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

NCT03069248 | Completed Phase 2 FDA Drug

• 1 other identifier: 089-2000
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• Survival (Overall survival)

  Overall survival

  From date of randomization until date of death or last follow-up, whichever comes first, assessed up to 116 months

• Survival (Progression free survival)

  Progression free survival

  From date of randomization until date of relapse or disease progression, assessed up to 116 months

Secondary Outcomes (2)

• Toxicities (Possible transplant-related adverse events)

  assessed semi-annually, from date of enrollment up to 116 months

• Minimal Residual Disease

  assessed semi-annually, from date of enrollment up to 116 months

Study Arms (1)

treatment arm

EXPERIMENTAL

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

Interventions

Rituximab DRUG

treatment arm

Alpha Interferon DRUG

treatment arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre, Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Rituximab; Interferon-alpha

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Neil Berinstein, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 3, 2017
• Study Start: June 1, 2000
• Primary Completion: September 17, 2009
• Study Completion: September 17, 2009
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)