T-Lymphocytes in Treating Patients with Active or Relapsed Hodgkin Lymphoma or Non-Hodgkin Lymphoma

Status: Active

Description

This phase I trial studies the side effects and the best dose of laboratory-treated T lymphocytes in treating patients with Hodgkin lymphoma or non-Hodgkin lymphoma that is active or has returned after a period of improvement. Giving an infusion of a person's T lymphocytes that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells.

Eligibility Criteria

Inclusion Criteria

  • PROCUREMENT: Diagnosis of Hodgkin’s or non-Hodgkin’s lymphoma: * GROUP A: ** With active disease *** In second or subsequent relapse *** In first relapse for indolent lymphoma after first line therapy for relapse *** Or first relapse if immunosuppressive chemotherapy contraindicated *** Primary refractory disease or if persistent disease after first line therapy of relapse ** Or multiply relapsed patients in remission who are at a high risk of relapse or the lymphoma is a second malignancy e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL) after failing frontline therapy OR * GROUP B: ** After autologous or syngeneic stem cell transplant (SCT) (as adjuvant therapy)
  • PROCUREMENT: Patients with life expectancy >= 6 weeks
  • PROCUREMENT: Hemoglobin (Hgb) > 8.0 (transfusions allowed)
  • PROCUREMENT: Patient able to give informed consent
  • TREATMENT: Diagnosis of Hodgkin’s or non-Hodgkin’s lymphoma: * GROUP A: ** With active disease *** In second or subsequent relapse *** In first relapse for indolent lymphoma after first line therapy for relapse *** Or first relapse if immunosuppressive chemotherapy contraindicated *** Primary refractory disease or if persistent disease after first line therapy of relapse ** Or multiply relapsed patients in remission who are at a high risk of relapse or the lymphoma is a second malignancy e.g. a Richter's transformation of CLL after failing frontline therapy OR * GROUP B: ** After autologous or syngeneic SCT (as adjuvant therapy)
  • TREATMENT: Patients with life expectancy >= 6 weeks
  • TREATMENT: Pulse oximetry of > 95% on room air in patients who previously received radiation therapy
  • TREATMENT: Patients with a Karnofsky/Lansky score of >= 50%
  • TREATMENT: Bilirubin =< 2 x upper limit of normal
  • TREATMNET: Aspartate aminotransferase (AST) =< 3 x upper limit of normal
  • TREATMENT: Hgb > 8.0 g/dL (transfusions allowed)
  • TREATMENT: Creatinine =< 2 x upper limit of normal for age
  • TREATMENT: Patients should have been off other investigational therapy for one month prior to entry in this study
  • TREATMENT: Patients should have been off conventional therapy for at least 1 week prior to entry in this study, including rituximab
  • TREATMENT: Patient able to give informed consent
  • TREATMENT: Pregnant women are excluded from this research; the male partner should use a condom; females of child-bearing potential must be willing to utilize one of the more effective birth control methods during the study unless female has had a hysterectomy or tubal ligation

Exclusion Criteria

  • PROCUREMENT: Patients with severe intercurrent infection
  • PROCUREMENT: Patients with active human immunodeficiency virus (HIV) positive at time of procurement (can be pending at the time of blood draw)
  • TREATMENT: Patients with severe intercurrent infection
  • TREATMENT: Patients receiving systemic corticosteroids
  • TREATMENT: Pregnant

Locations & Contacts

Texas

Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: Active
Contact: George Carrum
Phone: 713-441-1450
Email: gcarrum@bcm.edu
Center for Cell and Gene Therapy
Status: Active
Contact: George Carrum
Phone: 713-441-1450
Email: gcarrum@bcm.edu
Texas Children's Hospital
Status: Active
Contact: George Carrum
Phone: 713-441-1450
Email: gcarrum@bcm.edu
The Methodist Hospital System
Status: Active
Contact: George Carrum
Phone: 713-441-1450
Email: gcarrum@bcm.edu

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the safety of 2 intravenous injections of autologous tumor-associated antigen (TAA)-specific cytotoxic T-lymphocytes (CTL) in patients with Hodgkin's or non-Hodgkin's lymphoma.

II. To determine whether infusion of TAA-specific T cells targeting multiple tumor antigens has a safety profile similar to the adoptive transfer of single antigen-targeted T cells.

III. To obtain information on the expansion, persistence, and anti-tumor effects of the adoptively transferred TAA-specific CTL in patients with Hodgkin's or non-Hodgkin's lymphoma.

IV. To determine whether CTL infusions increase the spectrum of epitopes/antigens targeted by endogenous T cells (epitope spreading).

OUTLINE: This is a dose-escalation study.

ANTIGEN-ESCALATION STAGE: Patients receive autologous TAA-specific CTLs intravenously (IV) over 1-10 minutes on days 0 and 28 in the absence of disease progression or unacceptable toxicity.

DOSE-ESCALATION STAGE: Patients receive autologous TAA-specific CTLs IV over 1-10 minutes on days 0 and 14. Patients with active disease that have stable disease or a partial response at 8 weeks may receive an additional infusion every 6-8 weeks for a total of up to 6 additional doses in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up every 2 weeks for 8 weeks and then at 3, 6, 9, and 12 months.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center

Principal Investigator
George Carrum

Trial IDs

Primary ID BCM H 27471
Secondary IDs 9101, NCI-2012-00680, BCM-H-27471, CDR0000724621, NCT01556269
Clinicaltrials.gov ID NCT01333046