Combination Chemotherapy for Treating Relapsed or Resistant Acute Lymphoblastic Leukemia and Related Cancers

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03136146

Provider View

This clinical trial is testing a combination of chemotherapy drugs to see how well they work and what side effects they might have in patients with certain types of leukemia and lymphoma that have returned or are not responding to treatment.

Patient Parameters

Program Overview

This study is exploring how a combination of chemotherapy drugs can help treat patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or isn't responding to treatment. The chemotherapy drugs used in this trial work in different ways to stop cancer cells from growing, dividing, or spreading.

Description

The main goal of this study is to gather information on the safety and effectiveness of a combination of chemotherapy drugs, including clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib, in treating relapsed or resistant acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL). This includes cases that are Philadelphia positive or involve Burkitt's leukemia/lymphoma or double-hit leukemia/lymphoma.

The study is divided into two parts:

  1. Induction Therapy: Patients will receive a series of chemotherapy drugs over several days, including clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib. Additional medications like ofatumumab or rituximab may also be given. This phase aims to reduce the cancer significantly.

  2. Consolidation Therapy: After the initial treatment, patients will continue to receive chemotherapy to help maintain the response and prevent the cancer from returning. This phase involves similar drugs and is repeated every 28 days for up to five cycles, depending on the patient's response and tolerance.

The study will monitor how long patients remain cancer-free and their overall survival rates after receiving this treatment combination.

Eligibility Criteria

Inclusion Criteria

  • Have relapsed or resistant acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), including specific subtypes like Philadelphia positive or Burkitt's leukemia/lymphoma.
  • At least 21 days since the last chemotherapy treatment, or 14 days if the disease is progressing quickly.
  • Be older than 15 years.
  • Have a performance status score of 3 or less, indicating the ability to perform daily activities with some limitations.
  • Have acceptable liver and kidney function as indicated by specific blood tests.
  • Provide signed informed consent to participate in the study.

Exclusion Criteria

  • Have severe peripheral nerve damage (grade 3 or higher).
  • Have active liver graft-versus-host disease.
  • Test positive for hepatitis B or C.
  • Be pregnant or breastfeeding.

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