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This was a single center, single arm, phase II study. Patients with previously untreated follicular lymphoma were enrolled from the department of lymphoma, Tianjin Medical University Cancer Institute and Hospital. The bulky disease was received radiation (dose:18~24Gy) before RCHOP. Patients began chemoimmunotherapy 1~2 weeks later than radiation. Treatment included Tiselizumab (200 mg iv d1) plus R-CHOP (rituximab 375 mg/m2 intravenous [IV] day 2, cyclophosphamide 750 mg/m2 IV day 3, doxorubicin 50 mg/m2 IV day 3, vincristine 1.4 mg/m2 [maximum 2.0 mg total] IV day 3, and prednisone 100 mg oral days 3-7, 21~28 days for one cycle ) for six cycles. Rituximab was given every 2 months to patients who were complete metabolic response /partial metabolic response(CMR/PMR)after first-line chemo until 2 years. Response was assessed by PET/CT scan after cycle 4 and cycle 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Treatment arm | Experimental | Radiation (dose:18~24Gy) ,chemoimmunotherapy 1~2 weeks later than radiation. Tiselizumab (200 mg iv d1) R-CHOP (rituximab 375 mg/m2 intravenous [IV] day 2, cyclophosphamide 750 mg/m2 IV day 3, doxorubicin 50 mg/m2 IV day 3, vincristine 1.4 mg/m2 [maximum 2.0 mg total] IV day 3, and prednisone 100 mg oral days 3-7, 21~28 days for one cycle ) for six cycles. Rituximab was given every 2 months to patients who were complete metabolic response /partial metabolic response(CMR/PMR)after first-line chemo until 2 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation | received radiation (dose:18~24Gy) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Best Complete response (CR) rate | Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria | Through completion of treatment (estimated to be 2.5 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Best overall response rate (ORR) | Objective Response rate will be determined on the basis of investigator assessments according to 2014 Lugano criteria. | Through completion of treatment (estimated to be 2.5 year) |
| 2 year progression-free survival |
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Inclusion Criteria:
Histologically confirmed CD20 positive (+) follicular lymphoma, grade 1, 2, or 3a,bulky disease (Mass diameter ≥ 7 cm)
Have had no prior systemic treatment for lymphoma
Meeting Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria for initiation of treatment
Age 18-75 years
ECOG Performance Status of 0-2 .Stage II, III, or IV by Ann Arbor staging system.
Demonstrate adequate organ function as defined below; all screening labs to be obtained within 28 days prior to registration.
Females of childbearing potential must be willing to abstain from vaginal intercourse or use an effective method(s) of contraception from the time of informed consent, during the study and for 6 months after the last dose of study drug(s). Males able to father a child must be willing to abstain
Life expectancy ≥6 months
Sign (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including biomarkers, and are willing to participate in the study
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huilai Zhang, MD,PhD | Contact | 02223359337 | 18526812877@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tiselizumab |
| Drug |
200 mg iv day 1 |
|
| Rituximab | Drug | 375 mg/m2 intravenous [IV] day 2 |
|
| Cyclophosphamide | Drug | 750 mg/m2 IV day 3 |
|
| Doxorubicin | Drug | 50 mg/m2 IV day 3 |
|
| Vincristine | Drug | 1.4 mg/m2 [maximum 2.0 mg total] IV day 3 |
|
| Prednisone | Drug | 100 mg oral days 3-7 |
|
The date of enrollment until disease progression or death from any cause.
| From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years |
| Percentage of Participants With Adverse Events | Adverse Events will be determined and graded on the basis of investigator assessments according to NCI CTC AE 5.0 | Up to 30 days after completion of study treatment |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D000069283 | Rituximab |
| D003520 | Cyclophosphamide |
| D004317 | Doxorubicin |
| D014750 | Vincristine |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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