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Proteasome inhibitor

Combination Chemotherapy for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Led By Maro Ohanian
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age older than 15 years
Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (Lead-in and Phase II)
Must not have
Active hepatic graft-versus-host disease
Active >= grade 3 peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

Summary

This trial tests a combination of chemotherapy drugs to treat patients with certain types of leukemia and lymphoma that have returned or don't respond to usual treatments. The drugs work together to kill cancer cells and stop them from growing. The study aims to see how safe and effective this treatment is.

Who is the study for?
This trial is for people over 15 with certain types of blood cancers like acute lymphoblastic leukemia or Burkitt lymphoma that have returned or are treatment-resistant. Participants need normal liver function, not be pregnant or breastfeeding, and can't have severe nerve damage or active hepatitis B/C.
What is being tested?
The study tests a combination chemotherapy regimen using drugs like clofarabine, etoposide, cyclophosphamide, and others to see how well they work against aggressive blood cancers when previous treatments failed.
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, bleeding problems from low platelets and potential damage to organs like the heart and kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 15 years.
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My leukemia or lymphoma has returned or didn't respond to treatment and is not Philadelphia chromosome positive.
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My kidneys are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active liver complications from a transplant.
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I have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of adverse events
Overall response rate (ORR) (Phase II)
Secondary study objectives
Event free survival
Overall survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy)Experimental Treatment9 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2650
Pegfilgrastim
2013
Completed Phase 3
~4440
Clofarabine
2007
Completed Phase 3
~1130
Bortezomib
2005
Completed Phase 3
~1410
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580
Cyclophosphamide
2010
Completed Phase 4
~2320
Ofatumumab
2013
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~2200
Etoposide
2010
Completed Phase 3
~2960

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Combination chemotherapy is a common treatment for T-Lymphoblastic Lymphoma/Leukemia, utilizing multiple drugs that work through various mechanisms to combat the disease. These drugs include agents like clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib. They kill tumor cells by inducing apoptosis, inhibit cell division by interfering with DNA replication and mitosis, and prevent the spread of cancer cells by disrupting cellular processes essential for metastasis. This multifaceted approach is vital for T-Lymphoblastic Lymphoma/Leukemia patients due to the aggressive nature of the disease, aiming to improve survival rates and reduce the likelihood of relapse.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,048 Previous Clinical Trials
1,799,899 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,010,735 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
158 Total Patients Enrolled

Media Library

Bortezomib (Proteasome inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03136146 — Phase 2
T-Lymphoblastic Lymphoma/Leukemia Research Study Groups: Treatment (combination chemotherapy)
T-Lymphoblastic Lymphoma/Leukemia Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT03136146 — Phase 2
Bortezomib (Proteasome inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03136146 — Phase 2
~4 spots leftby Aug 2025