Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Hodgkin Disease

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Hodgkin Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Antirheumatic Agents

Anti-Infective Agents

Gemcitabine

Dexamethasone

Rituximab

Melphalan

Lenograstim

Dexamethasone acetate

BB 1101

Busulfan

Vorinostat

Antineoplastic Agents, Immunological

Immunologic Factors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Antineoplastic Agents, Alkylating

Alkylating Agents

Immunosuppressive Agents

Histone Deacetylase Inhibitors

Enzyme Inhibitors

HIV Protease Inhibitors

Protease Inhibitors

Vorinostat 200 mg by mouth on Days -8 to -2. Gemcitabine loading dose of 75 mg/m2 followed by continuous infusion. Remaining dose is 10 mg/m2/min on Day -8 and -3. Busulfan pharmacokinetics (PK) will be performed with the first dose of 105 mg/m2 by vein on Day -8. The doses of days -6 and -5 will be subsequently adjusted to target an area under curve (AUC) of 4,000 microMol.min-1. In the event that PK adjusting were not possible, a dose of busulfan of 105 mg/m2 will be administered on days -6 and -5. Melphalan 60 mg/m2 by vein on Days -2 and -3. Stem cells by vein over about 30-60 minutes on Day 0. Rituximab 375 mg/m2 on days +1 and +8 for cluster of differentiation antigen 20 (CD20+) tumors. G-CSF 5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented. Palifermin 60 mcg/kg by vein daily for 6 doses starting on Day 0. Dexamethasone 8 mg by vein twice a day from day -8 AM to day -2 PM.

Starting dose: 200 mg by mouth on Days -8 to -2.

Starting dose: 2175 mg/m2 by vein on Days -8 and -3. This includes the gemcitabine 75 mg/m2 loading dose.

AUC: 4,000 micrometer (microM).min/day, or 105 mg/m2/day) on Days -8 to -5.

Pharmacokinetics will be performed with the first dose of 32 mg/m2 by vein on Day -8. The doses on Days -6 and -5 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting not possible, a dose of busulfan of 105 mg/m2 will be administered on days -6 and -5.

Stem Cell Infusion

375 mg/m2 on days +1 and +8 for patients with CD20+ tumors.

5 mcg/kg/day (rounded up the nearest vial) subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.

G-CSF

60 mcg/kg by vein daily for 6 doses. Three doses administrated prior to start chemo (24 hours must elapse between the last dose and first therapeutic dose of chemo) and three doses after the last chemo starting on day 0.

Palifermin

8 mg by vein twice a day from day -8 AM to day -2 PM.

Yago Nieto, MD,PHD

The goal of this clinical research study is to find the highest tolerable dose of vorinostat that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant. Researchers also want to learn about the safety and level of effectiveness of this combination.

Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.

Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as gemcitabine, busulfan and melphalan.

Study Groups:

If you are found to be eligible to take part in this study, you will be enrolled in a group of at least 3 participants to begin receiving the study drugs.

The dose of the study drugs you receive will depend on when you enrolled in this study. If no intolerable side effects occur in your group, researchers will continue to enroll participants at the next dose level until either the vorinostat reaches the dose level currently used alone without stem cell transplant, or the highest tolerable dose of this drug is found. The dose that you receive will remain the same throughout this study.

Busulfan Test Dose:

You will receive a test dose of busulfan by vein over about 60 minutes. This low-level test dose of busulfan is to check how the level of busulfan in your blood levels changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches your body size. You will most likely receive this as an outpatient during the week before you are admitted to the hospital. If it cannot be given as an outpatient, you will be admitted to the hospital on Day -11 (11 days before your stem cells are returned to your body) and the test dose will be given on Day -10.

About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor determine what your dose of busulfan should be on study. These blood samples will be drawn at various timepoints before you receive busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in your vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, you will receive the standard fixed dose of busulfan.

If you receive the busulfan test dose as an outpatient:

On Days -12, -11, and -10, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.

You will be admitted to the hospital on Day -9.

If you receive the busulfan test dose as an inpatient:

On Days -13, -12, and -11, you will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.

You will be admitted to the hospital on Day -11.

Study Drug Administration (for all patients):

In stem cell transplant, the days before you receive your stem cells are called minus days. The day you receive the stem cells is called Day 0. The days after you receive your stem cells are called plus days.

Beginning on Day -9, you will swish the liquids caphosol and glutamine in your mouth 4 times a day, for about 2 minutes each time. You will swish these liquids every day until you leave the hospital. These drugs are used to help decrease the risk of side effects in the mouth and throat.

