Clinical trial NCT01859819: Treatment for Advanced B-Cell Lymphoma
Official title: Reduced Burden of Oncologic Therapy in Advanced B-cell Lymphoma (REBOOT ABLY) in Children, Adolescents and Young Adults With CD20+ Mature B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diffuse Large Cell Lymphoma
Burkitt's Lymphoma
High Grade B-cell Lymphoma
Keywords: Pediatric
Lymphoma (NOT primary mediastinal B-cell lymphoma)
B-Cell---Burkitt's like
Rituximab
Liposomal ARA-C
Lead sponsor: New York Medical College
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 45
Sex: ALL
Minimum age (years): 3
Maximum age (years): 31
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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).


Eligibility criteria: 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.

Primary outcomes:
measure: To determine if disease response rate will improve with this combination of therapy.
timeFrame: 1 year
Secondary outcomes:
measure: To determine if the combination of IT Depocyte®, Rituximab and FAB Chemotherapy is safe.
timeFrame: 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Charlotte
country: United States
facility: Levine Children's Hospital
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: New York Medical College
name: Mitchell S Cairo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical City Children's Hospital, Dallas
name: Stanton Goldman, MD
role: STUDY_DIRECTOR
References:
citation: Goldman S, Barth M, Shiramizu B, Shi Q, Hochberg J, Klejmont L, Harrison L, Basso J, Chu Y, Islam H, Gerard P, Agsalda-Garcia M, Shieh T, Oesterheld J, Heym K, Kirov I, Drachtman R, Harker-Murray P, Perkins S, Miles RR, Cairo M. A dose substitution of anthracycline intensity with dose-dense rituximab in children and adolescents with good-risk mature B-cell lymphoma. Leukemia. 2021 Oct;35(10):2994-2997. doi: 10.1038/s41375-021-01256-8. Epub 2021 May 3. No abstract available.