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Doxorubicin Hydrochloride, Pembrolizumab, Vinblastine, and Dacarbazine in Treating Patients With Classical Hodgkin Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03331341
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 22, 2020
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Washington

Brief Summary:
This phase II trial studies the side effects of doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine in treating patients with classical Hodgkin lymphoma. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with pembrolizumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving doxorubicin hydrochloride, pembrolizumab, vinblastine, and dacarbazine may work better in treating classical Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Classical Hodgkin Lymphoma Drug: Dacarbazine Drug: Doxorubicin Hydrochloride Other: Laboratory Biomarker Analysis Biological: Pembrolizumab Drug: Vinblastine Phase 2

Detailed Description:

PRIMARY OBJECTIVE:

I. To estimate the safety of delivering 2 cycles doxorubicin hydrochloride (adriamycin), pembrolizumab, vinblastine and dacarbazine (APVD) to patients with previously untreated classical Hodgkin lymphoma (cHL).

SECONDARY OBJECTIVE:

I. To estimate the fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)2 negative (Deauville score 1-3) rate after 2 cycles of APVD.

OUTLINE:

Patients receive doxorubicin hydrochloride intravenously (IV), vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then for up to 5 years.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Trial of Adriamycin, Pembrolizumab, Vinblastine, and Dacarbazine (APVD) for Patients With Untreated Classical Hodgkin Lymphoma
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : July 1, 2026


Arm Intervention/treatment
Experimental: Treatment (APVD)
Patients receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV on days 1 and 15. Patients also receive pembrolizumab IV over 30 minutes on days 1 and 22 of cycle 1 and on day 15 of cycle 2. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity.
Drug: Dacarbazine
Given IV
Other Names:
  • 4-(Dimethyltriazeno)imidazole-5-carboxamide
  • 5-(Dimethyltriazeno)imidazole-4-carboxamide
  • Asercit
  • Biocarbazine
  • Dacarbazina
  • Dacarbazina Almirall
  • Dacarbazine - DTIC
  • Dacatic
  • Dakarbazin
  • Deticene
  • Detimedac
  • DIC
  • Dimethyl (triazeno) imidazolecarboxamide
  • Dimethyl Triazeno Imidazol Carboxamide
  • Dimethyl Triazeno Imidazole Carboxamide
  • dimethyl-triazeno-imidazole carboxamide
  • Dimethyl-triazeno-imidazole-carboximide
  • DTIC
  • DTIC-Dome
  • Fauldetic
  • Imidazole Carboxamide
  • Imidazole Carboxamide Dimethyltriazeno
  • WR-139007

Drug: Doxorubicin Hydrochloride
Given IV
Other Names:
  • 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)
  • ADM
  • Adriacin
  • Adriamycin
  • Adriamycin hydrochloride
  • Adriamycin PFS
  • Adriamycin RDF
  • ADRIAMYCIN, HYDROCHLORIDE
  • Adriamycine
  • Adriblastina
  • Adriblastine
  • Adrimedac
  • Chloridrato de Doxorrubicina
  • DOX
  • DOXO-CELL
  • Doxolem
  • Doxorubicin.HCl
  • Doxorubin
  • Farmiblastina
  • FI 106
  • FI-106
  • hydroxydaunorubicin
  • Rubex

Other: Laboratory Biomarker Analysis
Correlative studies

Biological: Pembrolizumab
Given IV
Other Names:
  • Keytruda
  • Lambrolizumab
  • MK-3475
  • SCH 900475

Drug: Vinblastine
Given IV
Other Names:
  • Vincaleucoblastine
  • VLB




Primary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 30 days after start of treatment ]
    Assessed using Common Terminology Criteria for Adverse Events version 4.0


Secondary Outcome Measures :
  1. Fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)2 negative (Deauville score 1-3) rate [ Time Frame: Up to 56 days (2 cycles) ]
    Proportion of fludeoxyglucose F-18 (FDG)-positron emission tomography (PET) 2 negative (Deauville score 1-3) patients after 2 cycles of doxorubicin hydrochloride (adriamycin), pembrolizumab, vinblastine and dacarbazine (APVD)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have cHL that has not been previously treated (patients who have received one dose [day 1 cycle 1] of standard doxorubicin hydrochloride [adriamycin], bleomycin, vinblastine and dacarbazine [ABVD] or doxorubicin hydrochloride, vinblastine, dacarbazine [AVD] may be enrolled as long as they completed all the required standard of care baseline studies before enrollment and initiate study therapy by day 15 cycle 1)
  • Patients must be appropriate candidates for at least 2 cycles of ABVD or AVD (this could include patients ranging from favorable risk early stage disease to poor prognosis advanced stage disease)
  • Patients must have measurable FDG-avid disease defined by standard criteria (Lugano 2014) and a minimum of 1.0 cm in diameter
  • Patients must have a FDG-PET-computed tomography (CT) of chest, abdomen, and pelvis within 56 days of enrollment
  • Patients should not have evidence of active central nervous system lymphoma
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
  • Patients must have a left ventricular ejection (LVEF) >= 50% within 56 days of enrollment
  • Patients must have adequate labs within 10 days of treatment unless cytopenia is thought to be due to underlying disease
  • Absolute neutrophil count (ANC) >= 1,500/mm^3 (without transfusion or growth factor support)
  • Platelets >= 100,000/mm^3 (without transfusion or growth factor support)
  • Serum creatinine < 1.5 mg/dl or creatinine clearance greater than 60/ ml per minute by the following formula (all tests must be performed within 28 days prior to registration)
  • Total bilirubin < 1.5 times upper limit of normal
  • Aspartate aminotransferase (AST) < 2.5 times upper limit of normal
  • All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines
  • Patients must be anticipated to complete at least 2 cycles of chemotherapy
  • Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication; if the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year

Exclusion Criteria:

  • Patients known positive for human immunodeficiency virus (HIV), or infectious hepatitis type B or C
  • Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
  • Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater, unless approved by the protocol chair or co-chair
  • Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen)
  • Active ischemic heart disease or congestive heart failure
  • Concurrent use of other anti-cancer agents or experimental treatments
  • Known current or prior autoimmune disease with the exception of vitiligo
  • Active or prior history of pneumonitis that required corticosteroids
  • Current use of supplemental oxygen
  • Is known to have received a live vaccine within 30 days prior to the first dose of trial treatment

Information from the National Library of Medicine

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): NCT03331341


Locations
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United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Ryan Lynch    206-606-1739    rclynch@uw.edu   
Principal Investigator: Ryan Lynch         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Ryan Lynch Fred Hutch/University of Washington Cancer Consortium
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT03331341    
Other Study ID Numbers: 9805
NCI-2017-01718 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9805 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
RG1001581 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: September 22, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Doxorubicin
Liposomal doxorubicin
Pembrolizumab
Dacarbazine
Vinblastine
Imidazole
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators