Lymphoma

questionnaire

CHU de Nice

Signal Detection in Monoclonal and New Agents in Lymphoma

Detection of Long Term Toxicity of Monoclonal Agents Combined With Chemotherapy in Non-Hodgkin Lymphoma - the SIMONAL Project

Disproportionate reporting of health problems in relation with neuro-psychiatric troubles, cardio-vascular diseases, digestive tract diseases etc.

Disproportionate reporting of health care use (drug consumption, hospitalization, doctors consultations)

Centre Hospitalier Universitaire de Nice

Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.

TST/Iodine I-131 TST

Gender

Race/Ethnicity, Customized

Hematology parameter grades were summarized according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 2.0. Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; Grade 5, death. Data are presented for those participants who experienced Grade 4 toxicities. Grade 4 hematological toxicities included absolute neutrophil count (ANC) (calculated) <1000 cells/millimeters cubed (mm^3), white blood cells (WBC) <2000 cells/mm^3, platelets <50000 cells/mm^3, and hemoglobin < 8.0 grams/deciliter.

Number of Participants With the Indicated Grade 4 Hematology Toxicities Following Iodine-131 Anti-B1 Antibody

CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and normalization of biochemical abnormalities definitely assignable to non Hodgkin's lymphoma (NHL). PR is defined as a >=50% decrease in the sum of perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. SD is defined as less than a PR, but not PD, which is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. RD is defined as the appearance of any new lesion or an increase of >= 50% in the size of nodules. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.

Number of Participants (Par.) With Confirmed (Con.) Complete Response (CR) Confirmed, Confirmed Complete Response Unconfirmed (CRu), Confirmed Partial Response (PR), Relapse Disease (RD), and Progressive Disease (PD)

Duration of response for all participants with confirmed PR, confirmed CRu, or confirmed CR is defined as the time from the first documented response to the first documented progression. CR is defined as the complete disappearance of all detectable clinical/radiographic evidence of disease, the disappearance of all disease-related symptoms if present before therapy, and the normalization of biochemical abnormalities definitely assignable to NHL. PR is defined as a >=50% decrease in the sum of the perpendicular diameters (SPPD) of splenic and hepatic nodules determined at Baseline. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination. Confirmed response requires that the same or better response be confirmed by two consecutive post-therapy response evaluations at least 4 weeks apart.

Duration of Response and Duration of Confirmed Complete Response

PFS is defined as the time from the start of treatment to the first documented progression or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.

Progression-free Survival (PFS)

TTF is defined as the time from the start of treatment to the first occurrence of treatment withdrawal, decision to seek additional therapy, study removal, disease progression, or death. Duration measures were calculated using Kaplan-Meier techniques. Disease progression was based on radiographic or photographic evidence, and assessments were made by the investigator. PD is defined as a >=50% increase from nadir in SPPD of splenic and hepatic nodules or the appearance of any new lesion during or at the end of therapy that was >1.5 centimeters (cm) by radiographic evaluation or >1.0 cm by physical examination.

Time to Treatment Failure (TTF)

TBRT is the time at which the activity of infusion is 37% of that at time zero. Whole body images from anterior and posterior gamma camera scans were collected to assess dosimetry. The assessment of organ dosimetry required gamma camera scans from at least 4 time points. Nuclear medicine reviewers conducted a visual examination of the gamma camera scans and calculated the TBRTs. Residence time is calculated from the rate of total body clearance of iodine I-131 radioactivity during the dosimetric dose. Residence time is a measure of how long the drug resides in the body.

Total Body Residence Time (TBRT)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily have to have a casual relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or significant worsening of a pre-existing sign or symptom, or disease temporally associated with the use of a medicinal product. An SAE is defined as any experience occurring at any dose that results in the following outcomes: death, a life-threatening adverse experience, in-patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. See the SAE/AE module for a complete list of SAEs/AEs.

Number of Participants With an Adverse Experience, Including Adverse Events (AEs) and Serious Adverse Events (SAEs)

Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Time to recovery to Baseline grade for participants with Grade 0 toxicity at Baseline was defined as the time from the date of the last administration of study drug to the first post-nadir date with Grade 0 toxicity, with no other Grade 1-4 toxicities recorded during the next week. For participants with a Grade 1-4 toxicity at Baseline, time to recovery was defined as the time from the last administration of study drug to the first post-nadir date with a Baseline grade or better, with no other higher grade toxicities recorded during the next week. For participants with a nadir grade less than or equal to the Baseline grade, the time to recovery to the Baseline grade equaled the time to nadir.

