Health Trials

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

ConditionsRecurrent Acute Lymphoblastic LeukemiaRecurrent Adult Lymphoblastic LymphomaRecurrent Burkitt LeukemiaRecurrent Burkitt LymphomaRecurrent Childhood Lymphoblastic LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory Acute Lymphoblastic LeukemiaRefractory Burkitt LeukemiaRefractory Burkitt LymphomaRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age15+
SponsorM.D. Anderson Cancer Center

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Active >= grade 3 peripheral neuropathy

Active hepatic graft-versus-host disease

Known positivity for hepatitis B or C

Pregnancy

Trial design

Treatments tested in this trial

  • Bortezomib
  • Clofarabine
  • Cyclophosphamide
  • Dexamethasone
  • Etoposide
  • Ofatumumab
  • Pegfilgrastim
  • Rituximab
  • Vincristine Sulfate Liposome

Treatment groups

42 Participants
are divided into 1 treatment group

Sponsors and collaborators

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov