Status:
COMPLETED
Treatment for Advanced B-Cell Lymphoma
Lead Sponsor:
New York Medical College
Conditions:
Diffuse Large Cell Lymphoma
Burkitt's Lymphoma
Eligibility:
All Genders
3-31 years
Phase:
PHASE2
Brief Summary
To safely reduce the burden of therapy in children, adolescents and young adults with mature B-NHL by reducing the number of intrathecal (IT) injections by the introduction of IT Liposomal Cytarabine ...
Eligibility Criteria
Inclusion
- Newly diagnosed mature B-lineage (CD20 positive) Leukemia/Lymphoma
- 1\. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2. Burkitt's Lymphoma
- 3\. High Grade B-cell Lymphoma---Burkitt's like.
- B-Cell Anaplastic Large cell Ki 1 positive lymphomas, Primary Mediastinal B-Cell Lymphoma (PMBL), and B-Lymphoblastic lymphomas are ineligible.
- No previous chemotherapy. Patients who have received emergency irradiation and/or steroid therapy will be eligible ONLY if started on protocol therapy not more than 72 hours from the start of radiotherapy or steroids. Bone marrow and cerebrospinal fluid MUST be obtained before steroids are given for patient to be eligible for the study.
Exclusion
- Patients with newly diagnosed Group A (low risk) lymphoma. Patients with Group B (intermediate risk) if classified as Murphy Stage III/IV and diagnostic LDH \> 2 XULN and patients with primary mediastinal B-cell lymphoma (PMBL).
- Patients who have received any steroids in the week prior to diagnosis except as stated in Section 4.1.4 of the protocol.
- No congenital or acquired immune deficiency. These patients are excluded due to the expected intense immunosuppression, increased risk of opportunistic infections, and higher expected septic death rate in this subgroup of patients with this proposed therapy.
- No prior solid organ transplantation.
- Patients with previous malignancies that have been treated with systemic chemotherapy with alkylator or anthracycline therapy. The latter group of patients are excluded due to an expected increase in late effects (eg. late cardiac toxicity, secondary malignancies, sterility, etc.).
- Patients with known G6PD deficiency are NOT ELIGIBLE for Rasburicase therapy. Patients with G6PD deficiency should be treated with alkalinization, IV hydration and po and/or IV allopurinol during the reduction phase (COP).
- 2.6 Patients with serious (sepsis, pneumonia, etc..) proven or suspected infections at diagnosis will be excluded.
- 2.7 Pregnancy or Breast-Feeding: No information is available regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01859819
Start Date
January 1 2013
End Date
June 1 2021
Last Update
October 25 2022
Active Locations (5)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
2
New York Medical College
Valhalla, New York, United States, 10595
3
Levine Children's Hospital
Charlotte, North Carolina, United States, 28204
4
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104