Study of Rituximab and Brentuximab Vedotin for Relapsed Classical Hodgkin Lymphoma

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT01900496
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Brentuximab vedotin — BIOLOGICAL
    Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.
  • Rituximab — BIOLOGICAL
    Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m\^2 IV. Additional doses are given at three and six months post week 27.

Study Details

This research is being done to study a combination of Brentuximab vedotin and Rituximab for the treatment of relapsed Hodgkin's Lymphoma (HL).

Key Dates

Start date
Jun 30, 2014
Status verified
Oct 2018
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Brentuximab vedotin & Rituximab
    Brentuximab vedotin: Will be administered at 1.8 mg/kg IV over 30 minutes is given for up to 10 doses (cycles), with a cycle length of 21 days. Brentuximab vedotin is first given on day 1 of cycles 1, 2, 3, and 4 as a single agent (weeks 0, 3, 6, and 9, respectively). Four cycles are chosen because of the 12-week median time to CR in the pivotal phase 2 trial of brentuximab vedotin after autologous BMT for HL. Brentuximab vedotin will be administered with Rituximab at 375 mg/m2 IV is given for up to 8 "induction" doses: day 1 of week 6, 7, 8, and 9; day 1 of week 12, 15, 18 and 21. This is followed by rituximab "maintenance" (375 mg/m2 IV once every 3 months x 2 doses) to complete a \~ 1 year total course of therapy.

Primary Outcome Measure

Failure-free survival [ Time Frame: Up to 7 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Sidney Kimmel Comprehensive Canceer CenterBaltimoreMaryland21287-

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By research site
The Sidney Kimmel Comprehensive Canceer Center· Baltimore, MD

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