Rituximab-HyperCVAD (R-HCVAD) Alternating With Rituximab-Methotrexate-Cytarabine- (R-MC) in Newly Diagnosed Patients With Diffuse Large B-Cell Lymphoma With MYC-Rearrangement.
NCT ID: NCT01854372
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2013-06-30
2013-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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R-HCVAD and R-MC Chemotherapy
R-HCVAD - Rituximab (375 mg/m2), Cyclophosphamide (300 mg/m2), Mesna (600 mg/m2), Doxorubicin (50 mg/m2), Vincristine (2 mg total), Dexamethasone (40 mg total), Methotrexate (12 mg), Cytarabine (100mg).
R-MC -Rituximab (375 mg/m2),Methotrexate (200 mg/m2 - 800mg/m2), Cytarabine (3000mg/m2), Leucovorin (15mg - 50mg).
R-HCVAD and R-MC
Interventions
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R-HCVAD and R-MC
Eligibility Criteria
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Inclusion Criteria
2. Positivity for MYC-R by Fluorescent in-situ Hybridization (FISH) or by classical cytogenetics.
3. No prior lymphoma treatment, with one exception: One cycle of R-CHOP regimen is permitted (consisting of one single dose each of Rituximab, of cyclophosphamide, of doxorubicine, and of vincristine, as well as up to 5 doses of Prednisone when part of chemotherapy).
4. No prior radiation therapy is permitted
5. Age ≥ 18 years to 70 years of age
6. CT imaging of neck, chest, abdomen and pelvis within 28 days prior to registration. Any additional imaging used to assess extent of disease must also have been done within 28 days prior to registration
7. Bidimensionally measurable disease by imaging within 28 days prior to registration
8. Adequate bone marrow biopsy, and aspiration performed for staging within 28 days before registration, and before start of any treatment
9. Indication for primary treatment with systemic multiagent chemotherapy
10. Creatinine ≤ 2.0 mg/dL and estimated (Cockroft-Gault) creatinine clearance\> 50 ml/min within 7 days prior to registration
11. Cardiac ejection fraction of ≥ 50% by MUGA scan or by 2-D echocardiogram , as well as EKG without significant abnormality within 28 days prior to registration
12. Performance status of 0, of 1, or of 2 (ECOG scale)
13. Patient willing to have, and to maintain, a central venous line throughout the treatment phase (either PICC line, or double lumen tunnelled catheter, or double lumen subcutaneous venous port system)
14. Willing and logistically able to be followed as outpatient at least twice weekly, during the treatment phase.
15. Signed informed consent to accept transfusion of blood products as medically indicated
16. Signed informed consent to participate in this trial
Exclusion Criteria
2. Leukemic presentation, or no evidence of disease by imaging
3. Unwilling to be screened for HIV. HIV positive patients must receive combined antiretroviral treatment while on study. They are excluded from participation unless they show a CD4 count \>250/uL and a viral load \< 50 within 28 days of registration.
4. Hepatic involvement and total serum bilirubin ≥ 5 mg/dL within 7 days prior to registration, or total serum bilirubin ≥ 1.6 mg/ dL without hepatic involvement within 7 days prior to registration
5. Patients with bone marrow involvement and either ANC \< 1000/uLor Platelets \< 50,000/uL, within 7 days before registration
6. Patients without bone marrow involvement by lymphoma, and either ANC \< 1500/uL or Platelets \< 100,000/uL within 7 days before registration
7. Patients with myelodysplastic syndrome, with sickle cell disease, or with transfusion dependence for over 6 months antedating the diagnosis oflymphoma.
8. Known hypersensitivity to E. coli derived proteins
9. Patients at risk of reactivation of hepatitis B who are unwilling to be treated with appropriate antivirals as medically indicated.
10. Pregnant or nursing women, or any patient with reproductive potential and unwilling to use effective contraceptive method from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method, or total abstinence.
11. Additional or prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for \~ 5 years
12. Unwilling to receive transfusions of blood products as medically indicated
18 Years
70 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Countries
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Other Identifiers
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CTRC 11-53
Identifier Type: -
Identifier Source: org_study_id