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Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment (LYTPET)

Primary Purpose

Lymphoma, Non-Hodgkin, Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Cyclophosphamide

Doxorubicin

Vincristine

Prednisone

Ondansetron

Dexamethasone

Diphenhydramine

Acetaminophen

Ifosfamide

Mesna (IV)

Mesna (oral)

Carboplatin

Etoposide

Rituximab

Ondansetron

Dexamethasone

Diphenhydramine

Acetaminophen

PET Scan

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring NON-HODGKIN'S LYMPHOMA, POSITRON EMISSION TOMOGRAPHY, PET, DLBCL, R-CHOP, R-ICE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 years of age or older newly diagnosed histologically proven CD-20 positive diffuse large B- cell lymphoma by tissue biopsy, listed under peripheral B-cell neoplasm according to the WHO/REAL classification (diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, T-cell rich B-cell lymphoma, intravascular large B-cell lymphoma) Advanced stage disease defined as - patients with stage III or stage IV disease; or patients with stage I or stage II disease with one of the following additional criteria: B-symptoms, or disease that is not radio- encompassable within a single involved field, or not a candidate for brief chemotherapy and irradiation, or the presence of bulky disease (any single mass => 10 cm) Previously untreated or treated with up to 3 cycles of standard dose 3- weekly R-CHOP chemotherapy prior to enrollment (i.e. patients may be enrolled prior to initiation of the fourth cycle of R-CHOP chemotherapy) ECOG Performance Status 0,1 or 2 at time of enrollment No evidence of progressive disease while on R-CHOP chemotherapy The patient must sign the consent form prior to registration Exclusion Criteria: Patients with a history of any other lymphoproliferative disorder, including prior history of indolent NHL Patients with a history of prior or concurrent malignancies within 5 years of the current diagnosis, except adequately treated non- melanoma skin cancer, and curatively treated in-situ cancer of the cervix Known HIV infection Known hepatitis B virus infection Pregnancy or lactation. Men and women of childbearing age must be using adequate contraception. Significant renal insufficiency (serum creatinine > 200 mmol/L), unless due to lymphoma Significant hepatic insufficiency (serum total bilirubin > 30 mmol/L), unless due to lymphoma Cardiac contraindication to doxorubicin therapy (e.g. abnormal contractility on echocardiography). If history of cardiac disease, ejection fraction must be within normal limits for age. Neurologic contraindication to vincristine (e.g. peripheral neuropathy) Absolute neutrophil count <1.5 x 109/L (unless due to bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy) Platelet count < 100 x 109/L (unless due to splenomegaly, bone marrow involvement with lymphoma or due to initiation of R-CHOP chemotherapy) Evidence of active systemic infection Any medical condition that in the opinion of the investigator would compromise treatment delivery, add toxicity or impair assessment

Sites / Locations

BC Cancer Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

R-CHOP (Negative Mid-Treatment PET Scan)

R-ICE (Positive Mid-Treatment PET Scan

Arm Description

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a negative mid-treatment PET scan (no evidence of abnormal 18F-FDG uptake) will complete therapy with two additional cycles of R-CHOP for a total of 6 cycles of chemotherapy. Patients with a mid-treatment PET scan interpreted to be "indeterminate" or "equivocal" will be recorded as such, but should be considered negative for the purpose of treatment planning and should not prompt a change in therapy.

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a mid-treatment PET scan (abnormal 18F-FDG uptake) will be switched to R-ICE chemotherapy and receive 4 cycles of R-ICE for a total of 8 cycles of chemotherapy. Following completion of R-ICE chemotherapy, patients will undergo a post-treatment PET scan along with routine restaging investigations. The post-treatment PET scan will be performed between days 28 and 35 following the final cycle of R-ICE. Patients with a negative post-treatment PET scan will undergo no further therapy. Patients with a positive post-treatment PET scan corresponding to persistent abnormalities on CT scan will be considered for radiation therapy to PET positive sites.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) in participants with advanced stage DLBCL

Progression-free survival (PFS) in participants with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy. Progression-free survival is defined as the duration of time from diagnosis to time of disease progression or death from any cause. Living patients who have remained free of progression will have their PFS censored on the date last known alive.

Secondary Outcome Measures

Overall survival (OS) in participants with advanced stage DLBCL

Overall survival (OS) in participants with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy. Overall survival will be defined as the time from diagnosis to the date of death. If the participant is lost to follow-up, survival will be censored on the last date the participant was known to be alive.

