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-Infective Agents

Bleomycin

Vinblastine

Dacarbazine

Doxorubicin

Liposomal doxorubicin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

2 MBVD courses, after early restaging with PET scan (PET-2)

The subsequent treatment will be planned as follows:

* -Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36 Gy).
* -Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30 Gy) is optional.

MBVD will be scheduled as follows:

Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15

MBVD (Myocet+BVD)

Alessandro Levis, PhD

The study has the purpose to evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen.

STUDY POPULATION Patients affected by Hodgkin's lymphoma, any stage, older than 69 years. Patients affected by Hodgkin's Lymphoma with concomitant cardiopaty, older than 18 years.

AIMS OF THE STUDY

* To evaluate in elderly and/or cardiopathic HL patients, the cardiologic toxicity of the MBVD regimen, where liposomal doxorubicin (Myocet®) is substituted for doxorubicin in the conventional ABVD regimen
* To compare in a pair-match retrospective analysis the results obtained with MBVD with those obtained in patients comparable for clinical variables and treated with ABVD or with the reduced intensity VEPEMB schedule.

STUDY DESIGN Multi-centre phase II study SAMPLE SIZE 50 patients

STUDY PROCEDURES

* Histologic diagnosis of Hodgkin Lymphoma.
* Early Staging evaluation including:

  * Blood tests
  * CT, PET and bone marrow biopsy.
  * Heart and lung function evaluation.
  * Geriatric assessment.
  * Quality of life evaluation.
* 2 MBVD courses
* Early restaging with PET scan (PET-2)
* The subsequent treatment will be planned as follows:

  * Stage I and IIA patients will go on with 1 more course of MBVD (total of 3 courses) followed by involved field radiotherapy (30 Gy-36Gy).
  * Advanced stage (IIB-IV) patients will go on with 4 more courses of MBVD (total of 6 courses). Radiotherapy limited to bulky or non complete responder areas (30-36 Gy) is optional.
* Final restaging including:

  * Blood tests
  * CT, PET
  * bone marrow biopsy if positive at baseline.
  * Heart and lung function evaluation.
  * Geriatric assessment.
  * Quality of life evaluation

Follow up procedures will include:

1. a clinical and laboratory evaluation (with troponin, proBNP / BNP, cardiology visit, ECG and echocardiogram) every 6 months in the first 2 years, then annually.
2. CT scans will be planned annually.
3. Compilation of geriatric evaluation scales every 6 months in the first 2 years, then annually.

MBVD will be scheduled as follows (4 weeks):

Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15 Supportive treatment with G-CSF and/or Erythropoietin will be planned according to international guide-lines.

A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

A Phase II Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)

CR is defined according to the Cheson 2007 response criteria.

Evaluation of Cardiac Toxicity during the chemotherapy program measured by CTCAE v.3

Evaluation of cardiac toxicity of MBVD in elderly and/or cardiopathic patients with Hodgkin's lymphoma after two courses of MBVD.

PFS will be measured from the day of enrolment to the date of disease progression, relapse or death due to any cause

RFS is defined only for patients who achieve CR, and is measured from the date of attaining the disease-free state until the date of relapse or death from any cause

OS will be measured from the day of enrolment to the date of relapse or death due to any cause

Proportion of dose-intensity delivered to patients

Evaluate Change in cardiac markers during and at the end of chemotherapy

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Fondazione Italiana Linfomi - ETS

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Antirheumatic Agents

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.

2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.

Myocet

Nadia Harbeck, Prof. Dr.

Ulrike Nitz, Prof. Dr.

Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.

A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response

A Prospective, Multicenter, Open-label Comparison of Pre-surgical Myocet/ Cyclophosphamide (MC) q3w Followed by Either MC or Paclitaxel - Depending on Early Response Assessment by Ultrasound or by Toxicity for Elderly Non Frail Primary Breast Cancer Patients With Increased Risk of Relapse.

Teva Pharmaceuticals USA

West German Study Group

Trastuzumab

Jose Baselga, M.D.

The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.

Trial of Myocet in Metastatic Breast Cancer

A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

Sopherion Therapeutics

Antineoplastic Agents, Immunological

Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 40 mg/ square meter (m\^2), IV, every 3 weeks, from Week 1; if no dose limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles. Participants also received paclitaxel 60 mg/ m\^2, IV, once per week, from Week 19; if no DLT was observed in ≥ 2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.

Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours during Week 1, followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression. Participants also received myocet, 50 mg/m\^2, IV, every 3 weeks, from Week 1 for 6 cycles. Participants also received paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.

Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression

trastuzumab

60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression

paclitaxel

40 mg/m\^2 IV weekly; dose increased to 50 mg/m\^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles

Clinical Trials

This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer

'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'

For measurable disease, CR was defined as the disappearance of all clinically detectable disease determined by 2 observations not less than 4 weeks apart; and PR was defined as a 50 percent (%) decrease in the sum of the products of the 2 greatest diameters of all measurable lesions by 2 observations not less than 4 weeks apart, and no appearance of new lesions or progression of any lesion. For immeasurable disease, CR was defined as the complete disappearance of all known disease for at least 4 weeks; and PR was defined as an estimated decrease in tumor size of 50% or more for at least 4 weeks.

Disease progression was defined as the time from the start of treatment to the date of the first recorded incident of disease progression, or the date of death due any cause. For measurable disease, disease progression was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of greater than (\>)2 square centimeters (cm\^2), or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm\^2, an increase of ≥1 cm\^2. For immeasurable disease, disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.

The median time, in months, from the start of treatment to disease progression event.

Treatment response was defined as the time from the start of treatment to the date of recorded CR or PR of measurable disease.

The median time, in months, from the start of treatment to treatment response event.

Duration of response was defined as the time from date CR was first recorded to the date progressive disease (PD) was first noted. For measurable disease, PD was defined as a ≥25% increase in the sum of the products of diameters of 1 or more measurable lesions with a minimal area of \>2 cm\^2, or the appearance of new lesions; and for malignant lesions with a minimal area of 2 cm\^2, an increase of ≥1 cm\^2. For immeasurable disease, PD was defined as the appearance of any new lesion not previously identified or an estimated increase of ≥50% in existent lesions.

The median time, in months, from enrollment to duration of response event to Week 52.

Therapy failure was defined as the date of the start of therapy to the date of withdrawal due to adverse events, progressive disease/insufficient therapeutic response, death, failure to return, or refusal of treatment/lack of cooperation/withdrawal of consent. Participants were censored at the last dose of treatment if no event was recorded.

The median time, in months, from treatment start to therapy failure event. Participants were censored at the last date of treatment if no event was recorded.

OS was defined as the time from the date of the start of treatment to the date of death or the last date the participant was known to be alive.

The time, in months, from the start of treatment to OS event. The mean survival time and it's standard error were underestimated because the largest observation was censored and the estimation was restricted to the largest event time.

Hoffmann-La Roche

All participants who received at least 1 dose of study treatment and at least 1 safety follow-up were included in the safety analysis.

Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.

Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II

Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.

Trastuzumab, Doxorubicin, Paclitaxel; Phase I

Trastuzumab, Doxorubicin, Paclitaxel; Phase II

During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m\^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m\^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m\^2, IV, once per week, from Week 19 until disease progression.

Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II

Total

Age, Continuous

Sex: Female, Male

Medical Communications

All participants enrolled in Phase II of this study were included in the analysis.

Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to World Health Organization (WHO) Handbook for Reporting Results of Cancer Treatment

Time to Disease Progression - Percentage of Participants With an Event

Time to Disease Progression

Time to Treatment Response - Percentage of Participants With an Event

Time to Treatment Response

Only participants with a response were included in the analysis.

Duration of Response - Percentage of Participants With an Event

Duration of Response

Time to Therapy Failure - Percentage of Participants With an Event

Time to Therapy Failure

Overall Survival (OS) - Percentage of Participants With an Event

Overall Survival

Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m\^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m\^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m\^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m\^2, IV, and subsequently 80 mg/m\^2, IV, and continued until disease progression.

Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II

Overall Study

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hematologic Diseases

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dermatologic Agents

Reproductive Control Agents

Neuroprotective Agents

Micronutrients

Hematinics

Vitamins

Etoposide

Antibodies

Cytarabine

Fludarabine

Fludarabine phosphate

Dexamethasone

Methotrexate

Prednisone

Vincristine

Daunorubicin

Prednisolone

Immunomodulating Agents

Ifosfamide

Bortezomib

Dexamethasone acetate

Pegaspargase

Antibodies, Bispecific

Etoposide phosphate

Immunoglobulins

Blinatumomab

Mercaptopurine

Thioguanine

Methylprednisolone

Asparaginase

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Vindesine

Isophosphamide mustard

Proteasome Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antiviral Agents

Folinic Acid

Folate

Vitamin B9

Induction (5 wks): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT methotrexate (MTX)

Consolidation (6 w/4 w): "Consolidation extended" (control arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-mercaptopurine (6-MP), IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 years after initial diagnosis): 6-MP, MTX \[without preceding blinatumomab (control arm of randomization R-MR)\]

Erwinase is given in case of allergy to pegaspargase.

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)

Extra-compartment phase (8 wks): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 wks): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX \[without preceding blinatumomab (control arm of randomization R-MR)\]

Erwinase is given in case of allergy to pegaspargase.

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (given at 1.3 mg/m²/dose on days 50, 53, 56 and 59)

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX,IT MTX

Reinduction (6 weeks): "Protocol II" with dexamethasone, vincristine, doxorubicin, PEG-L-asparaginase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Blinatumomab (4 w): 1 cycle blinatumomab given at 15 µg/m²/day for 28 days (experimental arm of randomization R-MR)

Maintenance phase (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Induction (5 w): as in other pB arms

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT methotrexate, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX

Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide

Reinduction (3x4 w): "Protocol III" given 3 times with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX

Erwinase is given in case pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX).

