Bendamustine Study in Classical Hodgkin Lymphoma Patients Over 60 Treated by Prednisone, Vinblastine and Doxorubicin (PVAB)
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| ClinicalTrials.gov Identifier: NCT02414568 |
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Recruitment Status :
Completed
First Posted : April 10, 2015
Last Update Posted : February 21, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Classical Hodgkin Lymphoma | Drug: Bendamustine Drug: Prednisone Drug: Vinblastine Drug: Doxorubicin | Phase 2 |
The usual treatment for Hodgkin lymphoma is chemotherapy Adriamycin (also known as doxorubicin) + Bleomycin + Vinblastine + Dacarbazine (ABVD). Studies have shown that patients aged over 60 years have a lower tolerance and efficiency during this treatment than younger patients. There are particular pulmonary toxicities with bleomycin included in the ABVD treatment.
Alternative treatment strategies have been proposed removing bleomycin in the Prednisone + Vinblastine + Adriamycin/Doxorubicin +Gemcitabine (PVAG) protocol evaluated in more than 60 patients. Compared to ABVD treatment, PVAG treatment presented a more favorable toxicity profile. The quality of response between the two treatments is substantially equal.
Bendamustine was evaluated in four studies in patients with Hodgkin lymphoma in relapse and showed higher efficacy than gemcitabine with an acceptable toxicity profile.
In this study, the Sponsor and the coordinating investigator propose to replace dacarbazine in the standard ABVD protocol by bendamustine and to stop using bleomycin.
The main objective of this study is to evaluate the safety and efficacy of bendamustine in patients treated with prednisone, vinblastine and doxorubicin. This is the PVAB treatment with which LYSARC and the coordinating investigator expect better tolerability and quality response.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 90 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Masking Description: | Open label |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective Phase II Study of Bendamustine in Patients Aged Over 60 Years With Classical Hodgkin Lymphoma Treated by Prednisone, Vinblastine and Doxorubicin |
| Actual Study Start Date : | July 17, 2015 |
| Actual Primary Completion Date : | December 14, 2018 |
| Actual Study Completion Date : | November 10, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PVAB regimen
Prednisone 40 mg/m2 (PO) Days 1-5 ; Vinblastine 6 mg/m2 (IV) Day 1 ; Doxorubicin 40 mg/m2 (IV) Day 1 ; Bendamustine 120 mg/m2 (IV) Day 1
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Drug: Bendamustine
Bendamustine 120 mg/m2 (IV) Day 1
Other Name: LEVACT Drug: Prednisone Prednisone 40 mg/m² PO
Other Name: CORTANCYL Drug: Vinblastine Vinblastine 6 mg/m² IV
Other Name: VELBE Drug: Doxorubicin Doxorubicin 40 mg/m² IV
Other Name: ADRIBLASTINE |
- Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification [ Time Frame: 3 years ]Complete Metabolic Response rate at the end of study treatment (after 6 cycles of study treatment or at premature treatment discontinuation) defined according to Lugano Classification
- Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay) [ Time Frame: 5 years ]Feasibility of the protocol, with adequate protocol adherence (adequate dose without excessive delay)
- Safety profile including immediate toxicities and non-tumor events [ Time Frame: 5 years ]Safety profile including immediate toxicities and non-tumor events
- Progression-free survival [ Time Frame: 5 years ]Progression-free survival
- Disease-free survival [ Time Frame: 5 years ]Disease-free survival
- Overall survival [ Time Frame: 5 years ]Overall survival
- Geriatric assessment program [ Time Frame: 5 years ]7 Quality of Life Questionnaires (QLQ)
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| Ages Eligible for Study: | 61 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patient with a first diagnosis of classical Hodgkin lymphoma according to the World Health Organization (WHO) criteria excluding nodular lymphocyte predominant subtype
- Age of 61 years or older
- No previous treatment for Hodgkin lymphoma
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Ann Arbor stages:
- II with mediastinum/thorax ≥0.33 or extranodal localization and with B symptoms
- Or III
- Or IV
- Baseline 18-FluoroDeoxyGlucose (FDG) PET scan (PET0) performed before any treatment with at least one hypermetabolic lesion
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate cardio-pulmonary function with Left Ventricular Ejection Fraction (LVEF) ≥ 50%
- Adequate renal function with creatinine clearance ≥ 40 mL/mn (MDRD formula)
- For patients aged 70 years old and more, a Mini Nutritional Assessment (MNA) ≥ 17
- A minimum life expectancy of 3 months
- Negative Human Immunodeficiency Virus, Hepatitis B (HB) Virus (anti-HB c negativity) and Hepatitis C Virus serologies tests ≤ 30 days before inclusion (except after vaccination)
- Having previously signed a written informed consent
- The patient must be covered by a social security system, if applicable
- Men patient must agree to use an adequate method of contraception during the study treatment and until 6 months after the end of the study treatment.
Exclusion Criteria:
- Any other type of lymphoma including nodular lymphocyte predominant subtype
- Any history of treated Hodgkin lymphoma
- Contra-indication to any drug contained in the chemotherapy regimens
- Any serious active disease (according to the investigator's decision)
- Poor hepatic function (total bilirubin level > 30 μmol/L or transaminases > 2.5 maximum normal level) unless these abnormalities are related to the lymphoma
- Poor bone marrow reserve as defined by leukocytes < 2 G/L or platelets < 100 G/L, unless related to bone marrow infiltration
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Any history of cancer during the last 3 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if they fulfil all the followings:
- their disease was T1-T2a, N0, M0, with a Gleason score ≤ 7, and a prostate specific antigen (PSA) ≤ 10 ng/mL prior to initial therapy,
- they had definitive curative therapy (i.e. prostatectomy or radiotherapy) ≥ 2 years before Day 1 of Cycle 1,
- at a minimum 2 years following therapy, they had no clinical evidence of prostate cancer and their PSA was undetectable if they underwent prostatectomy or < 1 ng/mL if they did not undergo prostatectomy
- Severe metabolic disease interfering with normal application of protocol treatment as uncontrolled diabetes mellitus leading to impossibility to perform PET scan
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- Adult under tutelage
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414568
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| Principal Investigator: | Hervé Ghesquières, MD | The Lymphoma Academic Research Organisation |
| Responsible Party: | The Lymphoma Academic Research Organisation |
| ClinicalTrials.gov Identifier: | NCT02414568 |
| Other Study ID Numbers: |
PVAB |
| First Posted: | April 10, 2015 Key Record Dates |
| Last Update Posted: | February 21, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lymphoma Hodgkin Disease Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Doxorubicin Bendamustine Hydrochloride Vinblastine Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors |
Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Antineoplastic Agents, Alkylating Alkylating Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |