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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

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

PROGRESS is a multimedia website designed to help prostate cancer survivors.

PROGRESS

Suzanne Miller, PhD

The purpose of this study is to test how well an online program designed to help prostate cancer survivors cope with changes caused by their cancer or treatment works compared to standard print educational materials from the National Cancer Institute (NCI).

This study involves the development and evaluation of a comprehensive and innovative multimedia program designed to facilitate the post-treatment transition into survivorship. The design of the intervention, the PRostate Cancer Online Guide and Resources for Electronic Survivorship Service (PROGRESS), is theoretically based on the team's Cognitive-Social Health Information Processing Model.

PROGRESS focuses on promoting adaptive coping within four key post-treatment domains: 1) Physical Dysfunction (e.g., physical symptoms); 2) Emotional Well- Being (e.g., fear of recurrence); 3) Interpersonal Concerns (e.g., sexual intimacy issues); and 4) Practical Barriers (e.g., medical follow-up challenges). Content for these domains are organized in a virtual resource center and will consist of: 1) provision of related information through text, graphics, voice overs, and animation; 2) videos of health care experts answering frequently asked questions; 3) videos of prostate cancer survivors describing their experiences and modeling competencies and coping strategies; and 4) skills training to improve communication between prostate cancer survivors and family and healthcare providers. Program content has been developed through literature and evidence-based content review, expert input, and input from multi-ethnic survivor focus groups. To ensure adequate and appropriate program content and optimal functionality, an iterative process of review, revision, and user and usability testing has been employed.

Intervention efficacy will be evaluated through a two-arm, prospective randomized controlled trial. A total of 600 patients (200 from Fox Chase Cancer Center, 200 from the Cancer Institute of New Jersey, and 200 from Icahn School of Medicine at Mount Sinai) will complete the study. Data will be collected at baseline, and at 1-, 3- and 6- months follow-up.

The primary outcome variable will be use of adaptive coping, and secondary outcome variables will include use of maladaptive coping, disease-specific quality of life, vitality/energy, physical quality of life, cancer-related intrusive thoughts, emotional quality of life, fear of recurrence, bother from physical dysfunctions, satisfaction with communication in medical interactions, satisfaction with cancer-related with family/friends, marital problems, and practical concerns . A theory-based test of mediators of intervention effects (i.e., self-efficacy for the survivorship phase, confidence in ability to manage symptoms related to prostate cancer, perceived information utility), and moderators (i.e., demographics, comorbid conditions, monitoring style, affect) will also be performed.

The proposed research will be the first Randomized Controlled Trial to evaluate a comprehensive and highly disseminable and self-sustaining intervention for facilitating post-treatment adaptation among early-stage Pca survivors. In addition, use of and usability, accessibility, and satisfaction with PROGRESS will be assessed.

Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)

Randomized Clinical Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors

Adaptive coping was measured with the Cancer Coping Questionnaire. The total score from the Cancer Coping Questionnaire is a mean scale. There were a total of 14 items, each with a Likert-type 4-point scale, with 1 being the minimum value and 4 being the maximum value. A higher score indicated greater coping ability (i.e., better outcome).

This will be measured using the Urinary Incontinence Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary incontinence (i.e., better outcome).

This will be measured using the Urinary Irritation Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had four items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less urinary irritation (i.e., better outcome).

This will be measured using the Bowel Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less bowel problems (i.e., better outcome).

This will be measured using the Sexual Functioning Scale from the Expanded Prostate Cancer Index Composite - Short Form (EPIC 26-SF), a 26 item shortened version of EPIC, a 61 item questionnaire for assessing urinary, bowel, sexual, and hormonal dysfunction and distress/bother in prostate cancer patients. The scale had six items, each with a Likert-type 4- or 5-item scale, with 1 being the minimum and 4 or 5 being the maximum. These scores were then recoded to a 0 to 100 scale, with higher scores indicating less sexual problems (i.e., better outcome).

Satisfaction with communication in medical interactions will be assessed with the medical interactions scale from the Cancer Rehabilitation Evaluation System (CARES): difficulty communicating with the medical team, and problems obtaining information from the medical team. The minimum value is 0 and the maximum value is 4. A higher score means patients had worse medical interactions (i.e., worse outcome).

Satisfaction with marital communication will be assessed from the marital problems scale from the Cancer Rehabilitation Evaluation System (CARES). The minimum value is 0 and the maximum value is 4. A higher score means more marital problems (i.e., worse outcome).

National Cancer Institute (NCI)

Fox Chase Cancer Center

No adverse events anticipated in low-risk behavioral trial.

Control

PROGRESS

PROGRESS: PROGRESS is a multimedia website designed to help prostate cancer survivors.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Trial of an Online Multimedia Program to Boost Coping & Function for Prostate Cancer Survivors (PROGRESS)	NCT02224482	Prostate Cancer	PROGRESS	18 Years - 80 Years	Fox Chase Cancer Center

Spots Global Cancer Trial Database for progress

Every month we try and update this database with for progress 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 progress

Every month we try and update this database with for progress 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 progress 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.