Risk Adapted Therapy in Diffuse Large B Cell Lymphoma

NCT03188198 | Unknown Phase 2

• 1 other identifier: mans lymphoma1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Response rate

  one year post-registration

Secondary Outcomes (1)

• Event-free survival

  Up to 3 years post-registration

Study Arms (2)

Arm A - R-CHOP

ACTIVE COMPARATOR

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

Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim

Arm B - DA-EPOCH-R

EXPERIMENTAL

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

Drug: rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim

Interventions

rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim DRUG

Also known as: rituximab:mabthera, etoposide:vepsid, cyclophosphamide:endoxan, doxorubcin:adriamycin

Arm A - R-CHOP; Arm B - DA-EPOCH-R

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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).
• \. 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%.
• \. 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)

You may not qualify if:

• Patients with an underlying low-grade lymphoma, such as a transformed lymphoma or low-grade lymphoma in the bone marrow, are not eligible.
• 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.
• 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.
• 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.
• 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.
• Patients with active medical processes (e.g., uncontrolled bacterial or viral infection, bleeding) not related to their lymphoma should be excluded.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Oncology center

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Interventions

Rituximab; Etoposide; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone; Filgrastim

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Central Study Contacts

Ahmed Eltantawy, Master

CONTACT

00201091203484; eltantawy.ahmed1@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 20, 2017
• First Posted: June 15, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: July 6, 2017

Record last verified: 2017-06

Locations

EG (1)