Actively Recruiting
Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide, Liposomal Vincristine, Dexamethasone and Bortezomib in Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
Led by M.D. Anderson Cancer Center · Updated on 2026-02-17
42
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating combination chemotherapy for patients aged 15 years and older with relapsed or refractory acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma (LL), Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia. This phase II trial aims to study the side effects and initial effectiveness of drugs including clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib. The study also focuses on safety, toxicity, and response rates in these hard-to-treat blood cancers. During the induction phase, patients receive intravenous clofarabine, etoposide, and cyclophosphamide on days 1-5, vincristine sulfate liposome on days 2 and 11, oral or intravenous dexamethasone daily on days 1-5, subcutaneous bortezomib on days 1, 4, 8, and 11, intravenous ofatumumab or rituximab on days 2 and 11, and subcutaneous pegfilgrastim on day 6 if no progression or severe toxicity occurs. An additional induction course may be given based on response. The consolidation phase includes similar medications given over days 1-4 or 1-5, with treatment repeating every 28 days for up to five courses. Ofatumumab or rituximab may be administered during consolidation for four courses. Participants will be monitored for adverse events and treatment responses over up to eight years. Assessments include safety evaluations and measuring overall response rates, survival time without events, and overall survival. The study involves multiple visits for drug administration and follow-up, with careful monitoring for toxicity and disease progression. The total duration of participation may extend up to eight years for long-term outcome tracking.
CONDITIONS
Brief 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...
- Diagnosis of relapsed or refractory acute lymphoblastic leukemia or lymphoblastic lymphoma
- Relapsed/refractory Philadelphia negative ALL or LL for lead-in and phase II; relapsed/refractory Philadelphia positive ALL, Burkitt leukemia/lymphoma, or double-hit leukemia/lymphoma for phase II only
- At least 21 days since prior systemic chemotherapy, or 14 days if disease is rapidly progressing without significant extramedullary toxicity
- Age 15 years or older
- ECOG performance status of 3 or less
- Serum bilirubin 1.5 mg/dL or less
- Serum glutamate pyruvate transaminase (SGPT) 3 times upper limit normal or less (except for Gilbert's syndrome)
- Creatinine clearance or glomerular filtration rate (GFR) of 50 mL/min or more
- Signed informed consent
You will not qualify if you...
- Active grade 3 or higher peripheral neuropathy
- Active hepatic graft-versus-host disease
- Known positive test for hepatitis B or C
- Pregnancy
- Breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction: 5 days with possible additional induction; Consolidation: up to 5 courses repeating every 28 days
Participants receive combination chemotherapy consisting of clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, bortezomib, and may receive ofatumumab or rituximab. The induction phase lasts 5 days, with possible additional induction course depending on response. This is followed by consolidation therapy repeating every 28 days for up to 5 courses, including the same drugs and additional antibody treatments for 4 courses.
Multiple visits during induction and consolidation cycles including days 1-5 and days 2 and 11 for some drugs
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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