Time to Recovery From the Indicated Hematology Toxicities

Hematology toxicities included ANC (calculated), hemoglobin, platelet count, WBC count. Nadir is defined as lowest counts that the cells reach after chemotherapy.

Nadir for the Indicated Hematology Toxicities

Hematology toxicities included ANC (calculated), WBC count, platelet count, and hemoglobin. Nadir is defined as the lowest counts (for ANC, WBC, and platelet counts)/concentration (for hemoglobin) that the cells reach after chemotherapy. Time to nadir is defined as the time from Baseline to the lowest value recorded up to 120 days following the therapeutic dose.

Time to Nadir for the Indicated Hematology Toxicities

During the administration of unlabeled Anti-B1 antibody and Iodine-131 Anti-B1 antibody, emergency support for anaphylaxis, including epinephrine, diphenhydramine, hydrocortisone, a laryngoscope, and an endotracheal tube, was readily available. The use of steroids were discouraged unless other measures were ineffective.

Number of Participants Needing Supportive Care at Week 7 and Week 13

The number of participants who developed human anti-murine (mouse) anibodies (HAMA) after treatment was measured.

Number of Participants Converting to Human Anti-Murine (Mouse) Antibody (HAMA) Positivity at Any Follow-up Visit From HAMA Negativity at Baseline

Overall survival (time to death) is defined from the start of treatment to the date of death from any cause.

Overall Survival

Overall Study

GSK Response Center

Lymphoma, Non-Hodgkin

Subjects received the following treatments of TST/I-131 TST by intravenous (IV) infusion:
Dosimetric Dose: 450 mg of TST infused over 1 hour immediately followed by 35 mg of TST labeled with 5 milliCuries (mCi) of I 131 infused over 30 minutes.
Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 60 minutes, immediately followed by 35 mg of TST labeled with the subject-specific mCi activity of I 131 needed to deliver a total body dose of 75 centiGrays (cGy), infused over 30 minutes for subjects with a platelet count of 150,000/mm3. Subjects with platelet counts of 100,000 to 149,999/mm3 received 65 cGy, and obese subjects were dosed based upon 137% of their calculated lean body mass.

tositumomab and iodine I-131 tositumomab

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-line CHOP

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

GlaxoSmithKline

Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.

Acute Lymphoblastic Leukemia

Untreated Childhood Acute Lymphoblastic Leukemia

Daunorubicin Hydrochloride

Pharmacological Study

Prednisolone

Prednisone

Vincristine Sulfate

Childrens Oncology Group

Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia

Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)

Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.

To examine the relationship between pharmacokinetic parameters and RER versus SER status, univariate and multiple logistic regressions will be performed.

Children's Oncology Group

National Cancer Institute (NCI)

Patients in this arm were randomized to intramuscular native E coli L-asparaginase 25 000 IU/m2 weekly for 30 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.

Patients in this arm were randomized to intravenous PEG-asparaginase 2500 IU/m2 every 2 weeks for 15 doses. Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization. Further details are provided in the study description section.

Intramuscular Native E Coli L-asparaginase (IM-EC)

Intravenous PEG-asparaginase (IV-PEG)

Ph+ ALL patients did not participate in asparaginase randomization but were directly assigned to receive intramuscular E coli L-asparaginase during post-induction therapy. Patients who were eligible but declined randomization were also directly assigned to receive intramuscular E coli L-asparaginase.

IM-EC [Directly Assigned]

All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who did not achieve complete remission and were not assigned a final risk group by the end of the induction phase of treatment were not eligible for randomization. Patients who developed severe pancreatitis (defined as symptoms persisting for >72 h) during induction were not eligible for randomization and received no further doses of asparaginase. Patients who had hypersensitivity to intravenous PEG-asparaginase during induction were also ineligible for randomization, but received twice-weekly IM-EC (25 000 IU/m2) during the post-induction treatment phases.

Ineligible for Randomization

Patients were enrolled in an expansion cohort to determine the prognostic significance of response to remission induction chemotherapy as measured by morphologic and minimal residual disease (MRD), and to further evaluate the efficacy of patients by final risk classification.

