Dose Dense Chemotherapy and Rituximab for Young High Risk Diffuse Large B-Cell Lymphoma Patients (CRY-04)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose is to test whether dose densified chemoimmunotherapy followed by central nervous system (CNS) prophylaxis for young high risk diffuse large B-cell lymphoma (DLBCL) patients is feasible and could improve time to treatment failure and reduce the risk of CNS relapses. Six courses of rituximab-cyclophosphamide-doxorubicin-etoposide-vincristine-prednison (R-CHOEP) given in two weeks intervals with the support of G-CSF is followed by one course of high dose methotrexate (HD-MTX) and high dose cytarabine (HD-Ara-C). The results will be compared to a historical Nordic study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordic Lymphoma Group
• Collaborator: Amgen
• Treatments: Rituximab

Criteria

Inclusion Criteria:

1. Age ≥ 18 - < 65 years.

2. Histology verified according to the WHO classification and with CD20 positivity by immunhistochemistry or flow cytometry:

• Diffuse large B-cell lymphomas with subgroups except posttransplantation-, Burkitt-like- and primary CNS lymphomas and cases with leptomeningeal lymphoma involvement. Morphologically discordant lymphomas (most often follicular lymphoma and diffuse large cell B-cell lymphoma in different biopsy specimens, e.g. lymphatic gland and bone marrow) and transformed lymphomas are not to be included.

• Follicular lymphomas grade III The diagnosis made by the local pathologist of the participating centre will be accepted for registration

3. Patients in at least stage II with age adjusted IPI score of 2 or 3:

Stage III /IV and elevated LDH and/or WHO performance status 2 - 3 Stage II and elevated LDH and WHO performance status 2 - 3.

4. Previously untreated.

5. Performance status < 4 (Appendix 2).

6. Written informed consent

Exclusion Criteria:

1. Severe cardiac disease: cardiac function grade 3-4 (Appendix 2) or Left Ventricular Ejection Fraction (LVEF) < 45% (based on MUGA scintigraphy or echo Doppler cardiography).

2. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.

3. Pregnancy.

4. Men and women of reproductive potential not agreeing to use an acceptable method of birth control during treatment and for six months after completion of treatment.

5. Patients with other severe medical problems and with an expected short survival for non-lymphoma reasons.

6. Known HIV positivity.

7. Present or previous cancer except basal cell carcinoma and cervical carcinoma in situ.

8. Uncontrolled infectious disease.

9. Psychiatric or mental disorder which make the patient unable to give an informed consent and/or adhere to the protocol.