R-ICE and Lenalidomide in Treating Patients With First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Academic and Community Cancer Research United
Study ID
NCT02628405
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Recurrent Transformed Non-Hodgkin Lymphoma
  • Refractory B-Cell Non-Hodgkin Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Lymphoma
  • Refractory Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Ifosfamide — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Lenalidomide — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and to see how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement (relapsed) and that has not responded to previous treatment (refractory). Drugs used in chemotherapy, such as rituximab, ifosfamide, carboplatin, etoposide, and lenalidomide, 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. Giving lenalidomide with R-ICE may be a better treatment for patients with diffuse large B-cell lymphoma.

Key Dates

Start date
May 20, 2016
Status verified
Jun 2024
Primary completion
Sep 24, 2021
Completion
Dec 20, 2025

Study Design

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

Arms

  • Experimental: Treatment (R2-ICE)
    Patients receive lenalidomide PO daily on days 1-14, rituximab IV on day 1, ifosfamide IV over 24 hours on day 2, carboplatin IV over 1-2 hours on day 2, and etoposide IV over 1 hour on days 1-3. Treatment repeats every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving CMR, PMR, or NMR may receive 2 more cycles per physician discretion. After completion of 2 cycles of R2ICE treatment, patients achieving objective status of CMR, PMR or NMR may proceed to SCT during the event monitoring phase.

Primary Outcome Measure

Overall Response Rate (Phase II) [ Time Frame: At 42 days (after 2 courses) of treatment ]

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Carle Cancer Center NCI Community Oncology Research ProgramUrbanaIllinois61801-
University of Iowa/Holden Comprehensive Cancer CenterIowa CityIowa52242-
Siouxland Regional Cancer CenterSioux CityIowa51101-
Mayo Clinic in RochesterRochesterMinnesota55905-
Coborn Cancer Center at Saint Cloud HospitalSaint CloudMinnesota56303-
Metro Minnesota Community Oncology Research ConsortiumSaint Louis ParkMinnesota55416-
Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanonNew Hampshire03756-
Hackensack University Medical CenterHackensackNew Jersey07601-
State University of New York Upstate Medical UniversitySyracuseNew York13210-
Rapid City Regional HospitalRapid CitySouth Dakota57701-
Marshfield Medical Center-MarshfieldMarshfieldWisconsin54449-

Find similar trials in Jacksonville, FL

By research site
Mayo Clinic in Florida· Jacksonville, FLCarle Cancer Center NCI Community Oncology Research Program· Urbana, ILUniversity of Iowa/Holden Comprehensive Cancer Center· Iowa City, IASiouxland Regional Cancer Center· Sioux City, IAMayo Clinic in Rochester· Rochester, MNCoborn Cancer Center at Saint Cloud Hospital· Saint Cloud, MN

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