A Study of Safety and Efficacy of Nivolumab and Bendamustine (NB) in Patients With Relapsed/Refractory Hodgkin's Lymphoma (NB001)
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|ClinicalTrials.gov Identifier: NCT03343652|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : April 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hodgkin's Lymphoma||Drug: Nivolumab Drug: Bendamustine Hydrochloride||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Clinical Trial to Evaluate the Safety and Efficacy of Nivolumab and Bendamustine Combination (NB) in Patients With Relapsed or Refractory Hodgkin's Lymphoma|
|Actual Study Start Date :||May 27, 2017|
|Actual Primary Completion Date :||March 27, 2019|
|Estimated Study Completion Date :||March 27, 2020|
Nivolumab 3 mg/kg IV infusion on day 1,14 + Bendamustine hydrochloride 90 mg/kg IV infusion on day 1,2 up to 3 cycles. Duration of cycle 28 days
3 mg/kg IV infusion on day 1,14 up to 3 cycles
Other Name: Opdivo
Drug: Bendamustine Hydrochloride
90 mg/kg IV infusion on day 1 up to 3 cycles
Other Name: Ribomustin
- Overall Response Rate (ORR) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma [ Time Frame: up to 3 months ]Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response.
- Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 [ Time Frame: up to 12 months ]Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).
- Duration of Response (DOR) [ Time Frame: up to 12 months ]Duration of response will be measured from the time of initial response to nivolumab till documented disease progression, death or last evaluation of tumor status.
- Time to Progression (TTP) [ Time Frame: up to 12 months ]
- Progression-Free Survival (PFS) [ Time Frame: up to 12 months ]
- Overall Survival (OS) [ Time Frame: up to 12 months ]
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): NCT03343652
|First Pavlov State Medical University of St. Petersburg|
|Saint-Petersburg, Russian Federation, 197089|
|Study Director:||Boris V Afanasyev, PhD||First Pavlov State Medical University of St. Petersburg|