50 colorectal cancer patients receiving FOLFOX 6: (Oxaliplatin 85mg/m2 IV over 2 hrs + leucovorin 400mg/m2 IV over 2 hrs, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) in addittion to atorvastatin (20 mg once daily) or FOLFIRI 6:( Irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) in addittion to atorvastatin (20 mg once daily) in addittion to atorvastatin (20 mg once daily)

50 colorectal cancer patients receiving FOLFOX 6: (Oxaliplatin 85mg/m2 IV over 2 hrs + leucovorin 400mg/m2 IV over 2 hrs, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks) or FOLFIRI 6:( Irinotecan 180mg/m2 IV + leucovorin 400mg/m2 IV, followed by 5-FU 400mg/m2 IV bolus, followed by 5-FU 1,200mg/m2 /day IV x 2 days (total 2,400mg/m2 ) as a 46-48 hr continuous infusion. Repeat every 2 weeks)

Colorectal Cancer

Atorvastatin 20mg

Faculty of Pharmacy

Effect of Atorvastatin on 5-Fluorouracil Induced Mucositis

The Effect of Atorvastatin on The Prevention of 5-fluorouracil-induced Mucositis in Colorectal Cancer Patients

screening the patients seeking mucositis & grading mucositis using Common Terminology Criteria for Adverse Events, CTCAE version 5 ( ranging from grade 1 of better outcome to 5 of worst outcome ) and evaluating the effect of atorvastatin on mucositis

the grade of mucositis will be assessed using common terminology criteria of adverse effects version 5

the pain due to mucositis will be assessed using visual analogue scale

The Oral Health Impact Proﬁle-14 (OHIP-14) will be used to assess the effect of mucositis on the patients' liferanging from 0 of better outcome to 56 of worst outcome

serum ALT and AST will be assessed before each cycle

serum tumor necrosis factor α (TNF-α) will be assessed at baseline and after 6 months

Radwa Salah Lotfy Abdel-Rahman

Clinical Pharmacist at nasser institute

Ain Shams University

Nasser Institute For Research and Treatment

Prospective, Randomized, controlled, open-label pilot study will be conducted on 100 colon cancer patients receiving 5-FU adjuvant FOLFOX -6 & FOLFIRI-6 therapy.

Cold Agglutinin Disease

Autoimmune Hemolytic Anemia

Bendamustine, Rituximab

Herlev University Hospital

Turku University Hospital

Haukeland University Hospital

Vestre Viken Hospital

Haugesund Hospital

Akershus University Hospital

Oslo University Hospital

St Olav University Hospital

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

The CAD5 Study::Therapy for Chronic Cold Agglutinin Disease: A Prospective, Non-randomized International Multicenter Trial on the Safety and Efficacy of Bendamustine and Rituximab Combination Therapy

Responses will be assessed using the following, previously published definitions:
Complete response (CR), Absence of anemia, no signs of hemolysis, no clinical symptoms of CAD, undetectable serum monoclonal protein, and no signs of clonal lymphoproliferation by bone marrow histology, immunohistochemistry and flow cytometry.
Partial response (PR), Stable increase in hemoglobin levels by at least 2.0 g/dL or to the normal range, combined with a reduction of serum IgM concentrations by at least 50% or to the normal range, improvement of clinical symptoms, and transfusion independency.
Non-response (NR), Patients not meeting the criteria for CR or PR.

Time to response (TTR) is the time from start of therapy to the achievement of any degree of response.

Time to best response (TTBR) is the time from start of therapy to the observation of the highest hemoglobin level achieved + 0.5 g/dL.

Response duration is the time from achievement of any degree of response to relapse. Relapse is defined by one or more of the following events: A decline in hemoglobin level by at least 2.0 g/dL from the highest level achieved or to below 10.0 g/dL; transfusion requirement; or recurrence of significant cold-induced circulatory symptoms.