On Day -8 through Day -2, you will take vorinostat by mouth, with food.

On Day -8, you will receive gemcitabine by vein over 3 1/2 - 4 1/2 hours and busulfan by vein over 3 hours.

On Days -8, -7, -6, and -5, you will receive busulfan by vein over 3 hours.

On Day -3, you will receive gemcitabine by vein over 3 1/2 - 4 1/2 hours and melphalan by vein over 30 minutes.

On Day -2, you will receive melphalan by vein over 30 minutes.

On Day -1, you will rest.

On Day 0, you will receive your stem cells by vein over about 30-60 minutes.

You will receive 3 more doses of palifermin by vein over 15-30 seconds on Days 0, +1 and +2.

If you have a B-cell cancer, you will receive rituximab (a treatment used for certain lymphomas or chronic lymphocytic leukemia) by vein over 3-6 hours as part of standard of care, on Days +1 and +8.

As part of standard care, you will receive G-CSF (filgrastim) as an injection just under your skin 1 time a day starting on Day +5 until your blood cell levels return to normal.

Study Tests:

On Day -1, you will have an electrocardiogram (ECG) to check your heart function.

About 30-100 days after the transplant, you will have lung function tests.

About 100 days after the transplant:

* Blood (about 4 teaspoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you may have a bone marrow aspiration and biopsy to check the status of the disease.
* You will have a CT scan of the neck, chest, abdomen, and pelvis to check the status of the disease.
* If the doctor thinks it is needed, you will have a PET scan to check the status of the disease.

Length of Study:

As part of standard care, you will remain in the hospital for about 3-4 weeks after the transplant. After you are released from the hospital, you will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.

You will be taken off study about 100 days after the transplant. You may be taken off study early if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

This is an investigational study. Vorinostat, gemcitabine, busulfan, melphalan, and rituximab are all FDA approved and commercially available. The use of these study drugs in combination is investigational.

Up to 80 patients will take part in this study. All will be enrolled at MD Anderson.

Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

Vorinostat (SAHA) Combined With High-Dose Gemcitabine, Busulfan, and Melphalan With Autologous Hematopoietic Cell Support for Patients With Relapsed or Refractory Lymphoid Malignancies

No more than 2 patients enrolled at one time in new dose level, until toxicities of at least 1 of those are assessed \& determined not to be DLT, no more patients enrolled at new dose level. Dose escalation of vorinostat starts at level 1a (200 mg/day) and Gemcitabine (2175 mg/m2/day). If level tolerable, dose proceeds from level 2a (300 mg) to level 11a (1000 mg) at increase of 100 mg per level. If level 1a were not tolerable, i.e., greater than 20% DLTs (determined by Continual Reassessment Method (CRM)), a decreased dose of gemcitabine (level 1b 1875 mg/m2) assigned and vorninostat escalation would be up to level 5b (600 mg) at increase of 100 mg per level instead.

Dose limiting toxicity (DLT) is defined as any grade 4 non-hematological, non-infectious toxicity attributable to the preparative regimen, or any grade 3 mucositis or skin toxicity that lasts more than 3 days at peak severity, or any grade 4 mucositis or skin toxicity of any duration.

M.D. Anderson Cancer Center

Symptoms and General Pathology

Syndrome

Leukemia

Leukemia, Myeloid

Preleukemia

Myelodysplastic Syndromes

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Hematologic Diseases

Bone Marrow Diseases

Myeloproliferative Disorders

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Heptavalent Pneumococcal Conjugate Vaccine

Mitogens

Palifermin once daily at a dose of 60 mg/kg/day for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).

Placebo at a dose of 1.2 mL (saline 0,9%) once daily for 3 days before the start of the conditioning regimen and then for 3 consecutive days starting on the day of transplantation (days 0 to day +2 inclusively).

Placebo

Ruth Seggewiss, MD

This is a double blind, placebo controlled clinical trial, where patients with an advanced form of blood cancer are treated with haploidentical allogeneic peripheral blood progenitor cell (PBPC) transplant after which they are randomised to receive either placebo or a keratinocyte growth factor (Palifermin or Kepivance®).

The function of Kepivance® is to stimulate the growth of epithelial cells. This drug has also been suggested to have an ability to help improve the reconstitution, or development, of the immune system after the transplantation.

