Lenalidomide Therapy After Chemotherapy & Stem Cell Transplant in Treating Chemotherapy Resistan Non-Hodgkin Lymphoma

Part of paid clinical trials in Westwood, Kansas.

Sponsor
University of Nebraska
Study ID
NCT01035463
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Anaplastic Large Cell Lymphoma, ALK-Negative
  • Recurrent Anaplastic Large Cell Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
  • Recurrent Non-Hodgkin Lymphoma
  • Recurrent Transformed Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • Autologous Hematopoietic Stem Cell Transplantation — PROCEDURE
    Undergo autologous hematopoietic stem cell transplant
  • Carmustine — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Lenalidomide — DRUG
    Given PO
  • Melphalan — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV

Study Details

This phase I/II trial studies the side effects and best dose of lenalidomide when given after combination chemotherapy with or without rituximab and stem cell transplant and to see how well it works in treating patients with non-Hodgkin lymphoma that has not responded to treatment or has returned after a period of improvement and is resistant to chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth by targeting certain cells. Giving lenalidomide after combination chemotherapy with or without rituximab may work better in treating patients with non-Hodgkin lymphoma.

Key Dates

Start date
Nov 12, 2009
Status verified
Sep 2023
Primary completion
Jul 27, 2017
Completion
Jul 27, 2018

Study Design

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

Arms

  • Experimental: Treatment (stem cell transplantation)
    PRE-CONDITIONING (patients with CD20+ NHL): Patients receive rituximab IV per standard of care. PREPARATIVE REGIMEN: Patients receive carmustine IV on day -6, etoposide IV BID and cytarabine IV BID on days -5 through -2, and melphalan IV on day -1. AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION: Patients undergo stem cell infusion on day 0. MAINTENANCE THERAPY: Beginning approximately 100 days post-transplant, patients receive lenalidomide PO on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose of Lenalidomide (Phase I) [ Time Frame: Cycle 1, 28 days ]

Locations (3)

FacilityCityStateZIPSite coordinators
University of Kansas Hospital-Westwood Cancer CenterWestwoodKansas66205-
University of Nebraska Medical CenterOmahaNebraska68198-
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterClevelandOhio44106-

Find similar trials in Westwood, KS

By research site
University of Kansas Hospital-Westwood Cancer Center· Westwood, KSUniversity of Nebraska Medical Center· Omaha, NESeidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center· Cleveland, OH

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