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Recurrent Acute Lymphoblastic LeukemiaCancerDrugBiologicalPhase 2

What this study is

This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

What's being tested

  • Bortezomib

    Intervention · DRUG

  • Clofarabine

    Intervention · DRUG

  • Cyclophosphamide

    Intervention · DRUG

  • Dexamethasone

    Intervention · DRUG

    Given IV or PO

  • Etoposide

    Intervention · DRUG

  • Ofatumumab

    Intervention · BIOLOGICAL

  • Pegfilgrastim

    Intervention · BIOLOGICAL

  • Rituximab

    Intervention · BIOLOGICAL

  • Vincristine Sulfate Liposome

    Intervention · DRUG

Both Bortezomib and Pegfilgrastim

Given SC

All of Clofarabine, Cyclophosphamide, Etoposide, Ofatumumab, Rituximab, Vincristine Sulfate Liposome

Given IV

Study details

Official title
Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
Sponsor
M.D. Anderson Cancer Center
Conditions
Recurrent Acute Lymphoblastic Leukemia · Recurrent Adult Lymphoblastic Lymphoma · Recurrent Burkitt Leukemia · Recurrent Burkitt Lymphoma · Recurrent Childhood Lymphoblastic Lymphoma · Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements · Refractory Acute Lymphoblastic Leukemia · Refractory Burkitt Leukemia · Refractory Burkitt Lymphoma · Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements · Refractory Lymphoblastic Lymphoma
Enrolling
42 people
Starts
2017-08-09
Est. completion
2027-08-01
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