A(B)VD Followed by Nivolumab as Frontline Therapy for Higher Risk Patients With Classical Hodgkin Lymphoma (HL)

Conditions

• Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• doxorubicin — DRUG
  Doxorubicin: 25 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
• Bleomycin — DRUG
  Bleomycin: 10 units/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
• vinblastine — DRUG
  Vinblastine: 6 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
• dacarbazine — DRUG
  Dacarbazine (DTIC): 375 mg/m\^2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
• Nivolumab — DRUG
  nivolumab 240mg q14 days

Study Details

The aim of this study is to improve the chance of cure for people with higher risk Hodgkin lymphoma. The purpose of the Phase I study is to test any good and bad effects of the study drug called Nivolumab when combined with ABVD for the front-line treatment of HL.The purpose of this Phase II study is to test whether including nivolumab in treatment for untreated Hodgkin lymphoma can improve the chance of cure for patients with abnormal PET scans after 2 cycles of ABVD.

Key Dates

Start date

Jan 25, 2017

Status verified

Feb 2026

Primary completion

Jan 31, 2027

Completion

Jan 31, 2027

Study Design

Enrollment

82 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: < 60 years of age with advanced stage (HL) untreated
  The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of A(B)VD and 8 doses of nivolumab. In dose level 1, patients will receive nivolumab in combination with AVD during cycle 6 only followed by 6 additional doses of nivolumab. In subsequent dose levels, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. A PET scan will be performed after 2 cycles of ABVD and those with a PET-negative response (defined by Deauville 1, 2 or 3) will proceed with 4 additional cycles of ABVD or AVD (per treating physician preference).
• Experimental: 60 years of age and older with HL (any stage) untreated
  The study will employ a 3+3 design and include 3 treatment cohorts. In each cohort, patients will receive 6 cycles of AVD and 12 doses of nivolumab. In this cohort, patients will receive nivolumab in combination with AVD during cycles 5 and 6 only, followed by 8 additional doses of nivolumab. In subsequent cohorts, nivolumab will be combined with increasing numbers of cycles of AVD. Based upon safety data from another study with Nivolumab, we will no longer need to evaluate dose level 2. If we determine that dose level 1 is safe, the next group of patients will enroll onto dose level 3. Prophylactic growth factor support is mandatory for all patients on Cohort B and should be used per the treating physician's discretion for all other patients.

Primary Outcome Measure

number of patients who have dose limiting toxicity [ Time Frame: 2 years ]

Locations (9)

Find similar trials in Detroit, MI

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