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Combination Chemotherapy for Relapsed/Refractory Lymphoma/Leukemia

This study is testing a combination of chemotherapy drugs for people with certain types of leukemia or lymphoma that have come back or haven't responded to previous treatments. The drugs being studied are clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib. These drugs work in different ways to stop cancer cells from growing and spreading. The main goals are to see how safe this combination is and how well it shrinks the cancer. You may be able to join if you are 15 years or older and have relapsed or refractory acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt leukemia/lymphoma, or "double-hit" leukemia/lymphoma. The study is currently unclear about its recruitment status and plans to enroll 42 participants.

Study design
This is a Phase II interventional study, meaning all participants receive the study treatment. It aims to enroll 42 participants.
What's involved
During the induction phase, you would receive clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib on specific days. Some drugs are given intravenously (into a vein), some subcutaneously (under the skin), and some orally (by mouth).
Compensation
Not stated in the trial record.
Follow-up
Your health and any side effects will be monitored for up to 8 years after treatment. The study will also track how long you respond to treatment and your overall survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03136146

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

Recruiting
PHASE2Ages 15+InterventionalTreatment
M.D. Anderson Cancer Center
~42 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:BortezomibClofarabineCyclophosphamideDexamethasoneEtoposideOfatumumab

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events
Measured over Up to 8 years
+1 more outcome measured

Conditions

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

Explore related trials

Acute Lymphoblastic LeukemiaBurkitt LeukemiaBurkitt LymphomaHigh Grade B-Cell LymphomaLymphoblastic Lymphoma

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Maro Ohanian · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Maro Ohanian
[email protected]
713-745-0394
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

Active \>= grade 3 peripheral neuropathy
Active hepatic graft-versus-host disease
Known positivity for hepatitis B or C
Pregnancy
Breast feeding

What this trial measures

  • Incidence of adverse eventsUp 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)Up to 8 years

    Will be estimated along with the exact 95% confidence interval.