RecruitingPhase 2NCT03136146

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia

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)

Sponsor

M.D. Anderson Cancer Center

Enrollment

42 participants

Start Date

Aug 9, 2017

Study Type

INTERVENTIONAL

Conditions

Refractory Acute Lymphoblastic Leukemia 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 Burkitt Leukemia Refractory Burkitt Lymphoma Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements Refractory Lymphoblastic Lymphoma

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of chemotherapy drugs for patients with relapsed or treatment-resistant forms of aggressive blood cancers, including acute lymphoblastic leukemia (ALL), lymphoblastic lymphoma, Burkitt lymphoma, and related cancers. **You may be eligible if...** - Your ALL, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, or double-hit leukemia/lymphoma has come back after treatment or has not responded to treatment - At least 21 days have passed since your last chemotherapy (or at least 14 days for some regimens) - You are in good enough health to receive intensive chemotherapy **You may NOT be eligible if...** - Your cancer has not been diagnosed as one of the specific types listed above - You received chemotherapy too recently - Your overall health is not strong enough to tolerate this treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBortezomib

Given SC

DRUGClofarabine

Given IV

DRUGCyclophosphamide

Given IV

DRUGDexamethasone

Given IV or PO

DRUGEtoposide

Given IV

BIOLOGICALOfatumumab

Given IV

BIOLOGICALPegfilgrastim

Given SC

BIOLOGICALRituximab

Given IV

DRUGVincristine Sulfate Liposome

Given IV

Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT03136146

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