Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Patients who meet eligibility criteria will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study.

Lam Elaine, M.D

This study is aimed to determine the feasibility of obtaining and molecularly characterizing pre-treatment tumor biopsies, to determine the feasibility of obtaining and molecularly characterizing archival and post-treatment tumor biopsies, to assess molecular expression changes between archival and baseline tumor samples, and to assess molecular expression changes between tumor samples obtained at baseline and at the time of disease progression.

This study will be a companion study to existing phase I clinical trial treatment studies. It is being done to determine the feasibility of obtaining tumor tissue for genomic analysis. Patient will be offered enrollment into this trial at the time that they are being considered for participation in a phase I treatment trial. After consenting for this study, patients will undergo a fresh tumor biopsy and collection of research blood samples. Archived tumor specimens will also be obtained and analyzed. At the time of disease progression, fresh tumor biopsies and blood samples will be collected in patients who have evaluable pre-biopsy specimens and who are eligible to be screened for another study. This will be informative to evaluate the mechanisms of resistance to that agent.

Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy

Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy in Patients With Advanced Malignancies

As this is an exploratory, pilot feasibility study, data will be analyzed primarily with descriptive statistics. It is anticipated that this study will take up to 24-36 months to complete accrual of up to 50 patients.

The rate of obtaining adequate post-treatment tumor biopsies and blood samples for molecular characterization at the time of disease progression, the rate of complications, and the rate of successful molecular characterization will be calculated and analyzed with descriptive statistics.

University of Colorado, Denver

Heart and Blood Diseases

Immune System Diseases

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Lymphoma

Hodgkin Disease

Waldenstrom Macroglobulinemia

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphosarcoma

Hodgkin Lymphoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Proteasome Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 115.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

Carfilzomib

The purpose of this study is to test the safety and tolerability of carfilzomib at different dose levels on hematological cancers such as multiple myeloma, non-Hodgkin's lymphoma, Hodgkin's disease, or Waldenstrom's macroglobulinemia. Carfilzomib is a proteasome inhibitor, an enzyme responsible for degrading a wide variety of cellular proteins.

Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies

A Phase I Study of the Safety and Pharmacokinetics of Escalating Intravenous Doses of the Proteasome Inhibitor PR-171 in Patients With Hematological Malignancies

A DLT was defined as any of the following occurring in the first 28 days of study participation:

Nonhematologic:

* \> Grade 2 neuropathy with pain
* ≥ Grade 3 nonhematologic toxicity (excluding nausea, vomiting, or diarrhea)
* ≥ Grade 3 nausea, vomiting, or diarrhea uncontrolled by maximal antiemetic/antidiarrheal therapy

Hematologic:

* Grade 4 neutropenia (absolute neutrophil count \[ANC\] \< 0.5 × 10ˆ9/L) lasting ≥ 14 days without hematopoietic growth factor support
* Febrile neutropenia (ANC \< 1.0 × 10ˆ9/L with a fever ≥ 38.3°C)
* Grade 4 thrombocytopenia (platelets \< 25.0 × 10ˆ9/L) or thrombocytopenia associated with bleeding.

Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) of the National Cancer Institute (NCI) version 3.0.

Disease response criteria for NHL were according to the International Working Group Criteria for Non-Hodgkin's Lymphoma. Disease response criteria for Multiple Myeloma were according to the European Group for Blood and Marrow Transplantation (EBMT). Disease response criteria for WM were according to the consensus panel recommendations from the Second International Workshop on Waldenström's Macroglobulinemia. The disease response criteria for Hodgkin's Lymphoma are defined as follows:

* Complete response: total resolution of measurable disease parameters.
* Partial response: a ≥ 50% resolution without the appearance of new disease.
* Stable disease: between \< 50% resolution and ≤ 25% increases in measurable disease parameters without appearance of new disease.
* Progressive disease: an increase of \> 25% in measurable disease parameters.

Best clinical response is the best response observed from the start of study treatment until disease progression or death.