The safety of R-ICE therapy in first-line therapy of DLBCL following four cycles of R-CHOP as assessed using the NCI Common Terminology Criteria for Adverse Events Version 3.0

Investigate clinical and biologic markers that characterize participant heterogeneity and may serve as predictors of response to therapy and overall outcome.

A central pathology review of original diagnostic biopsies will be performed by pathologists at the Coordinating Center to ensure appropriate lymphoma subclassification. This centralized review is not required prior to enrollment, provided the patients biopsy has been carefully reviewed by local pathologists and determined to be DLBCL. Correlative studies of biologic markers will be performed on cases with adequately preserved tissue to explore the biologic heterogeneity between patients and to investigate determinants of response to therapy.

Efficacy of tailoring first-line therapy bases on a mid-treatment PET scan result for patients with advanced stage DLBCL

All patients will have their BEST RESPONSE on study classified as outlined below. For patients with more than six measurable lesions the six most distinctly measurable at diagnosis should be chosen for response assessment by CT scanning. If available, lesions from both above and below the diaphragm should be chosen, at least two from each region.

Full Information

NCT ID

NCT00324467

First Posted

May 9, 2006

Last Updated

July 20, 2021

Sponsor

British Columbia Cancer Agency

Collaborators

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00324467

Brief Title

Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

Acronym

LYTPET

Official Title

Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 2006 (undefined)

Primary Completion Date

December 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

British Columbia Cancer Agency

Collaborators

Hoffmann-La Roche

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide). Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis (>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP. Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis (~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE.

Detailed Description

This is a phase II trial investigating tailoring first-line therapy for advanced stage diffuse large B-cell NHL (DLBCL) based on a mid-treatment 18F-FDG- positron-emission tomography (PET) scan result. More than half of all patients with DLBCL can be cured with 6-8 cycles of standard R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone). Patients who are not cured with R-CHOP have a very poor prognosis. This study will assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide). Objectives: To assess the efficacy of tailoring first-line therapy based on a mid- treatment PET scan result for patients with advanced stage DLBCL. To assess the progression-free survival (PFS) in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy. To assess the overall survival (OS) in patients with advanced stage DLBCL who have a negative mid-treatment PET scan and receive standard therapy with six cycles of CHOP-R and patients with a positive mid-treatment PET scan who receive four cycles of CHOP-R followed by four cycles of R-ICE chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma, Non-Hodgkin, Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma

Keywords

NON-HODGKIN'S LYMPHOMA, POSITRON EMISSION TOMOGRAPHY, PET, DLBCL, R-CHOP, R-ICE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

R-CHOP (Negative Mid-Treatment PET Scan)

Arm Type

Active Comparator

Arm Description

Arm Title

R-ICE (Positive Mid-Treatment PET Scan

Arm Type

Active Comparator

Arm Description

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a mid-treatment PET scan (abnormal 18F-FDG uptake) will be switched to R-ICE chemotherapy and receive 4 cycles of R-ICE for a total of 8 cycles of chemotherapy. Following completion of R-ICE chemotherapy, patients will undergo a post-treatment PET scan along with routine restaging investigations. The post-treatment PET scan will be performed between days 28 and 35 following the final cycle of R-ICE. Patients with a negative post-treatment PET scan will undergo no further therapy. Patients with a positive post-treatment PET scan corresponding to persistent abnormalities on CT scan will be considered for radiation therapy to PET positive sites.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

Cytoxan®, Neosar®

Intervention Description

Dose: 750 mg/m^2 Administration: IV infusion day 1 over 20-60 minutes Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17) * Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type

Drug

Intervention Name(s)

Doxorubicin

Other Intervention Name(s)

Adriamycin ®, Rubex®

Intervention Description

Dose: 50 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17) * Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type

Drug

Intervention Name(s)

Vincristine

Other Intervention Name(s)

Oncovin ®, Vincasar Pfs ®, Vincristine Sulfate, LCR, VCR

Intervention Description

Dose: 1.4 mg/m^2 Administration: IV Push day 1 Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17) * Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type

Drug

Intervention Name(s)

Prednisone

Other Intervention Name(s)

Sterapred®, Sterapred® DS, Prednisone Intensol

Intervention Description

Dose: 45 mg/m^2 Administration: IV infusion day 1 (or day 2) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4, 5*, 6* (Week 1, 4, 7, 10, 14, 17) * Cycles 5 and 6 of R-CHOP will be administered only to patients with a negative mid-treatment PET scan

