Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Syndrome

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Neoplasms

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Myelodysplastic Syndromes

Hematologic Diseases

Lymphoma

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

Bone Marrow Diseases

Lymphatic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Lymphosarcoma

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Anesthetics

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Melphalan

Busulfan

Thiotepa

Clofarabine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antimetabolites

Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)

Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)

Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)

Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)

total body irradiation

60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).

0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)

(CliniMACS) T-cell depleted PBSC Transplant

Richard O'Reilly, MD

The purpose of this study is to find out the effects of using a system called CliniMACS to remove Tcells from blood stem cells. Removing T-cells may help stop a side effect called Graft-Versus-Host Disease (GVHD). Some studies have been done with CliniMACS, but the Food and Drug Administration (FDA) has not yet approved it.

HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies

A Phase II Trial of Transplants From HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies and Other Lethal Hematologic Disorders

Standard BMT-CTN and IBMTR systems clinical criteria as defined by Rowlings, et al will be used to establish and grade acute GvHD. Chronic GvHD will be diagnosed and graded according to the criteria of Sullivan (CIBMTR).

Memorial Sloan Kettering Cancer Center

Please note: participants were not censored from adverse event evaluation if they had a second or third transplant on protocol

Hyperfractionated total body irradiation to a dose of 1375-1500 cGy (depending on age, stage of disease and requirement of general anesthesia) with lung shielding) Thiotepa (5 mg/kg/day x 2 or 10 mg/kg/day x 1) Cyclophosphamide (60 mg/kg/day x 2) (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated)

total body irradiation: dose of 1375-1500 cGy

Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1

Cyclophosphamide: 60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).

(CliniMACS) T-cell depleted PBSC Transplant

Total Body Irradiation, Thiotepa and Cyclophosphamide

Busulfan (0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified according to pharmacokinetics Melphalan (70mg/m2/day x 2 ) Fludarabine (25mg/m2/ day x 5)

Busulfan: 0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics

Melphalan: 70mg/m2/day x 2

Fludarabine: 25mg/m2/ day x 5

(CliniMACS) T-cell depleted PBSC Transplant

Busulfan, Melphalan and Fludarabine

Clofarabine (20mg/m2/ day x 5) (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval), Melphalan (70 mg/m2/day x 2) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)

Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1

Melphalan: 70mg/m2/day x 2

Clofarabine: 20mg/m2/ day x 5 (or, for children \<18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)

(CliniMACS) T-cell depleted PBSC Transplant

Clofarabine, Melphalan and Thiotepa

Melphalan (70 mg/m2/day x 2) Fludarabine (25mg/m2/ day x 5 ) Thiotepa (5 mg/kg/day x 2 or 10mg/kg/day x1)

Thiotepa: 5 mg/kg/day x 2 or 10 mg/kg/day x 1

Melphalan: 70mg/m2/day x 2

(CliniMACS) T-cell depleted PBSC Transplant

Melphalan, Fludarabine and Thiotepa

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Engrafted

Primary Graft Failure

Late graft failure

Not Evaluable Engraftment

Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.

The Incidence of Durable Hematopoietic Engraftment for T-cell Depleted Transplants Fractionated by the CliniMACS System Administered After Each of the Four Disease Targeted Cytoreduction Regimens.

aGVHD II-IV

cGVHD, Limited

cGVHD, Extensive

Number of Participants With Acute and Chronic GVHD Following T-cell Depleted, CD34+ Progenitor Cell Enriched Transplants Fractionated by the CliniMACS System.

Alive

Dead (not non-relapse mortality)

Dead (non-relapse mortality)

Incidence of Non-relapse Mortality (Transplant-related Mortality) Following Each Cytoreduction Regimen and a Transplant Fractionated by the CliniMACS System.

Survival

Disease Free Survival

2 patients received 2 separate transplants on each Arm A and C

Survival and Disease-free Survival (DFS)

Disease free survival

2 patients received 2 separate transplants on each Arm A and C. Please note 13 participants were not evaluated in the data set as they received a second or third HCT on protocol.

Proportion of Patients Receiving Optimal CD3+ (<1x10^5/kg) Cell Doses the Proportion of Patients Receiving CD3+ T-cell Doses > 1x10^5/kg.

