Monoclonal Antibody CT-011 in Combination With Rituximab in Patients With Relapsed Follicular Lymphoma

NCT00904722 | Completed Phase 2 Results DMC

• 2 other identifiers: 2009-0163NCI-2011-03225
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to learn if the combination of the immunotherapy drugs, CT-011 and rituximab, can help control follicular lymphoma. The safety of this drug combination will also be studied.

Conditions

Lymphoma

Keywords

Follicular lymphoma; Immunotherapy; CT-011; Monoclonal Antibody CT-011; Rituximab; Rituxan

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  Overall response (OR) rate defined as complete response (CR) + partial response (PR). CR: Complete disappearance of all detectable clinical evidence of disease and symptoms if present before therapy. If a PET scan was positive before therapy, a post-treatment residual mass of any size was deemed a complete response provided that it was PET negative. If response was determined by CT scan criteria, lymph nodes that regressed to less than 1·5 cm were deemed to be complete response. The spleen and/or liver, if considered enlarged before therapy should not be palpable on physical examination and be considered normal size by imaging studies, and nodules related to lymphoma should disappear. PR: At least a 50% decrease in sum of the product of the diameters (SPD) of up to six of the largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by ≥ 50% in their SPD. No new sites of disease should be observed.

  Response measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.

Secondary Outcomes (1)

• Progression-Free Survival

  Measured after completion of the second and fourth infusions of CT-011, and every 12 weeks thereafter for 2 years or until relapse.

Study Arms (1)

CT-011 in combination with Rituximab

EXPERIMENTAL

Combination of the immunotherapy drugs, CT-011 and rituximab.

Drug: CT-011; Drug: Rituximab

Interventions

CT-011 DRUG

Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days).

Also known as: Monoclonal Antibody CT-011

CT-011 in combination with Rituximab

Rituximab DRUG

Administered intravenously at the standard dose of 375 mg/m\^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).

Also known as: Rituxan

CT-011 in combination with Rituximab

Eligibility Criteria

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

You may qualify if:

• Patients with histologic proof of follicular lymphoma grade 1 or grade 2 relapsing after at least 1 but no more than 4 prior systemic therapies.Patients may have had prior local radiation therapy in addition to up to 4 prior systemic therapies. History of total body irradiation will be considered as prior systemic therapy.
• If patient received prior rituximab-based therapy, should have rituximab sensitive disease defined as a complete or partial response of at least 6 months duration with the rituximab-based regimen.
• Patients must be \>= 18 years of age.
• Should have measurable (\>= 1.5 cm) disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• At least 4 weeks from last chemotherapy, immunotherapy, radiation therapy, monoclonal antibody therapy, or experimental therapy and must have recovered from acute toxic effects of prior therapy.
• Absolute neutrophil count \>= 1.5 × 10\^9/L.
• Platelets \>= 50 × 10\^9/L.
• Absolute lymphocyte count \>= 0.6 × 10\^9/L.
• Adequate renal function with creatinine \<= 1.5 × the upper limit of normal (ULN).
• Adequate hepatic function with total bilirubin \<= 1.5 mg/dL; AST and ALT \<= 2.5 × ULN.
• Women of child-bearing potential (i.e., woman has not been naturally postmenopausal for at least 24 consecutive months or not surgically sterile) and sexually active men must agree to use 2 acceptable contraceptive methods during this study. One of the 2 methods of birth control must be a condom. Acceptable methods of birth control in combination with condoms include diaphragm, birth control pills, injections, intrauterine device, and/or under-the-skin implants. Men and women must agree to maintain effective contraception for up to 3 months after the last dose of drug is administered.
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

You may not qualify if:

• Patients positive for HIV, hepatitis B surface antigen, or hepatitis C antibody.
• Patients requiring concurrent immunosuppressive therapy are excluded. Inhaled or topical steroids for treating mild to moderate respiratory illnesses, allergies, skin rashes or ocular inflammations are allowed.
• History of central nervous system (CNS) lymphoma.
• Active or history of autoimmune disease except Hashimoto's thyroiditis. Patients with type I diabetes mellitus are excluded.
• Active infection or other serious intercurrent medical illness
• New York Heart Association Class III or IV disease.
• Pregnant or nursing.
• History of allogeneic stem cell transplantation.
• Other concurrent chemotherapy, radiotherapy, immunotherapy, or investigational therapy
• Any other malignancy except basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ treated with curative intent. Any cancer from which the patient has been disease free for at least 5 years is permissible.
• Any underlying medical condition which, in the Principal Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• CureTech Ltd: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Westin JR, Chu F, Zhang M, Fayad LE, Kwak LW, Fowler N, Romaguera J, Hagemeister F, Fanale M, Samaniego F, Feng L, Baladandayuthapani V, Wang Z, Ma W, Gao Y, Wallace M, Vence LM, Radvanyi L, Muzzafar T, Rotem-Yehudar R, Davis RE, Neelapu SS. Safety and activity of PD1 blockade by pidilizumab in combination with rituximab in patients with relapsed follicular lymphoma: a single group, open-label, phase 2 trial. Lancet Oncol. 2014 Jan;15(1):69-77. doi: 10.1016/S1470-2045(13)70551-5. Epub 2013 Dec 11.

  PMID: 24332512 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular

Interventions

pidilizumab; Rituximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Sattva S. Neelapu, MD/Associate Professor, Lymphoma/Myeloma
• Organization: The University of Texas (UT) MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

Study Officials

• Sattva S. Neelapu, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2009
• First Posted: May 20, 2009
• Study Start: January 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 3, 2016
• Results First Posted: June 3, 2016

Record last verified: 2016-04

Locations

US (1)