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Other Intervention Name(s)

Zofran®, Zofran® ODT, Zuplenz®

Intervention Description

Premedication for R-CHOP Dose: 8 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®

Intervention Description

Premedication for R-CHOP Dose: 12 mg Route: PO Schedule: 15 min pre-CHOP chemotherapy

Intervention Type

Drug

Intervention Name(s)

Diphenhydramine

Other Intervention Name(s)

Aler-Dryl®, Benadryl®, Nytol®, Diphenhist®

Intervention Description

Premedication for R-CHOP Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Other Intervention Name(s)

Tylenol®

Intervention Description

Premedication for R-CHOP Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type

Drug

Intervention Name(s)

Ifosfamide

Other Intervention Name(s)

Ifex®, Isophosphamide

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3, over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type

Drug

Intervention Name(s)

Mesna (IV)

Other Intervention Name(s)

Mesnex®, Sodium 2-mercaptoethanesulfonate

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5000 mg/m^2 (total dose per cycle) Administration: In 3 equally divided doses IV infusion days 1,2,3 (with ifosfamide) over 2 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type

Drug

Intervention Name(s)

Mesna (oral)

Other Intervention Name(s)

Mesnex®, Sodium 2-mercaptoethanesulfonate

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 2 g Administration: PO 2h and 4h after ifosfamide infusion on days 1,2,3 Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

CBDCA

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 5 x (25+CrCl*) (maximum dose 800 mg) Administration: IV infusion day 1 over 1 hour Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23) *Carboplatin is dose via the Calvert formula with an AUC of 5, maximum dose 800 mg per cycle. Estimate Creatinine Clearance (CrCl)

Intervention Type

Drug

Intervention Name(s)

Etoposide

Other Intervention Name(s)

Etopophos®, VP-16

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 100 mg/m^2 Administration: IV infusion day 1,2,3 over 30 minutes Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

Rituxan®

Intervention Description

R-ICE Chemotherapy Schedule (cycles repeated every 3 weeks) Dose: 375 mg/m^2 Administration: IV infusion day 1 (or day 2 or day 3) over 90 minutes-8 hours Schedule: Cycle 1, 2, 3, 4 (Week 14, 16, 20, 23)

Intervention Type

Drug

Intervention Name(s)

Ondansetron

Other Intervention Name(s)

Zofran®, Zofran® ODT, Zuplenz®

Intervention Description

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®

Intervention Description

Premedication for R-ICE Dose: 8 mg Route: PO Schedule: 15 min pre-chemotherapy daily

Intervention Type

Drug

Intervention Name(s)

Diphenhydramine

Other Intervention Name(s)

Aler-Dryl®, Benadryl®, Nytol®, Diphenhist®

Intervention Description

Premedication for R-ICE Dose: 50 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type

Drug

Intervention Name(s)

Acetaminophen

Other Intervention Name(s)

Tylenol®

Intervention Description

Premedication for R-ICE Dose: 650 mg Route: PO Schedule: Prior to rituximab and then q 4h during rituximab infusion

Intervention Type

Other

Intervention Name(s)

PET Scan

Other Intervention Name(s)

Positron emission tomography (PET) scan

Intervention Description

Investigations: 18F-FDG-PET scan Timing: After 4 cycles of R-CHOP (days 21-28) and after 4 cycles of R-ICE (days 28-35)

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) in participants with advanced stage DLBCL

Description

Time Frame

Estimated two years

Secondary Outcome Measure Information:

Title

Overall survival (OS) in participants with advanced stage DLBCL

Description

Time Frame

Several years

Title

The safety of R-ICE therapy in first-line therapy of DLBCL following four cycles of R-CHOP as assessed using the NCI Common Terminology Criteria for Adverse Events Version 3.0

Time Frame

Six months

Title

Investigate clinical and biologic markers that characterize participant heterogeneity and may serve as predictors of response to therapy and overall outcome.

Description

Time Frame

1 year

Title

Efficacy of tailoring first-line therapy bases on a mid-treatment PET scan result for patients with advanced stage DLBCL

Description

Time Frame

Four to six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurie H Sehn, MD

Organizational Affiliation

BC Cancer Agency - Vancouver Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

BC Cancer Agency

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 4E6

Country

Canada

12. IPD Sharing Statement

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Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

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