Duration of objective response is defined as the time from the date of first documented assessment of clinical response (confirmed or unconfirmed complete response, partial response, or minimal response) to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment.

Median duration of response was calculated using the Kaplan-Meier method.

Time to progressive disease is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease, plus one day. Participants without tumor progression were censored at the date of their last clinical response assessment.

Median time to progression was calculated using the Kaplan-Meier method.

Progression-free survival is defined as the time from the date of Cycle 1, Day 1 of treatment to the date of documented assessment of progressive disease or death, whichever comes first, plus one day. Participants without tumor progression or death were censored at the date of their last valid clinical response assessment. Median progression-free survival was calculated using the Kaplan-Meier method.

Amgen

Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.

CFZ 1.2 mg/m²

CFZ 2.4 mg/m²

CFZ 4.0 mg/m²

CFZ 6.0 mg/m²

CFZ 8.4 mg/m²

CFZ 11.0 mg/m²

Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.

CFZ 15.0 mg/m²

CFZ 20.0 mg/m²

CFZ 27.0 mg/m²

CFZ 20/27 mg/m²

CFZ 20/27 mg/m² + DEX

Total

Dose Escalation (Part 1)

Dose Expansion (Part 2)

Age, Continuous

Sex: Female, Male

African American

Caucasian

Hispanic

Native American

Race/Ethnicity, Customized

Non-Hodgkin's Lymphoma

Waldenstrom's Macroglobulinemia

Hodgkin's Disease

Disease Diagnosis

Study Director

Safety-evaluable: All participants who were enrolled and received at least 1 dose of carfilzomib

Number of Participants With Dose-limiting Toxicities (DLTs)

Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

CFZ 20/27 mg/m² (±DEX)

Participants with available pharmacokinetic (PK) data. Cmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Maximum Observed Plasma Concentration of Carfilzomib (Cmax)

Complete Response

Partial Response

Minimal Response

Stable Disease/No Change

Progressive Disease

Unknown

Biologic response-evaluable: All participants who received at least 1 cycle of carfilzomib and had both baseline and at least 1 post-baseline disease assessment.

Best Clinical Response to Treatment

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.

Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).

Biologic response-evaluable participants with an objective response

Duration of Response

Time to Progression

Progression-free Survival

Participants with available pharmacokinetic (PK) data. Tmax was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Time to Maximum Observed Plasma Concentration of Carfilzomib (Tmax)

Participants with available pharmacokinetic (PK) data. AUClast was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Area Under the Concentration-time Curve to Last Measureable Timepoint (AUClast) for Carfilzomib

Participants with available pharmacokinetic (PK) data. AUCinf was only determined for cohorts receiving carfilzomib ≥ 11 mg/m². For cohorts with carfilzomib dose at 1.2-8.4 mg/m², carfilzomib was measurable at too few time points to allow a good estimation. Participants in the two Dose Expansion cohorts (20/27 mg/m²) were combined for PK analyses.

Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf) for Carfilzomib

Overall Study

The patients will receive a individual dietary counseling based on the taste-test

The patients will receive a individual standard dietary counseling not based on the taste-test

Patients will receive a dietary counseling based on a simple taste-test

Taste-test

Patients will receive a dietary counseling based on a standard dietary counseling for the patient group

Standard care

The purpose of the study is to investigate whether a simple taste-test will increase the intake of energy as part of the individual dietary counseling.

The investigators will investigate the tastes (umami, bitter, salty, sweet and sour) that the patients prefers in order to increase the energy intake and reduce the risk of weight loss and loss of fat-free mass for patients with hematological cancer.

The study will be conducted as a single blinded randomized controlled trial. 40 patients will be recruited, and will be divided into two groups; the intervention group and the control group. The patients will not know which group they belong to.

Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy

Individuel diætvejledning på Baggrund af Smagstest Hos Patienter Med hæmatologisk Cancer i Cytostatisk Behandling

difference - before and after intervention

difference - before and after intervention. Higher scores means worse outcome. Lower scores means better outcomes.

difference - before and after intervention measured with Likert scale (1 to 5). Higher scores means a worse outcome. Lower scores means better outcomes.