Proportion of Patients Receiving Optimal CD34+ (> 5x10^6/kg) Cell Doses the Proportion Recurring Suboptimal Doses (< 2x10^6/kg) CD34+ Cells

Correlation of Doses of CD34+ Progenitors and CD3+ T Cells With Engraftment

Overall Study

Sarcoma

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Abexinostat

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Histone Deacetylase Inhibitors

PCI-24781 in combination with doxorubicin without mandated GCSF

PCI-24781 in combination with doxorubicin with mandated GCSF

Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

PCI-24781

Administered intravenously on Day 4 of each 3 week cycle

Administered on Day 5 of each 3 weeks cycle in Arm 1 if determined to be clinically indicated, and in all patients enrolled into Arm 2

GCSF

Edwin Choy, MD, PhD

The purpose of this research study is to determine the safety and maximum tolerated dose of PCI-24781 that can be given safely with doxorubicin (phase I) and the safety and efficacy of PCI-24781 when used in combination with doxorubicin (phase II) in patients with advanced sarcomas. The study drug, PCI-24781, is believed to regulate genes involved in tumor cell growth. The other study drug, doxorubicin, is considered a standard chemotherapeutic treatment for advanced sarcoma patients. We hypothesize that combining PCI-24781 with doxorubicin can overcome chemoresistance to doxorubicin.

* In the phase I portion of the study, since we are looking for the highest dose of PCI-24781 that can be administered safely without severe or unmanageable side effects in participants that have advanced sarcoma, not everyone who participates in this research study will receive the same dose of PCI-24871.
* Each treatment cycle is 3 weeks (21 days). Participants will take capsules of PCI-24871 for five consecutive days starting on Day 1 of each 3 week cycle. On Day 4 of each cycle, participants will come to the clinic to receive doxorubicin intravenously.
* At specific time intervals, participants will return to the clinic for the following tests and procedures: physical examination, vital signs, blood tests, urine test, EKG, assessment of the tumor by CT scan, and an ECHO or MUGA.
* Participants may remain on the study for a maximum of 6 cycles (about 4-5 months). After the last cycle, as long as the participant is showing benefit, they may elect to continue taking PCI-24781 alone, in which case they will continue in this research study until there is evidence of their tumor growing.

PCI-24781 in Combination With Doxorubicin to Treat Sarcoma

Phase I/II Study of PCI-24781 in Combination With Doxorubicin for Treatment of Advanced Sarcomas Following Failure or Prior Anthracycline Therapy

number of patients who experienced dose limiting toxicities

number of patients who demonstrated partial response to therapy as determined by RECIST v1.0 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Pharmacyclics LLC.

Massachusetts General Hospital

Principle Investigator

Patients in this arm were not mandated treatment with GCSF

PCI-24781+Dox Without Mandated GCSF

Patients in this are were mandated treatment with GCSF

PCI-24781+Dox With Mandated GCSF

Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.

PCI-24781 + Doxorubicin Without Mandatory GCSF

Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.

PCI-24781 + Doxorubicin With Mandatory GCSF

Dr. Edwin Choy

PCI-24781 With Mandatory GCSF

The two groups differ in that GCSF was offered if clinically indicated in arm 1 while it was administered to all participants in arm 2.

Maximum Tolerated Dose

Optional GCSF

Mandatory GCSF

Dose Limiting Toxicities

Number of Partial Responses (PR)

Rate of Progression-free Survival at 6 Months in Participants Who Received PCI-24781/Doxorubicin Combination Administration.

PCI-24781 + Doxorubicin without mandatory GCSF

PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle

PCI-24781 + Doxorubicin with mandatory GCSF

PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle

Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle

Skin and Connective Tissue Diseases

Breast Neoplasms

Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Leukocyte Disorders

Granulocytopenia

Docetaxel

Epirubicin

Lenograstim

Adjuvants, Immunologic

intervention: rHSA-GCSF 2.4 mg Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.

TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.

