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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

Phase 2
3 Years
31 Years
Open (Enrolling)
Diffuse Large Cell Lymphoma, Burkitt's Lymphoma, High Grade B-cell Lymphoma

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if disease response rate will improve with this combination of therapy.

Outcome Description:

To determine if the addition of intrathecal ([IT] [Depocyt®]) and reduction of standard IT dosing and the reduction of anthracycline exposure (doxorubicin) (60%) within the ANHL01P1 FAB/LMB B4 + Rituximab chemoimmunotherapy backbone in children, adolescents and young adults with good risk CD20+ mature B-NHL (Stage I and II unresected and Stage III/IV with LDH < 2 UNL) will result in similar response rates compared to historical controls (Subgroup I).

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Mitchell S Cairo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York Medical College


United States: Institutional Review Board

Study ID:




Start Date:

January 2013

Completion Date:

December 2017

Related Keywords:

  • Diffuse Large Cell Lymphoma
  • Burkitt's Lymphoma
  • High Grade B-cell Lymphoma
  • Pediatric
  • Lymphoma (NOT primary mediastinal B-cell lymphoma)
  • B-Cell---Burkitt's like
  • Rituximab
  • Liposomal ARA-C
  • Burkitt Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



New York Medical College Valhalla, New York  10595