Actively Recruiting
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-02-17
42
Participants Needed
1
Research Sites
520 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), including Philadelphia negative and Philadelphia positive types, Burkitt leukemia/lymphoma, or double-hit leukemia/lymphoma as specified
- At least 21 days since prior systemic chemotherapy (14 days allowed for rapidly progressing disease without significant residual toxicity)
- Hydroxyurea and dexamethasone allowed up to about 24 hours before starting therapy
- No interruption required for tyrosine kinase inhibitor treatment in Philadelphia positive ALL subset
- Age older than 15 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
- Serum bilirubin 1.5 mg/dL or less
- Serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 times the upper limit normal (ULN), except for Gilbert's syndrome
- Estimated creatinine clearance or glomerular filtration rate (GFR) of 50 mL/min or higher
- Signed informed consent
You will not qualify if you...
- Active peripheral neuropathy at grade 3 or higher
- Active hepatic graft-versus-host disease
- Known positive test for hepatitis B or hepatitis C
- Pregnancy
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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