The hypothesis is that the patients T-cell dependent humoral immune response to recall antigen (PrevenarTM) will be higher in in palifermin treated patients than in the placebo control group

Palifermin After Haploidentical PBSCT

Randomised Placebo-Controlled Double-Blind Phase II Study Applying Palifermin to Improve T-cell Immune Reconstitution After Haploidentical Allogeneic Peripheral Blood Progenitor Cell (PBPC) Transplantation

Amgen

European Society for Blood and Marrow Transplantation

Kim Champion

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Micronutrients

Hematinics

Vitamins

Amino Acids

Vitamin B 6

Pyridoxal

Pyridoxine

Folic Acid

Vitamin B Complex

Trace Elements

Vitamin B6

Glutamine

Folate

Vitamin B9

Busulfan test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5. Palifermin 60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2. SAHA 1,000 mg by mouth on Days -8 to -3. Gemcitabine loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3. Carfilzomib 27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1. SAHA 1,000 mg by mouth on Days -7 to -3. Melphalan 60 mg/m2 by vein on Days -3 and -2. Stem cell transplant on Day 0. Dexamethasone 8 mg by vein twice a day from Day -9 PM to Day -2 PM. Caphosol oral rinses 30 mL four times a day from Day -9 until discharge. Oral glutamine 15 g four times a day, swished, gargled and spit on Day -9 until discharge. Pyridoxine 100 mg by vein or mouth three times a day from Day -1.

27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1

Carfilzomib

SAHA

Loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3.

Test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5.

Stem Cell Transplant (SCT)

60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2.

8 mg by vein twice a day from Day -9 PM to Day -2 PM.

30 mL oral rinse four times a day from Day -9 until discharge.

Caphosol

15 g four times a day, swished, gargled and spit on Day -9 until discharge.

100 mg by vein or mouth three times a day from Day -1.

The goal of this clinical research study is to learn if carfilzomib and vorinostat combined with gemcitabine, busulfan, and melphalan with a stem cell transplant will help to control multiple myeloma (MM). Researchers also want to learn about the safety and effectiveness of this combination.

Busulfan Test Dose:

Participant will receive a test dose of busulfan by vein over about 60 minutes. This low-level test dose of busulfan is to check how the level of busulfan in participant's blood changes over time. This information will be used to decide the next dose needed to reach the target blood level that matches participant's body size. Participant will most likely receive this as an outpatient during the week before they are admitted to the hospital. If it cannot be given to participant as an outpatient, they will be admitted to the hospital on Day -11 (11 days before participant's stem cells are returned to their body) and the test dose will be given on Day -10.

About 11 samples of blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing of busulfan. PK testing measures the amount of study drug in the body at different time points and will help the study doctor decide what participant's dose of busulfan in this study should be. These blood samples will be drawn at various timepoints before participant receives busulfan and over about the next 11 hours. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in participant's vein to lower the number of needle sticks needed for these draws. If it is not possible for the PK tests to be performed for technical or scheduling reasons, participant will receive the standard fixed dose of busulfan.

If participant receives the busulfan test dose as an outpatient:

On Days -12, -11, and -10, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.

Participant will be admitted to the hospital on Day -9.

If participant receives the busulfan test dose as an inpatient:

On Days -14, -13, and -12, participant will receive palifermin by vein over about 30 seconds each day to help decrease the risk of side effects in the mouth and throat.

Participant will be admitted to the hospital on Day -11.

Study Drug Administration (for all participants):

With stem cell transplants, the days before participant receives their stem cells are called minus days. The day participant receives the stem cells is called Day 0. The days after participant receives their stem cells are called plus days.

Beginning on Day -9, participant will swish the liquids caphosol and glutamine in their mouth 4 times a day, for about 2 minutes each time. Participant will swish these liquids every day until they leave the hospital. These drugs are used to help decrease the risk of side effects in the mouth and throat.

On Day -9 through Day -2, participant will receive dexamethasone 2 times a day by vein over about 10 minutes.

On Day -8 through Day -2, participant will take vorinostat by mouth, with food.

On Day -8, participant will receive gemcitabine by vein over about 4 hours.

On Days -8, -7, -6, and -5, participant will receive busulfan by vein over about 3 hours.

On Days -7 and -6, participant will receive carfilzomib by vein over about 2-10 minutes.

On Day -3, participant will receive gemcitabine by vein over about 4 hours and melphalan by vein over 30 minutes.

On Day -2, participant will receive carfilzomib by vein over about 2-10 minutes and melphalan by vein over about 30 minutes.

On Day -1, participant will receive carfilzomib by vein over about 2-10 minutes.

On Day 0, participant will receive their stem cells by vein over about 30-60 minutes.

Participant will receive 3 more doses of palifermin by vein over about 15-30 seconds on Days 0, +1 and +2.