Recombinant Human Serum Albumin/Granulocyte Colony-Stimulating Factor Fusion Protein（2.4mg）will be injected subcutaneously at at 10 am (±90 min) on the 3th and 7th day of each chemotherapy cycle.After injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. If not up to standard, investigator should decide whether or not the third administration.

intervention: GCSF Drug: TE or TEC TE: Taxotere+Epirubicin Taxotere (75mg/m2)and Epirubicin(75mg/m2), IV on day 1 of each 21 chemotherapy cycle.

TEC:Taxotere+Epirubicin+Cyclophosphamide Taxotere (75mg/m2),Epirubicin (75mg/m2) and Cyclophosphamide (500mg/m2), IV on day 1 of each 21 chemotherapy cycle.

Recombinant Human Granulocyte Colony-Stimulating Factor Injection (5μg/kg/day) will be injected subcutaneously at 10 am (±90 min) from the 3rd of per chemotherapy cycle. After the injection, stop administrating if Absolute Neutrophil Count (ANC) in peripheral blood exceeded 5.0×109/L at two contiguous times at least. (The minimum of usage was continuous 7 days ,The maximum of usage was continuous 14 days)

Human Serum Albumin GCSF 2.4mg at day 3 and day 7

rHSA-GCSF 2.4mg

Binghe XU, MD

Evaluation of the efficacy and safety of recombinant human serum albumin / granulocyte-stimulating factor fusion protein for injection to prevent chemotherapy-induced neutropenia

* Brief Protocol: Treat the patients taking Taxotere+Epirubicin +Cyclophosphamide (TEC) treatment or Taxotere+Epirubicin (TE)treatment chemotherapy with the study medicine or positive control during the period between two chemotherapy treatments.
* Targeted patients: breast cancer
* Subjects were randomly divided into two groups. The test group received recombinant human serum albumin / granulocyte thorns for injection Stimulant fusion protein 2.4mg treatment. Positive control group received recombinant human granulocyte colony stimuli Factor injection therapy
* Number of patients: 80

Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients

Efficacy and Safety Phase IIb Study of Recombinant Human Serum Albumin/ Granulocyte Colony-Stimulating Factor Fusion Protein for Injection to Prevent Neutrophilic Granulocytopenia Among Chemotherapy Breast Cancer Patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
HLA-Compatible Related or Unrelated Donors With CD34+ Enriched, T-cell Depleted Peripheral Blood Stem Cells Isolated by the CliniMACS System in the Treatment of Patients With Hematologic Malignancies	NCT01119066	Acute Lymphobla... Acute Myelogeno... Myelodysplastic... Multiple Myelom...	total body irra... Thiotepa Cyclophosphamid... Busulfan Melphalan Fludarabine Clofarabine (CliniMACS) T-c...	- 69 Years	Memorial Sloan Kettering Cancer Center
PCI-24781 in Combination With Doxorubicin to Treat Sarcoma	NCT01027910	Sarcoma	PCI-24781 Doxorubicin GCSF	18 Years -	Massachusetts General Hospital
Recombinant Human Serum Albumin/Granulocyte Colony Stimulating Factor Fusion Protein for Breast Cancer Patients	NCT03251768	Chemotherapy-in...	rHSA-GCSF 2.4mg GCSF	18 Years - 65 Years	Tianjin SinoBiotech Ltd.
Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma	NCT05498220	Diffuse Large B...	Polatuzumab ved... Rituximab Hyaluronidase Gemcitabine Cisplatin Dexamethasone GCSF	18 Years -	UNC Lineberger Comprehensive Cancer Center
Effectiveness of Reduced GCSF Dosing in Patients With a Low to Moderate Risk of Febrile Neutropenia	NCT01658956	Breast Cancer	GCSF administra...	-	Jules Bordet Institute
Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma	NCT05498220	Diffuse Large B...	Polatuzumab ved... Rituximab Hyaluronidase Gemcitabine Cisplatin Dexamethasone GCSF	18 Years -	UNC Lineberger Comprehensive Cancer Center
Meloxicam vs Placebo for Mobilization	NCT02003625	Non-Hodgkin's L... Hodgkin's Lymph... Multiple Myelom... Hematopoietic S...	GCSF meloxicam Placebo	18 Years - 75 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for gcsf

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

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