cART.
* In phase I, with 3 dose levels, 9-18 patients will be accrued (3-6 patients per level).
* In the phase II portion of the study, 15 evaluable patients will be enrolled over 48-60 months and 12 months follow-up after the last patient has enrolled, a 1-tailed 0.10 alpha level test would have 80% power to determine if OS curve would demonstrate a 1-year OS consistent with 45% or better and ruling out 20% or worse.

Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas

Phase I/II Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas (Primary Effusion Lymphoma and Large Cell Lymphoma Arising in KSHV-Associated Multicentric Castleman Disease)

National Cancer Institute (NCI)

Glioma

Glioblastoma

Gliosarcoma

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Given orally once a day for 21 days followed by a 1 week rest period. Subject may continue to receive study drug as long as the disease does not worsen and they experience serious side effects

lenalidomide

Starting 4-7 days after the start of lenalidomide and given once a day, 5 days a week for 6-7 weeks

Radiation

Patrick Y. Wen, MD

- The purpose of this study is to find out if the combination of lenalidomide and radiation therapy is effective in controlling tumor growth in patients with newly-diagnosed supratentorial glioblastoma or gliosarcoma.

* Patients will receive lenalidomide orally once daily for 21 days followed by a one week rest period (this is equivalent to one cycle).
* Four to seven days from the first dose of lenalidomide, the patient will start radiation therapy for approximately 6-7 weeks.
* A neurologic exam and routine blood tests will be performed weekly while the patient is receiving radiation therapy.
* Following the 11th week of treatment a MRI/CT scan will be performed to assess the status of the tumor. If there is no change, or there is shrinkage in the size of the tumor, the treatment will continue for another 4 week cycle.
* The four week cycle will continue as long as the disease remains stable or improved and the patient does not develop intolerable side effects. A MRI/CT scan will be done every 2 cycles (8 weeks).

Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme

Phase II Study of Lenalidomide and Radiation Therapy in Patients With Newly Diagnosed Glioblastoma Multiforme.

Celgene Corporation

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Massachusetts General Hospital

University of Virginia

Dana-Farber Cancer Institute

Patrick Wen, MD

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Antipyretics

Analgesics

Anti-Allergic Agents

Central Nervous System Depressants

Dermatologic Agents

Respiratory System Agents

Thalidomide

Antibodies

Antibodies, Monoclonal

Acetaminophen

Melphalan

Bortezomib

Daratumumab

Immunoglobulins

Diphenhydramine

Promethazine

Montelukast

Analgesics, Non-Narcotic

Anti-Asthmatic Agents

Leukotriene Antagonists

Hypnotics and Sedatives

Anesthetics

Anesthetics, Local

Histamine H1 Antagonists

Histamine

Histamine phosphate

Histamine Antagonists

Neurotransmitter Agents

Daratumumab will be administered with Velcade-dexamethasone (VD).

Daratumumab will be administered with Velcade-melphalan-prednisone (VMP).

Daratumumab will be administered with Velcade-thalidomide-dexamethasone (VTD).

Daratumumab will be administered with pomalidomide-dexamethasone (Pom-dex).

Daratumumab will be administered with carfilzomib (CFZ)-dexamethasone (CFZ-dex) regimen.

Daratumumab will be administered with carfilzomib- lenalidomide-dexamethasone (KRd) regimen.

Administered by either intravenous or subcutaneous infusions, in combination with the applicable backbone treatment.

Administered subcutaneously in accordance with product labeling and local standards.

Velcade

Administered orally in accordance with product labeling and local standards.

Administered intravenously or orally in accordance with product labeling and local standards.

Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.

Administered in prophylactic doses by mouth in accordance with product labeling and local standards.

Administered intravenously in accordance with product labeling and local standards.

Carfilzomib

Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.

Janssen Research & Development, LLC Clinical Trial

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Therapy of Non-Hodgkin-Lymphoma by Combination of Lenalidomide + Rituximab, Dexa, High-dose ARA-C and CisP	NCT02983097	Diffuse Large B... Follicular Lymp... Mantle Cell Lym... Burkitt Lymphom... Aggressive Marg...	Rituximab Cisplatin Carboplatin Dexamethasone Cytarabine Lenalidomide PegFilgrastim peripheral stem...	18 Years - 70 Years	Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH
Study of Pomalidomide Combined With Modified DA-EPOCH and Rituximab in KSHV-Associated Lymphomas	NCT02228512	Large Cell Lymp... Primary Effusio...	Pomalidomide Rituximab Prednisone Etoposide Doxorubicin Vincristine Cyclophosphamid...	18 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Study of Lenalidomide and XRT in Patients With Newly Diagnosed Glioblastoma Multiforme	NCT00165477	Glioblastoma Gliosarcoma Malignant Gliom...	lenalidomide Radiation	18 Years -	Dana-Farber Cancer Institute
A Study of JNJ-54767414 (HuMax CD38) (Anti-CD38 Monoclonal Antibody) in Combination With Backbone Treatments for the Treatment of Patients With Multiple Myeloma	NCT01998971	Multiple Myelom...	Daratumumab Velcade Pomalidomide Dexamethasone Melphalan Prednisone Thalidomide Diphenhydramine Acetaminophen Carfilzomib Lenalidomide Montelukast	18 Years -	Janssen Research & Development, LLC
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors	NCT05511844	HER2-positive B... HER-2 Protein O... HER-2 Gene Ampl... HER2 Gene Mutat...	ORM-5029	18 Years -	Orum Therapeutics USA, Inc.
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors	NCT05511844	HER2-positive B... HER-2 Protein O... HER-2 Gene Ampl... HER2 Gene Mutat...	ORM-5029	18 Years -	Orum Therapeutics USA, Inc.
A Study of NX-2127 in Adults With Relapsed/Refractory B-cell Malignancies	NCT04830137	Chronic Lymphoc... Small Lymphocyt... Waldenstrom Mac... Mantle Cell Lym... Marginal Zone L... Follicular Lymp... Diffuse Large B... Primary Central...	NX-2127	18 Years -	Nurix Therapeutics, Inc.
Lenalidomide-Adriamycin-Dexamethasone (RAD) Induction Followed by Stem Cell Transplant in Newly Diagnosed Multiple Myeloma	NCT00925821	Multiple Myelom...	allogeneic stem... RAD	18 Years - 65 Years	Wuerzburg University Hospital

Spots Global Cancer Trial Database for imid

Every month we try and update this database with for imid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for imid

Every month we try and update this database with for imid cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for imid cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.