Treatment for Advanced B-Cell Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:3 - 31
Updated:3/15/2019
Start Date:January 2013
End Date:December 2019
Contact:Mitchell S Cairo, MD
Email:mitchell_cairo@nymc.edu
Phone:914-594-2150

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Reduced Burden of Oncologic Therapy in Advanced B-cell Lymphoma (REBOOT ABLY) in Children, Adolescents and Young Adults With CD20+ Mature B-Cell Lymphoma

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 (L-ARA-C, [Depocyt®]) and reducing the dose of anthracycline
(doxorubicin) in good risk patients with the addition of rituximab to the FAB chemotherapy
backbone (Immunochemotherapy).


Inclusion Criteria:

- 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 Criteria:

- 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).

4.2.6 Patients with serious (sepsis, pneumonia, etc..) proven or suspected infections at
diagnosis will be excluded.

4.2.7 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.
We found this trial at
5
sites
940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
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Salt Lake City, UT
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
Phone: 914-594-2150
New York Medical College The College was founded in 1860 by a group of New...
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Valhalla, NY
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Charlotte, North Carolina 28204
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Charlotte, NC
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