Zealand University Hospital

University of Copenhagen

Symptoms and General Pathology

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Philadelphia Chromosome

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Vincristine

Tubulin Modulators

Antimitotic Agents

Eligible subjects received study drug at 2.25 mg/m\^2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Dosing was done every 7 days (± 3 days) on Days 1, 8, 15, and 22 with no less than 4 days between dosing days. Dose calculations were based on body surface area using the subject's height (from Screening) and actual weight for each course.

Marqibo® (vincristine sulfate liposomes injection)

Susan O'Brien, MD

This was a Phase 2, international, multicenter, open-label, single-arm trial evaluating Marqibo (VSLI) in adult subjects with: 1) Ph- ALL or lymphoblastic lymphoma in second or greater relapse; or 2) Ph- ALL or lymphoblastic lymphoma who failed 2 or greater treatment lines of anti-leukemia chemotherapy. The original enrollment target for this study was approximately 56 subjects. Per a protocol amendment, enrollment was increased from 56 to 65.

The primary objective of this study was to evaluate:

- The efficacy of the study treatment as determined by the rate of CR plus CR with incomplete blood count recovery (CRi) in adult subjects with Philadelphia chromosome-negative (Ph-) ALL in second relapse or adult subjects with (Ph-) ALL who failed 2 treatment lines of anti-leukemia chemotherapy. Subjects must have achieved a CR to at least 1 prior anti-leukemia therapy as defined by a leukemia-free interval of ≥ 90 days.

The secondary objectives of this study were to evaluate:

* Duration of CR plus CRi
* Overall survival
* Safety and tolerability

Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia

A Phase 2 Study to Evaluate the Safety and Efficacy of Weekly Doses of Marqibo® (Vincristine Sulfate Liposomes Injection) in Adult Patients With Philadelphia Chromosome-negative Acute Lymphoblastic Leukemia (ALL) in Second Relapse or Adult Patients With Philadelphia Chromosome-negative ALL Who Failed Two Treatment Lines of Anti-leukemia Chemotherapy

CR is defined as no evidence of ALL: ANC\>or=1x10\^9/L or platelet count\>100x10\^9/L, absence of leukemia blast cells in blood and marrow (\<5% blasts), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery (CRi): As per CR but platelet count\< 100x10\^9/L or ANC\< 1x10\^9/L. Partial remission(PR):CR with\>5-25% abnormal cells in the marrow or 50% decrease in bone marrow blasts. Reduction in EMD by at least 50%. Hematologic Improvement. Bone marrow blast(BMB) response: BMB\<5% in the absence of HI. Stable disease(SD):No significant hematological and extramedullary change from baseline.

Number of subjects who achieved Complete Remission (CR)as assessed by the IRRC. CR is defined as no evidence of ALL. ANC\>=1X10\^9/L or Platelet count\>=100x10\^9/L, absence of blasts in blood and morrow (\<5%), resolution of all sites of extramedullary disease (EMD). CR with incomplete blood count recovery(CRi)is defined as per CR but platelet count \<100x10\^9/L or ANC\<1x10\^9/L.

Duration of response for those subjects who achieved CR or CRi

Time, in days, from informed consent date until the date of death or date of last contact

Parexel

Spectrum Pharmaceuticals, Inc

Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).

Marqibo

Age, Categorical

United States

Canada

Israel

Germany

Region of Enrollment

Chief Medical Officer

Subjects who had CR plus CRi by the PI and the IRRC assessments using the International Working Group Criteria. The Intent-to-Treat Analysis, n=65, minimum 1 dose. The IRRC, n=53, 1 dose, assess response as determined by the IRRC. Analyses, a Simon's 2-stage minimax design where the type I error alpha was set at 0.10 and the power was 80%.

Complete Remission Plus Complete Remission Without Full Platelet Recovery (CR + CRi)

Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.

