RecruitingPhase 2NCT03136146

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

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

Enrollment

42 participants

Start Date

Aug 9, 2017

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 15 Years

Inclusion Criteria10

  • Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):
  • Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)
  • Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (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
  • Age older than 15 years
  • 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 Criteria5

  • Active \>= grade 3 peripheral neuropathy
  • Active hepatic graft-versus-host disease
  • Known positivity for hepatitis B or C
  • Pregnancy
  • Breast feeding

Interventions

DRUGBortezomib

Given SC

DRUGClofarabine

Given IV

DRUGCyclophosphamide

Given IV

DRUGDexamethasone

Given IV or PO

DRUGEtoposide

Given IV

BIOLOGICALOfatumumab

Given IV

BIOLOGICALPegfilgrastim

Given SC

BIOLOGICALRituximab

Given IV

DRUGVincristine Sulfate Liposome

Given IV


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT03136146


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