Expansion Cohort

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Age Classification

Asparaginase-related toxicity rate is defined as the percentage of patients who experience allergy (all grades), symptomatic pancreatitis (grade 2 or worse), thrombotic or bleeding complications requiring intervention (grade 2 or worse) with treatment attribution of possibly, probably or definite based on CTCAEv3.

Asparaginase-Related Toxicity Rate

Disease-free survival (DFS) in a landmark analysis is defined as the duration of time from asparaginase randomization (which occurred after patients achieved complete remission and were assigned to a final risk group) to documented relapse, death during remission or second malignant neoplasm. DFS is estimated based on the Kaplan-Meier method and 5-year DFS is the probability of patients remaining alive, relapse-free and without occurrence of second malignant neoplasm 5 years from asparaginase randomization. Disease relapse is defined as >25% lymphoblasts identified morphologically in bone marrow aspirate/biopsy, or identification of lymphoblasts in marrow (any percentage) identified to be leukemic by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests. Appearance of leukemic cells at any extramedullary site (a single, unequivocal lymphoblast in the CSF may qualify as CNS leukemia) also qualifies if confirmed by the PI.

5-Year Disease-Free Survival

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods.

Post-Induction Nadir Serum Asparaginase Activity Level

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Post-Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL ever during post-induction therapy.

Post-Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Infection toxicity rate is defined as the percentage of patients who experience bacterial or fungal infection of grade 3 or higher with treatment attribution of possibly, probably or definite based on CTCAEv3 during remission induction phase of combination chemotherapy.

Protocol therapy was comprised of 5 phases: Induction, Consolidation I, CNS, Consolidation II, Continuation and varied dependent on risk classification. All patients received a single dose of intravenous PEG-asparaginase 2500 IU/m2 during multi-agent induction. Patients who achieved complete remission after induction were eligible for post-induction asparaginase randomization wherein patients received either E. coli L-asparaginase or peg-asparaginase. Standard risk and high-risk patients began post-induction randomized asparaginase therapy at the start of the CNS phase, whereas very high-risk patients began asparaginase therapy on day 8 of consolidation phase IC. Patients who did not achieve complete remission by the end of the induction phase were not eligible for randomization, were removed from protocol treatment, and received alternative therapy according to the discretion of their treating physician. Further details are provided in the study description section.

Overall

Induction Infection Toxicity Rate

Serum asparaginase activity (NSAA) levels were estimated based on established methods.

Induction Serum Asparaginase Activity Level

Nadir serum asparaginase activity (NSAA) levels were estimated based on established methods. Induction therapeutic NSAA rate is defined as the percentage of patients achieving a NSAA level above 0.1 IU/mL at a given timepoint.

Induction Therapeutic Nadir Serum Asparaginase Activity Rate

Low end-induction (day 32) minimal residual disease (MRD) evaluated was defined as <0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods.

Low Day 32 MRD Level

High end-induction (day 32) minimal residual disease (MRD) evaluated was defined as >/=0.001. This MRD classification was one component of determining final risk classification. Peripheral blood samples were collected for evaluation of MRD using PCR methods

High Day 32 MRD Level

5-Year Disease-Free Survival by MRD Day 32 Status

M1 marrow morphology at day 18 was defined as <5% blasts.

M1 Day 18 Bone Marrow Status

M2 marrow morphology at day 18 was defined as 5-24% blasts. M3 marrow morphology at day 18 was defined as >25% blasts.

M2/M3 Day 18 Bone Marrow Status

Hypocellular marrow morphology at day 18 was defined as empty blasts.

Hypocellular Day 18 Bone Marrow Status

5-Year Disease-Free Survival by Bone Marrow Day 18 Status

CNS-1: no blast cells in cytospin, regardless of cerebrospinal fluid (CSF) count

CNS-1

CNS-2: 5 or fewer WBC on CSF cell count, with blasts on cytospin

CNS-2

CNS-3: more than 5 WBC on CSF cell count, with blasts on cytospin

CNS-3

Traumatic Tap with Blasts: with blast cells and >100 RBCs on a wet prep

Traumatic Tap With Blasts

Traumatic Tap without Blasts: without blast cells and >100 RBCs on a wet prep

vincristine/obezitate

Signal Detection in Monoclonal and New Agents in Lymphoma

Iodine-131 Anti-B1 Antibody Consolidation for Patients With Non-Hodgkin's Lymphoma Following First-line CHOP

Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia

Treatment of Acute Lymphoblastic Leukemia in Children

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