Eligible subjects received Marqibo at 2.25mg\^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)

Based on the first date of CR or CRi to the date of the last available histologic assessment of the same response (n=8)

Duration of CR + CRi

The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.

Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)

Based on the first date of CR or CRi to date of documented relapse, death, or subsequent chemotherapies including hematopoietic stem cell transplant (HSCT)(n=10)

Overall Survival

Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.

Eligible subjects received Marqibo at 2.25mg\^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)

The IRRC evaluable population included all subjects who received at least 1 dose of study drug and who has reviewable data to assess and determine response or lack of response as determined by the IRRC.

Clinical Response Assessment Per Independent Response Review Committee (IRRC) Evaluation

Behaviors and Mental Disorders

Fatigue

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Acute Disease

Disease Attributes

Quality of Life

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.

Health counseling and exercise

Mary Jarden, Ph.D.

The purpose of this pilot study is to test an exercise-based multidimensional intervention for patients with acute leukaemia undergoing consolidation chemotherapy in the context of outpatient management. Further, to test for safety, feasibility and preliminary effect on physical and functional capacity, and health related quality of life.

Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study

Patient Activation Through Counseling and Exercise - Acute Leukemia - Pilot Trial

Number of patients that withdrew from the project

Change in scores for quality of life/function

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study of Genomic Sequencing to Find Potential Targets for Personalized Therapy	NCT01869218	Hematologic Neo...		18 Years -	University of Colorado, Denver
Safety Study of the Proteasome Inhibitor PR-171 (Carfilzomib for Injection) in Patients With Hematological Malignancies	NCT00150462	Waldenstrom's M... Non-Hodgkin's L... Hodgkin's Disea... Multiple Myelom...	Carfilzomib Dexamethasone	18 Years -	Amgen
Individual Dietary Counseling Based on Taste-tests in Patients With Hematological Cancer in Cytostatic Therapy	NCT05364359	Hematological M...	Taste-test Standard care	-	University of Copenhagen
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia	NCT00495079	Acute Lymphobla...	Marqibo® (vincr...	18 Years -	Spectrum Pharmaceuticals, Inc
Safety and Efficacy of Marqibo in Relapsed Acute Lymphoblastic Leukemia	NCT00495079	Acute Lymphobla...	Marqibo® (vincr...	18 Years -	Spectrum Pharmaceuticals, Inc
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study	NCT01557686	Acute Leukemia	Health counseli...	18 Years -	Universitetshospitalernes Center for Sygepleje
A Study of Extended Carfilzomib Therapy for Patients Previously Enrolled in Carfilzomib Treatment Protocols	NCT00884312	Multiple Myelom... Solid Tumors	Carfilzomib	18 Years -	Amgen
Health Counseling and Exercise in Patients With Acute Leukemia - Pilot Study	NCT01557686	Acute Leukemia	Health counseli...	18 Years -	Universitetshospitalernes Center for Sygepleje
Study of the Safety and Pharmacokinetics of Carfilzomib in Patients With Relapsed and Refractory Multiple Myeloma and Varying Degrees of Renal Function	NCT00721734	Multiple Myelom... Renal Insuffici...	Carfilzomib	18 Years -	Amgen
Can Treatment With Bismuth Reduce Toxicity to Chemotherapy and Radiotherapy?	NCT00892502	Hematological D... Hematological M... Blood Diseases Malignant Lymph... Leukemia Multiple Myelom...	Bismuth tablets Placebo tablets	18 Years - 75 Years	Copenhagen University Hospital at Herlev
Liquid Biopsy Evaluation and Repository Development at Princess Margaret	NCT03702309	Cancer Breast Cancer Lung Cancer Colon Cancer Ovarian Cancer Melanoma Lymphoma Leukemia Mutation Lynch Syndrome Cowden Syndrome BRCA1 Mutation BRCA2 Mutation Uterine Cancer Myeloma Kidney Cancer Head and Neck C... Meningioma		18 Years -	University Health Network, Toronto

Spots Global Cancer Trial Database for hematological