Induction (5 w): as in other pB arms

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)

Intensified consolidation (3x5 d): Block HR-1' followed by HR-2' and HR-3' (control arm in randomization R-HR) with dexamethasone, vincristine, vindesine, daunorubicin, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, ifosfamide, pegaspargase, etoposide

Reinduction (3x4 w): as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Induction (5 w): as in other pB arms

Consolidation (6 w/4 w): "Consolidation extended" (control arm in randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase or "Consolidation short" (standard arm of early non-HR group) with cyclophosphamide, cytarabine, 6-MP, IT MTX

Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)

Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after init. diagnosis): 6-MP, MTX

Erwinase is given in case of pegaspargase allergy. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Induction (5 w): as in other pB arms

Consolidation (6 w): "Consolidation extended+BZM" (experimental arm of randomization R-eHR) with cyclophosphamide, cytarabine, 6-MP, IT MTX, dexamethasone, vincristine, pegaspargase, bortezomib (1.3 mg/m²/dose on days 50, 53, 56 and 59)

Intensified consolidation (1x5 d + 2x28 d): Block HR-1' with dexamethasone, vincristine, HD-MTX, IT MTX, HD-cytarabine, cyclophosphamide, pegaspargase followed by 2 cycles blinatumomab at 15 µg/m²/day for 28 days per cycle plus 2x2 doses IT MTX (experimental arm of randomization R-HR)

Reinduction (3x4 weeks): as in arm "pB: early (non-)HR-standard/HR-standard" Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Induction (5 w): "Protocol IA" with prednisolone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (4 w): "Consolidation short" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM

Consolidation (4 w): "Protocol IB regular" (control arm in randomization. R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"

HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX or "Protocol IA-CPM" with prednisolone instead of dexamethasone and additional CPM

Consolidation (6 w): "Protocol IB long" (experimental arm in randomization R-T) with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

non-HR extra-compartment phase and reinduction: as in arm "pB: early non-HR/SR"

HR intensified consolidation and reinduction: as in arm "pB: early (non-)HR-standard/HR-standard"

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase. Pts with poor response to intensified consolidation receive Myocet-FLA (Myocet, fludarabine, HD-cytarabine, IT-MTX)

Induction (5 w): "Protocol IA-Dexa" with prednisolone/dexamethasone, vincristine, daunorubicin, pegaspargase, IT MTX

Consolidation (4 w): "Protocol IB regular" with cyclophosphamide, cytarabine, 6-mercaptopurine, IT MTX

Extra-compartment phase (8 w): "Protocol M" with 6-MP, HD-MTX, IT MTX

Reinduction (6 w): "Protocol II" with dexamethasone, vincristine, doxorubicin, pegaspargase, IT MTX, cyclophosphamide, tioguanine, cytarabine

Maintenance (until 2 yrs after initial diagnosis): 6-MP, MTX

Erwinase is given in case of allergy to pegaspargase.

Experimental therapy in randomizations R-HR and R-MR

Experimental therapy in randomization R-eHR

Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Multi-centre Study of MBVD in Elderly and/or Cardiopathic Patients Affected by Hodgkin's Lymphoma (HL)	NCT01523847	Hodgkin Lymphom...	MBVD (Myocet+BV...	18 Years -	Fondazione Italiana Linfomi - ETS
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response	NCT02214381	Early Primary B...	Myocet Cyclophosphamid... Paclitaxel	70 Years -	West German Study Group
Trial of Myocet in Metastatic Breast Cancer	NCT00294996	Breast Cancer	Myocet	18 Years -	Sopherion Therapeutics
A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Patients With Metastatic or Locally Advanced Breast Cancer	NCT02015676	Breast Cancer	trastuzumab paclitaxel Myocet	18 Years - 70 Years	Hoffmann-La Roche
Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia - AIEOP-BFM ALL 2017	NCT03643276	Acute Lymphobla...	Blinatumomab Bortezomib Cyclophosphamid... Cytarabine Daunorubicin Myocet Dexamethasone Doxorubicin Etoposide Fludarabine Pho... Ifosfamide 6-Mercaptopurin... Methotrexate Pegaspargase Prednisolone Tioguanin Vincristine Vindesine Erwinase	- 17 Years	University Hospital Schleswig-Holstein
Trial of Myocet in Metastatic Breast Cancer	NCT00294996	Breast Cancer	Myocet	18 Years -	Sopherion Therapeutics
A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response	NCT02214381	Early Primary B...	Myocet Cyclophosphamid... Paclitaxel	70 Years -	West German Study Group

Spots Global Cancer Trial Database for myocet

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

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