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)

Who is this study for? Patients with Acute Lymphoblastic Leukemia
Status: Recruiting
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 15
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2017-08-09
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 42
Treatments
Experimental: Treatment (combination chemotherapy)
See detailed description
Sponsors
Leads: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

Similar Clinical Trials