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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age15 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• 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

You cannot join if

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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

bortezomib. A dipeptide boronic acid analogue with antineoplastic activity. Bortezomib reversibly inhibits the 26S proteasome, a large protease complex that degrades ubiquinated proteins. By blocking the targeted proteolysis normally performed by the proteasome, bortezomib disrupts various cell signaling pathways, leading to cell cycle arrest, apoptosis, and inhibition of angiogenesis. Specifically, the agent inhibits nuclear factor (NF)-kappaB, a protein that is constitutively activated in some cancers, thereby interfering with NF-kappaB-mediated cell survival, tumor growth, and angiogenesis. In vivo, bortezomib delays tumor growth and enhances the cytotoxic effects of radiation and chemotherapy. NCI Drug Dictionary

Treatments listed in the registry

• Bortezomib (Drug): Given SC
• Clofarabine (Drug): Given IV
• Cyclophosphamide (Drug): Given IV
• Dexamethasone (Drug): Given IV or PO
• Etoposide (Drug): Given IV
• Ofatumumab (Biological): Given IV
• Pegfilgrastim (Biological): Given SC
• Rituximab (Biological): Given IV
• Vincristine Sulfate Liposome (Drug): Given IV

Na · Single Group · masking: None

Main goals

• Incidence of adverse events (Up to 8 years)
• Overall response rate (ORR) (Phase II) (Up to 8 years)

Other goals

• Overall survival
• Event free survival

Planned enrollment: 42 (estimated).

• M D Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT03136146
• NCI Drug Dictionary: C1851

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 9, 2026. Public record; not medical advice.