search
Back to results

Risk Adapted Therapy in Diffuse Large B Cell Lymphoma

Primary Purpose

Large B Cell Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Large B Cell Lymphoma

Eligibility Criteria

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

Inclusion Criteria:

  • 1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease.

Stage I primary mediastinal (thymic) DLBCL is also eligible. Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy.

Needle aspiration for primary diagnosis is unacceptable.

Patients must have one of the following WHO classification subtypes:

Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic) Mediastinal (thymic) large B-cell lymphoma Intravascular large B-cell lymphoma Patients without adequate frozen material should have a biopsy performed to obtain material.

2. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids (< 10 days) for an urgent local disease complication at diagnosis (e.g., cord compression, SVC syndrome).

3. Age >16 years old. 4. ECOG Performance Status 0-2 5. If there is suspicion of cardiac disease, a cardiac ejection fraction must show LVEF > 45%.

6. Required Initial Laboratory Values (unless non-Hodgkin lymphoma):

  • ANC ≥ 1000/μL
  • Platelets ≥ 100,000/μL
  • Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min
  • Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease)

Exclusion Criteria:

  • 1- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.

    2- Patients with low international prognostic index are not eligible. 3- Prior cytotoxic chemotherapy or rituximab. Patients who have received chemotherapy for prior malignancies are not eligible.

    4- Active ischemic heart disease or congestive heart failure. 5- Known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms.

    6- Known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible.

    7- Pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception.

    8- Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.

Sites / Locations

  • Oncology centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A - R-CHOP

Arm B - DA-EPOCH-R

Arm Description

Patients receive the following treatment:Rituximab 375 mg/m2 IV infusion on Day 1 prior to CHOP chemotherapy.Cyclophosphamide 750 mg/m^2 IV on Day 1.Doxorubicin 50 mg/m^2 IV on Day 1.Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1.Prednisone 40 mg/m^2/day PO on Days 1-5.filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6. Interventions:-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: filgrastim-Drug: pegfilgrastim

Patients receive the following treatment: Cycle 1 Doses:Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy. Doxorubicin 10 mg/m^2/day CIVI on Days 1-4.Etoposide 50 mg/m^2/day CIVI on Days 1-4. Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours). Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions). Prednisone 60 mg/m^2 PO BID on Days 1-5 Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the nadir (nadir usually between Days 10-12) Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6. Interventions: -Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: etoposide-Drug: filgrastim

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Event-free survival

Full Information

First Posted
May 20, 2017
Last Updated
July 3, 2017
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT03188198
Brief Title
Risk Adapted Therapy in Diffuse Large B Cell Lymphoma
Official Title
Phase II Randomized Study of R-CHOP V. Dose-Adjusted EPOCH-R in Untreated De Novo Diffuse Large B-Cell Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Anticipated)
Study Completion Date
June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with diffuse large B-cell lymphoma.
Detailed Description
objectives: To compare the response rates and toxicity of R-CHOP versus DA-EPOCH-R in untreated CD20+ diffuse large B-cell lymphomas. To compare the event-free survival of R-CHOP versus DA-EPOCH-R chemotherapy in untreated CD20+ diffuse large B-cell lymphomas. To develop predictors of outcome of R-CHOP and DA-EPOCH-R chemotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Large B Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A - R-CHOP
Arm Type
Active Comparator
Arm Description
Patients receive the following treatment:Rituximab 375 mg/m2 IV infusion on Day 1 prior to CHOP chemotherapy.Cyclophosphamide 750 mg/m^2 IV on Day 1.Doxorubicin 50 mg/m^2 IV on Day 1.Vincristine 1.4 mg/m^2 IV (2 mg cap) on Day 1.Prednisone 40 mg/m^2/day PO on Days 1-5.filgrastim or pegfilgrastim as defined in the protocol Required ancillary medications is administered during all cycles as defined in the protocol. Cycles will be repeated every 21 days for 6 treatment cycles. Restaging will occur after Cycles 4 and 6. Interventions:-Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: filgrastim-Drug: pegfilgrastim
Arm Title
Arm B - DA-EPOCH-R
Arm Type
Experimental
Arm Description
Patients receive the following treatment: Cycle 1 Doses:Rituximab 375 mg/m^2 IV infusion on Day 1 prior to EPOCH chemotherapy. Doxorubicin 10 mg/m^2/day CIVI on Days 1-4.Etoposide 50 mg/m^2/day CIVI on Days 1-4. Vincristine 0.4 mg/m^2/day (no cap) CIVI on Days 1-4 (total 1.6 mg/m2 over 96 hours). Cyclophosphamide 750 mg/m^2 IV on Day 5 (following completion of 96 hour infusions). Prednisone 60 mg/m^2 PO BID on Days 1-5 Administer filgrastim 480 mcg subcutaneous daily from Day 6 until ANC > 5000 after the nadir (nadir usually between Days 10-12) Doses for subsequent cycles will be determined by the absolute neutrophil (ANC) or platelet nadir from the previous cycle. Cycles will be repeated every 21 days for a maximum of 6 cycles. Restaging will occur after Cycles 4 and 6. Interventions: -Biological: rituximab-Drug: cyclophosphamide-Drug: doxorubicin-Drug: vincristine-Drug: prednisone-Drug: etoposide-Drug: filgrastim
Intervention Type
Drug
Intervention Name(s)
rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim
Other Intervention Name(s)
rituximab:mabthera, etoposide:vepsid, cyclophosphamide:endoxan, doxorubcin:adriamycin
Primary Outcome Measure Information:
Title
Response rate
Time Frame
one year post-registration
Secondary Outcome Measure Information:
Title
Event-free survival
Time Frame
Up to 3 years post-registration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Histologically documented de novo CD20+ DLBCL with stage II, III or IV disease. Stage I primary mediastinal (thymic) DLBCL is also eligible. Diagnosis should be based on an adequate tissue sample, including open biopsy or core needle biopsy. Needle aspiration for primary diagnosis is unacceptable. Patients must have one of the following WHO classification subtypes: Diffuse large B-cell lymphoma (includes morphological variants: centroblastic, immunoblastic, T-cell/histiocyte rich, and anaplastic) Mediastinal (thymic) large B-cell lymphoma Intravascular large B-cell lymphoma Patients without adequate frozen material should have a biopsy performed to obtain material. 2. Patients may be entered if they have received prior limited field radiation therapy or a short course of glucocorticoids (< 10 days) for an urgent local disease complication at diagnosis (e.g., cord compression, SVC syndrome). 3. Age >16 years old. 4. ECOG Performance Status 0-2 5. If there is suspicion of cardiac disease, a cardiac ejection fraction must show LVEF > 45%. 6. Required Initial Laboratory Values (unless non-Hodgkin lymphoma): ANC ≥ 1000/μL Platelets ≥ 100,000/μL Creatinine≤ 1.5 mg/dL or creatinine clearance ≥ 50 cc/min Total Bilirubin ≤ 2 mg/dL (unless a history of Gilbert's Disease) Exclusion Criteria: 1- Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible. 2- Patients with low international prognostic index are not eligible. 3- Prior cytotoxic chemotherapy or rituximab. Patients who have received chemotherapy for prior malignancies are not eligible. 4- Active ischemic heart disease or congestive heart failure. 5- Known lymphomatous involvement of the CNS. A lumbar puncture prior to study is not required in the absence of neurological symptoms. 6- Known HIV disease. Patients with a history of intravenous drug abuse or any other behavior associated with an increased risk of HIV infection should be tested for exposure to the HIV virus. Patients who test positive or who are known to be infected are not eligible. 7- Pregnant and non-nursing. Treatment would expose an unborn child to significant risks. Women and men of reproductive potential should agree to use an effective form of contraception. 8- Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Eltantawy, Master
Phone
00201091203484
Email
eltantawy.ahmed1@gmail.com
Facility Information:
Facility Name
Oncology center
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Eltantawy, Master
Phone
00201091203484
Email
eltantawy.ahmed1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Risk Adapted Therapy in Diffuse Large B Cell Lymphoma

We'll reach out to this number within 24 hrs