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Trial record 8 of 382 for:    Lymphoma AND (women OR woman OR female)

Treatment of Follicular Lymphoma With High Dose Therapy and Stem Cell Support Followed by Rituximab and Alpha Interferon

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ClinicalTrials.gov Identifier: NCT03069248
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Neil Berinstein, Sunnybrook Health Sciences Centre

Brief Summary:
This is a non-comparative, prospective, non-randomized single centre phase II clinical trial of Rituximab and alpha interferon immunotherapy following autologous stem cell transplant in patients with relapsed follicular lymphoma conducted at Toronto Sunnybrook Regional Cancer Centre/Sunnybrook and Women's Health Sciences Centre.

Condition or disease Intervention/treatment Phase
Follicular Lymphoma Drug: Rituximab Drug: Alpha Interferon Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Follicular Non-Hodgkin's Lymphoma With High Dose Therapy and Stem Cell Support Followed by Consolidative Immunotherapy With Rituximab and Alpha Interferon
Actual Study Start Date : June 1, 2000
Actual Primary Completion Date : September 17, 2009
Actual Study Completion Date : September 17, 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: treatment arm

Salvage treatment with CHOP or DHAP followed by high dose therapy and stem cell support prior to consolidative immunotherapy with Rituximab and Alpha interferon.

Drug: Rituximab
Drug: Alpha Interferon



Primary Outcome Measures :
  1. Survival (Overall survival) [ Time Frame: From date of randomization until date of death or last follow-up, whichever comes first, assessed up to 116 months ]
    Overall survival

  2. Survival (Progression free survival) [ Time Frame: From date of randomization until date of relapse or disease progression, assessed up to 116 months ]
    Progression free survival


Secondary Outcome Measures :
  1. Toxicities (Possible transplant-related adverse events) [ Time Frame: assessed semi-annually, from date of enrollment up to 116 months ]
    Possible transplant-related adverse events such as secondary malignancies, hypogammaglobulinemia, and pulmonary fibrosis

  2. Minimal Residual Disease [ Time Frame: assessed semi-annually, from date of enrollment up to 116 months ]
    Occult disease by PCR analysis of the t(14;18) or of patient specific V(D)J rearrangements in peripheral blood, bone marrow and stem cell graft collections.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with 1-2 relapses of WHO Classification follicle centre NHL grade 1-2/3. Patients must have achieved at least a PR to previous treatment.
  • Central pathology review before registration
  • Ann Arbor stage III or IV
  • Measurable disease: defined as clinically or radiologically documented disease with at least one site bidimensionally measurable using clinical exam, CT or MRI performed in the 3 weeks prior to study enrollment.
  • ECOG performance status of <2.
  • Patients may have received not more than 1 prior course (4 infusions) of rituximab. Timing of rituximab must exceed 12 months prior to registration. Patients must have demonstrated at least a PR to rituximab if previously administered.
  • Patient consent according to institutional and university human experimentation committee requirements
  • Adequate Renal, hepatic and hematopoietic function test unless the abnormal values are thought to be due to involvement with lymphoma as defined by:

Hb> 85 ANC >1000/mm3 Platelets >100,000/mm3 Serum/Total Bilirubin >=2 SI units AST/ALT <2x Upper Limit of Normal

Exclusion Criteria:

  • Positive serology for HIV
  • Uncontrolled Infection
  • Pregnancy
  • CNS Metastases
  • History of Psychiatric Disorder
  • Other Malignancy (except nonmelanoma skin cancer)
  • Serious non-malignant disease (e.g., congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections), or other conditions, which, in the opinion of the investigator and/or the sponsor, would compromise other protocol objectives.
  • Major surgery, other than diagnostic surgery, within four weeks.
  • Presence of anti-murine antibody (HAMA) reactivity. These laboratory results must be available prior to receiving treatment for those patients
  • who have received prior murine proteins or patients who have allergies to murine proteins.
  • New York Heart Association Class III or IV heart disease (see Appendix H, Clinical Evaluation of Functional Capacity of Patients with Heart Disease in Relation to Ordinary Physical Activity) or myocardial infarction within the past six months.
  • Treatment with an investigational drug within 30 days or five half-lives (of the study drug with the longest half-life) prior to entry into the study, which ever is longer.
  • Previous chemotherapy, immunotherapy, radiotherapy, or investigational therapy for the treatment of other malignancy except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix within the last 5 years.
  • History of allergic reactions to compounds chemically related to Rituximab.
  • Refusal to practice contraception if of reproductive potential.

Information from the National Library of Medicine

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): NCT03069248


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre, Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Neil Berinstein, MD Sunnybrook Health Sciences Centre

Responsible Party: Dr. Neil Berinstein, Principal Investigator, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03069248     History of Changes
Other Study ID Numbers: 089-2000
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Interferons
Interferon-alpha
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antiviral Agents
Anti-Infective Agents