As part of standard care, participant will receive G-CSF (filgrastim) as an injection just under their skin 1 time a day starting on Day +5 until their blood cell levels return to normal.

Study Tests:

About 1 month, 100 days, 6 months, 1 year, and then about every 3-6 months for at least 2 years after the transplant:

* Participant will have a physical exam.
* Blood (about 4 tablespoons) will be drawn for routine tests, to learn how the transplant has taken, and to check the status of the disease.

About 100 days after the transplant, participant will have a bone marrow biopsy and aspiration to check the status of the disease. To collect a bone marrow biopsy and aspirate, an area of the hip or other site is numbed with anesthetic, and a small amount of bone and bone marrow is withdrawn through a large needle. This will be repeated once a year or earlier, if participant's doctor thinks it is needed.

Once a year, participant will have x-rays of all the bones in their body to check the status of the disease.

The study staff will also stay in contact with participant's local doctor to find out if the disease comes back and to check how they are doing.

Length of Treatment:

As part of standard care, participant will remain in the hospital for about 3-4 weeks after the transplant. After participant is released from the hospital, they will continue as an outpatient in the Houston area to be monitored for infections and transplant-related complications.

Participant will be taken off study about 2 years after the transplant. Participant may be taken off study early if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.

If for any reason participant wants to leave the study early, they must talk to the study doctor. It may be life-threatening to leave the study after participant has started to receive the study drugs but before they receive the stem cell transplant because their blood cell counts will be dangerously low.

This is an investigational study. Carfilzomib and melphalan are FDA approved for the treatment of MM. Vorinostat is FDA approved for the treatment of cutaneous lymphoma. Busulfan is FDA approved for the treatment of leukemia. Gemcitabine is FDA approved for the treatment of lymphoma, breast cancer, and lung cancer. The use of these study drugs in combination is investigational. The study doctor can explain how the study drugs are designed to work.

Up to 75 participants will take part in this study. All will be enrolled at MD Anderson.

Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma

Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Myeloma

Complete remission (CR) rate defined as percentage of number of complete responses in total number of patients treated.

Response rates (CR; CR/VGPR; RR) reported along with corresponding 95% confidence intervals. Logistic regression used to model the association between response rates and prognostic factors. Overall survival (OS) and progression free survival (PFS) estimated by the Kaplan-Meier method. Comparison of time to event endpoints by subgroups made using the log-rank test. Cox proportional hazards regression employed for univariate and multivariate analysis on time-to-event outcomes.

Mouth and Tooth Diseases

Digestive System Diseases

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid, Acute

Stomatitis

Mucositis

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

Etoposide

Cyclophosphamide

Etoposide phosphate

A 3 dose escalation design. Sucessive cohorts of patient (9 patients per group) will each be administered Palifermin as an IV bolus injection (40, 60 or 80 µg) once daily for 3 consecutive days before the start of conditioning regimen (chemotherapy and total body irradiation) and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).

Palifermin will be administered as an IV bolus injection (40, 60 or 80 µg/kg/day)once daily for 3 consecutive days before the start of conditioning regimen and after HCST (Day -10, -9, -8 and Day 0, +1, +2 respectively).

Total Body irradiation

Chemotherapy

Maarten de Chateau, MD, PhD

20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation \[TBI\]) followed by hematopoietic stem cell transplant (HSCT). The study will evaluate the safety and pharmacokinetics of palifermin in pediatric patients. Three doses (40 μg/kg/day, 60 μg/kg/day, and 80 μg/kg/day) are to be evaluated in each age group (1 to 2, 3 to 11, and 12 to 16 years, respectively) using a conventional dose escalation design. Palifermin is administered for 3 consecutive days (Day -10 to Day -8, respectively) before the start of the conditioning regimen and for 3 consecutive days (Day 0 to Day +2) following HSCT. Patients will be enrolled simultaneously to each age group to identify a safe, well tolerated, efficacious dose in each age group. Patients will also be followed for secondary malignancies, progression-free survival (PFS) and overall survival (OS)

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT

A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Pediatric Subjects With Acute Leukemias Undergoing Myeloablative Therapy and Allogeneic Hematopoietic Stem Cell Transplant (HSCT)

A DLT is appearance of side effects during treatment severe enough to prevent further increase in dosage or strength of treatment agent, or to prevent continuation of treatment at any dosage level.

A DLT was defined as: Grade 3 or 4 AE \[based on Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events (CTCAE) v3.0\] considered by the investigator to be related to palifermin with the exceptions: Grade 3 erythema, pruritus or rash that resolves within 7 days of the last dose of palifermin.

