Combination chemotherapy for returning or resistant leukemia and lymphoma
Tests combined chemotherapy drugs in people with leukemia or lymphoma that returned.
Plain-language title generated from the registry record
Registry title: Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
Key facts
- Where
- Houston, United StatesSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people older than 15 whose acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt or double-hit lymphoma/leukemia has come back or did not respond to treatment.
- Age
- Older than 15 years
- Sex
- All sexes
- Disease stage
- Relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma, Philadelphia negative (lead-in and phase II). Philadelphia positive ALL, Burkitt or double-hit leukemia/lymphoma (phase II only).
- Earlier treatment
- At least 21 days since the last systemic chemotherapy. At least 14 days if the disease is progressing rapidly without major lasting side effects outside the bone marrow. Hydroxyurea and dexamethasone are allowed until about 24 hours before starting.
- Biomarker or test result
- Philadelphia chromosome status is used to decide the group: negative or positive.
Main reasons for not taking part
- Active peripheral neuropathy of grade 3 or higher
- Active graft-versus-host disease of the liver
- Known hepatitis B or C
- Pregnancy
- Breast feeding
Read by machine on 9 November 2026.
Where in United States
- M D Anderson Cancer CenterHouston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- M.D. Anderson Cancer Center
- Trial code
- NCT03136146
- Record updated
- 10 August 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: 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: Active hepatic graft-versus-host disease; Known positivity for hepatitis B or C; Active >= grade 3 peripheral neuropathy; Pregnancy; Breast feeding.