Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Burkitt Lymphoma/Leukemia or Double-Hit Lymphoma/Leukemia

  • STATUS
    Recruiting
  • End date
    Aug 1, 2026
  • participants needed
    42
  • sponsor
    M.D. Anderson Cancer Center
Updated on 24 January 2021
lymphoid leukemia
cyclophosphamide
tyrosine
hydroxyurea
rituximab
vincristine
leukemia
lymphocytic leukemia
glomerular filtration rate
etoposide
clofarabine
burkitt's lymphoma
combination chemotherapy
tumor cells
bortezomib
cancer chemotherapy
vincristine sulfate

Summary

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.

Description

PRIMARY OBJECTIVES:

I. To collect the safety/toxicity information and assess the initial efficacy information (objective overall response rate: complete response [CR]+ CR with incomplete platelet recovery [CRp]/CR with incomplete bone marrow recovery [CRi]) after treatment with clofarabine, etoposide, cyclophosphamide (CEC), vincristine sulfate liposome (liposomal vincristine) (VCR), dexamethasone and bortezomib in relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) including relapsed/refractory Philadelphia (Ph) positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.

SECONDARY OBJECTIVES:

I. To determine the CR duration, event free survival (EFS), and overall survival (OS) after treatment with CEC, liposomal VCR, dexamethasone and bortezomib in relapsed/refractory ALL or LL including relapsed/refractory Ph positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.

OUTLINE

INDUCTION: Patients receive clofarabine intravenously (IV) over 1-2 hours on days 1-5, etoposide IV over 2 hours on days 1-5, cyclophosphamide IV over 1 hour on days 1-5, vincristine sulfate liposome IV over 1 hour on days 2 and 11, dexamethasone orally (PO) daily or IV over 15 minutes on days 1-5, bortezomib subcutaneously (SC) on days 1, 4, 8 and 11, ofatumumab or rituximab IV over 4-24 hours on days 2 and 11, and pegfilgrastim SC on day 6 in the absence of disease progression or unacceptable toxicity. Patients may receive 1 additional course of induction therapy depending on the disease response.

CONSOLIDATION THERAPY: Patients receive clofarabine IV over 1-2 hours on days 1-4, etoposide IV over 2 hours on days 1-4, cyclophosphamide IV over 1 hour on days 1-4, vincristine sulfate liposome IV over 1 hour on days 2 and 11, dexamethasone PO or IV over 15 minutes on days 1-5, bortezomib SC on days 1, 4, 8 and 11, pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may receive ofatumumab or rituximab IV over 4-24 hours on days 2 and 11 for 4 courses.

Details
Condition childhood ALL, Burkitt's Lymphoma, B-Cell Lymphoma, Lymphoma, B-Cell, Refractory Acute Lymphoblastic Leukemia, Recurrent Adult Lymphoblastic Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Burkitt Lymphoma, Refractory Burkitt Lymphoma, Lymphocytic Leukemia, Acute, Hematopoietic/Lymphoid Cancer, Burkitt Leukemia/Lymphoma, Recurrent Acute Lymphoblastic Leukemia, Hematopoietic/Lymphoid Cancer, Burkitt Leukemia/Lymphoma, Hematopoietic/Lymphoid Cancer, Burkitt Leukemia/Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent Burkitt Leukemia, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory Burkitt Leukemia, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory Lymphoblastic Lymphoma, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, b all, High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements, Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Treatment Rituximab, cyclophosphamide, etoposide, Dexamethasone, Bortezomib, Clofarabine, pegfilgrastim, Ofatumumab, Vincristine Sulfate Liposome, Liposomal vincristine
Clinical Study IdentifierNCT03136146
SponsorM.D. Anderson Cancer Center
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: Recurrent Adult Lymphoblastic Lymphoma or Refractory Burkitt Lymphoma or Recurrent Burkitt Leukemia or Refractory Acute Lymphoblastic Leukemia or Burk...?
Do you have any of these conditions: Recurrent Adult Lymphoblastic Lymphoma or Refractory Burkitt Leukemia or Recurrent Childhood Lymphoblastic Lymphoma or Recurrent High Grade B-Cell Lym...?
Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (Lead-in and Phase 2)
Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (2 separate cohorts, phase II only)
At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (There may be certain patients with performance status [PS] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)
Serum bilirubin =< 1.5 mg/dL
Serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome
Estimated creatinine clearance or GFR (glomerular filtration rate) >= 50 mL/min
Signed informed consent

Exclusion Criteria

Active >= grade 3 peripheral neuropathy
Active hepatic graft-versus-host disease
Known positivity for hepatitis B or C
Pregnancy
Breast feeding after pregnant
Clear my responses

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