Data are to be shared between authors before final analysis and publication.

Sigbjorn Berentsen

MD, PhD

Helse Fonna

Patients will be treated with dasatinib monotherapy 100mg daily. At four weeks patients will be re-evaluated. Patients with less than a partial response will receive fludarabine (orally 40mg/daily for 3 days q28) in addition to dasatinib.

Chronic Lymphocytic Leukemia

Chemo-refractory CLL patients will be treated with dasatinib monotherapy 100mg daily.Patients with less than a partial response at 4 weeks will receive fludarabine (orally 40mg/daily for 3 days q28) in addition to dasatinib for a maximum of 6 cycles. Patients with at least a partial response will continue dasatinib monotherapy. Patients that receive monotherapy after the initial 28 days and that develop progressive disease will 'cross-over' to the combination treatment.

Dasatinib

Maastricht university medical center

Academic Medical Center

Erasmus MC-Daniel den Hoed Cancer Center

University Medical Center Groningen

Dasatinib Combination for Chronic Lymphocytic Leukemia(CLL) With Refractory Disease

Dasatinib Combination for Chronic Lymphocytic Leukemia Patients With Chemo Refractory Disease

A.P. Kater

A.P. Kater, MD, PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT).
Pre-conditioning therapy:
All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Patients will receive anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6.
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
Patient will then receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3.
Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600.
Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.
Rituximab: Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines.

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines

Conditioning Followed by HCT

Sex: Female, Male

Region of Enrollment

The primary endpoint was achievement of >/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).

Incidence of Greater Than or Equal to 50% Donor Chimerism

Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) >/= 500/µl for 3 consecutive days or a platelet count of >/= 20,000//µl without the need for platelet support.

Cumulative Incidence of Hematopoietic Cell Engraftment

Median Percentage of Donor Cells in Study Population (Chimerism).

Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28

Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100

The cumulative incidence of NRM after allo-HCT.

Non-relapse Mortality Rate (NRM)

Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.

Incidence of Infections

The median time from allo-HCT to the initiation of tacrolimus (TAC) taper.
The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration.

Time to Incidence of Graft Versus Host Disease (GVHD)

By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4.
At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD.
At 2 years, the cumulative incidence of moderate/severe chronic GVHD.

Incidence of Graft Versus Host Disease (GVHD)

PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., >5% blast in bone marrow or any peripheral blasts).

Percentage of Participants With Progression Free Survival (PFS)

OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.

Percentage of Participants With Overall Survival (OS)

Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.
Conditioning:
Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4
Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3
Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600
Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines

Overall Study

Marcie Riches, MD

Hematologic Malignancies

Pre-conditioning therapy:
All participants will receive pentostatin 4 mg/m^2 on day -28. Patients may receive additional doses on days -21 & -14 depending on cell counts.
Participant will receive pentostatin at a dose of 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3.

Pentostatin

Pre-conditioning therapy:
Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4.
Intravenous Busulfan (2nd dose) will be administered on day (-2) to target a total AUC of 16,000 +/- 1600.

Busulfan

Pre-conditioning therapy:
Patients with CD20+ expressing malignancies will be treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines.

Rituximab

Hematopoietic progenitor cells to be infused at least 36 hours after last dose of Busulfan.

Allogeneic Hematopoietic Cell Transplant

H. Lee Moffitt Cancer Center & Research Institute

Phase II Trial of Pentostatin and Targeted Busulfan

Phase II Trial of Pentostatin and Targeted Busulfan as a Novel Reduced Intensity Regimen for Allogeneic Hematopoietic Stem Cell Transplantation Using Laboratory-Guided (CD4-guided) Immunosuppression.

purine/erbrechen

Effect of Atorvastatin on 5-Fluorouracil Induced Mucositis

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

Dasatinib Combination for Chronic Lymphocytic Leukemia(CLL) With Refractory Disease

Phase II Trial of Pentostatin and Targeted Busulfan

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