The percentage of particiapnts with a DLT during the study was assessed.

The percentage of participants developing palifermin antibodies during the study was assessed.

The percentage of participants with a severe AE during the study was assessed.

The percentage of participants with a laboratory value outside the normal ranges during the study.

Clearence was estimated as dose divided by the area under serum concentration-time curve from time zero to infinity where the dose was given in amount palifermin actually administered.

The terminal half-life was calculated as ln(2)/lambda,z where lambda,z was estimated using at least three quantifiable serum concentrations of the terminal log-linear phase.

The AUC was estimated using the linear/log trapezoidal method for AUC0-tau from time zero to the end of the dosing interval (24 hours (hrs) post-dose)

Data collected at time points: 0, 2 minutes (min), 15 min, 30 min, 60 min, 2 hrs, 4 hrs, 6, hrs, 10, hrs and 24 hrs post-dose.

Progression free survival (PFS) was defined as the number of days between the date of first investigational product administration and the date when physical or radiological evidence of disease progression is determined or death (regardless of cause)

Overall survival was defined as the number of days from the date of first investigational product administration to the date of death (regardless of cause)

Swedish Orphan Biovitrum

All subjects from each age group (1-2, 3-11, 12-16 years)

All Subjects

Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts

Palifermin 40 µg/kg/Day

Palifermin 60 µg/kg/Day

Palifermin 80 µg/kg/Day

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

The original protocol included a long term follow-up (LTFU) phase up to 10 years. This was reduced in a protocol amendment to up to the time when the last enrolled subject had completed the day +100 follow-up.

Medical Program Director

Safety Analysis Set. This set consisted of subjects who received at least one dose of palifermin.

Incidence of Dose Limiting Toxicities (DLTs)

Incidence of Serum Palifermin Antibody Formation

Incidence of Severe Adverse Events (AEs)

Incidence of Laboratory Abnormalities

Pharmacokinetic Analysis Set. This set consists of all subjects who receive at least one dose of palifermin and who have a sufficient number of serum concentration data points to allow calculation of the pharmacokinetic variables.

Pharmacokinetics of Palifermin, Clearence (CL) After the 1st Intravenous (IV) Bolus Injection for Multiple Dose Levels

Pharmacokinetics of Palifermin, Volume of Distribution at Steady State (Vss) After the 1st IV Bolus Injection for Multiple Dose Levels

Pharmacokinetics of Palifermin, Terminal Half-life (t½,z) After the 1st IV Bolus Injection for Multiple Dose Levels

Pharmacokinetics of Palifermin, t½,z After the 3rd IV Bolus Injection for Multiple Dose Levels

Pharmacokinetics of Palifermin, Area Under the Concentration Time Curve From Zero to the End of the Dosing Interval (AUCtau) After the 1st IV Bolus Injection for Multiple Dose Levels

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies	NCT01421173	Lymphoma	Vorinostat Gemcitabine Busulfan Melphalan Stem Cell Infus... Rituximab G-CSF Palifermin Dexamethasone a...	12 Years - 65 Years	M.D. Anderson Cancer Center
Palifermin After Haploidentical PBSCT	NCT00570999	Non-Hodgkin's L... Acute Leukaemia Myelodysplastic... Chronic Myeloid... Osteomyelofibro...	Palifermin Placebo	18 Years - 65 Years	European Society for Blood and Marrow Transplantation
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma	NCT02114502	Myeloma	Carfilzomib SAHA Gemcitabine Busulfan Melphalan Stem Cell Trans... Palifermin Dexamethasone Caphosol Glutamine Pyridoxine	18 Years - 65 Years	M.D. Anderson Cancer Center
Palifermin After Haploidentical PBSCT	NCT00570999	Non-Hodgkin's L... Acute Leukaemia Myelodysplastic... Chronic Myeloid... Osteomyelofibro...	Palifermin Placebo	18 Years - 65 Years	European Society for Blood and Marrow Transplantation
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT	NCT00460421	Leukemia	Palifermin Total Body irra... Chemotherapy	1 Year - 16 Years	Swedish Orphan Biovitrum
Lenalidomide Combined With Vorinostat/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Diffuse Large B-Cell Lymphoma of the ABC Subtype	NCT02589145	Lymphoma	Lenalidomide Vorinostat Gemcitabine Busulfan Melphalan Rituximab Dexamethasone Caphosol Glutamine Pyridoxine Enoxaparin Stem Cell Trans... Palifermin	15 Years - 65 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for kepivance

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

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