Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia
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|ClinicalTrials.gov Identifier: NCT03136146|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Burkitt Leukemia High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Recurrent Acute Lymphoblastic Leukemia Recurrent Adult Lymphoblastic Lymphoma Recurrent Burkitt Leukemia Recurrent Burkitt Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Refractory Acute Lymphoblastic Leukemia Refractory Burkitt Leukemia Refractory Burkitt Lymphoma Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Refractory Lymphoblastic Lymphoma||Drug: Bortezomib Drug: Clofarabine Drug: Cyclophosphamide Drug: Dexamethasone Drug: Etoposide Biological: Ofatumumab Biological: Pegfilgrastim Biological: Rituximab Drug: Vincristine Sulfate Liposome||Phase 2|
I. To collect the safety/toxicity information and assess the initial efficacy information (objective overall response rate: complete response [CR]+ CR with incomplete platelet recovery [CRp]/CR with incomplete bone marrow recovery [CRi]) after treatment with clofarabine, etoposide, cyclophosphamide (CEC), vincristine sulfate liposome (liposomal vincristine) (VCR), dexamethasone and bortezomib in relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) including relapsed/refractory Philadelphia (Ph) positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.
I. To determine the CR duration, event free survival (EFS), and overall survival (OS) after treatment with CEC, liposomal VCR, dexamethasone and bortezomib in relapsed/refractory ALL or LL including relapsed/refractory Ph positive B-ALL/LL or Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.
INDUCTION: Patients receive clofarabine intravenously (IV) over 1-2 hours on days 1-5, etoposide IV over 2 hours on days 1-5, cyclophosphamide IV over 1 hour on days 1-5, vincristine sulfate liposome IV over 1 hour on days 2 and 11, dexamethasone orally (PO) daily or IV over 15 minutes on days 1-5, bortezomib subcutaneously (SC) on days 1, 4, 8 and 11, ofatumumab or rituximab IV over 4-24 hours on days 2 and 11, and pegfilgrastim SC on day 6 in the absence of disease progression or unacceptable toxicity. Patients may receive 1 additional course of induction therapy depending on the disease response.
CONSOLIDATION THERAPY: Patients receive clofarabine IV over 1-2 hours on days 1-4, etoposide IV over 2 hours on days 1-4, cyclophosphamide IV over 1 hour on days 1-4, vincristine sulfate liposome IV over 1 hour on days 2 and 11, dexamethasone PO or IV over 15 minutes on days 1-5, bortezomib SC on days 1, 4, 8 and 11, pegfilgrastim SC on day 6. Treatment repeats every 28 days for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients may receive ofatumumab or rituximab IV over 4-24 hours on days 2 and 11 for 4 courses.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||August 9, 2017|
|Estimated Primary Completion Date :||August 1, 2025|
|Estimated Study Completion Date :||August 1, 2026|
Experimental: Treatment (combination chemotherapy)
See detailed description
Given IV or PO
Drug: Vincristine Sulfate Liposome
Other Name: Marqibo
- Incidence of adverse events [ Time Frame: Up to 8 years ]The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events.
- Overall response rate (ORR) (Phase II) [ Time Frame: Up to 8 years ]Will be estimated along with the exact 95% confidence interval.
- Overall survival [ Time Frame: From initiation of treatment, assessed up to 8 years ]Will be estimated using the method of Kaplan and Meier. The log-rank tests will be used to compare the time-to-event outcomes among subgroups of patients.
- Event free survival [ Time Frame: From the treatment start, assessed up to 8 years ]Will be estimated using the method of Kaplan and Meier. The log-rank tests will be used to compare the time-to-event outcomes among subgroups of patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03136146
|Contact: Maro Ohanian, DOfirstname.lastname@example.org|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Maro Ohanian 713-792-2631|
|Principal Investigator: Maro Ohanian|
|Principal Investigator:||Maro Ohanian||M.D. Anderson Cancer Center|